Awake Prone Position in Hypoxemic Patients with Coronavirus Disease 19 (COVI-PRONE): A Study protocol and Statistical Analysis Plan for Randomized Clinical Trial

Background Coronavirus disease 2019 (COVID-19), may progress to respiratory failure requiring invasive mechanical ventilation. Due to ventilator shortage and healthcare systems strain, affordable interventions such as awake prone positioning has been used to improve oxygenation, however, the effect of this intervention on patient-important outcomes is uncertain. The COVI-PRONE trial aims to determine if awake prone positioning in hypoxemic COVID-19 patients reduces the need for invasive mechanical ventilation. Study design A pragmatic, multicenter, international, parallel-group, and stratified randomized controlled trial, aiming to enrol 400 hospitalized adults with COVID-19. Participants The target population is hospitalized adults with confirmed or suspected COVID-19, hypoxemia that requires ≥40% oxygen or ≥ 5 L/min by nasal cannula, and abnormal chest x-ray. We will exclude patients with any of the following: immediate need for intubation; altered mental status; contraindication to prone positioning; hemodynamic instability; body mass index > 40 kg/m2; third trimester pregnancy; do not intubate status; previous enrolment or intubation within the same hospital admission; and prone positioning for more than one day prior to randomization. Study intervention and control Following informed a priori or deferred consent, eligible patients will be centrally randomized to either the intervention arm (prone positioning) or standard of care (no prone positioning). Patients randomized to the prone position will be required to either self-prone or assist-prone for a total of eight to ten hours per day until they meet pre-specified stopping criteria. Study outcomes The primary outcome is invasive mechanical ventilation at 30-days of randomization. Other outcomes include mortality at 60 days, invasive and non-invasive mechanical ventilation free days at 30 days, hospital length of stay at 60 days, days alive and outside of the hospital at 60 days, complications of proning, and serious adverse events.

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Prone positioning in non-intubated patients with COVID-19 associated acute respiratory failure, the PRO-CARF trial: A structured summary of a study protocol for a randomised controlled trial

Trials ◽

10.1186/s13063-020-04882-2 ◽

2020 ◽

Vol 21 (1) ◽

Author(s):

Miguel Á. Ibarra-Estrada ◽

Miguel Marín-Rosales ◽

Roxana García-Salcido ◽

Sara A. Aguirre-Díaz ◽

Alexandra Vargas-Obieta ◽

...

Keyword(s):

Mechanical Ventilation ◽

Respiratory Failure ◽

Acute Respiratory Failure ◽

Prone Position ◽

Controlled Trial ◽

Control Group ◽

Intubation Rate ◽

Prone Positioning ◽

Registration Number ◽

Full Protocol

Abstract Objectives To assess the effect of prone positioning therapy on intubation rate in awake patients with COVID-19 and acute respiratory failure. Trial design This is a two-center parallel group, superiority, randomized (1:1 allocation ratio) controlled trial. Participants All patients admitted to the Hospital Civil de Guadalajara and Hospital General de Occidente in Mexico for COVID-19 associated acute respiratory failure and in need of supplementary oxygen through high-flow nasal cannula are screened for eligibility. Inclusion criteria: all adult patients admitted to the COVID-19 unit who test positive for COVID-19 by PCR-test and in need for oxygen are eligible for inclusion. Randomization starts upon identification of requirement of a fraction of inspired oxygen ≥30% for an oxygen capillary saturation of ≥90% Exclusion criteria: less than 18 years-old, pregnancy, patients with immediate need of invasive mechanical ventilation (altered mental status, fatigue), vasopressor requirement to maintain median arterial pressure >65 mmHg, contraindications for prone positioning therapy (recent abdominal or thoracic surgery or trauma, facial, pelvic or spine fracture, untreated pneumothorax, do-not-resuscitate or do-not-intubate order, refusal or inability of the patient to enroll in the study. Intervention and comparator Patients of the intervention group will be asked to remain in a prone position throughout the day as long as possible, with breaks according to tolerance. Pillows will be offered for maximizing comfort at chest, pelvis and knees. Monitoring of vital signs will not be suspended. Inspired fraction of oxygen will be titrated to maintain a capillary saturation of 92%-95%. For patients in the control group, prone positioning will be allowed as a rescue therapy. Staff intensivists will monitor the patient’s status in both groups on a 24/7 basis. All other treatment will be unchanged and left to the attending physicians. Main outcomes Endotracheal intubation rate for mechanical ventilation at 28 days. Randomisation Patients will be randomly allocated to either prone positioning or control group at 1:1 ratio. Such randomization will be computer generated and stratified by center with permuted blocks and length of 4. Blinding (masking) Due to logistical reasons, only principal investigators and the data analyst will be blinded to group assignment. Numbers to be randomised (sample size) With an intubation rate of 60% according to recent reports from some American centers, and assuming a decrease to 40% to be clinically relevant, we calculated a total of 96 patients per group, for a beta error of 0.2, and alpha of 0.5. Therefore, we plan to recruit 200 patients, accounting for minimal losses to follow up, with 100 non-intubated patients in the prone position group and a 100 in the control group. Trial Status The local registration number is 048-20, with the protocol version number 2.0. The date of approval is 3rd May 2020. Recruitment started on 3rd May and is expected to end in December 2020. Trial registration The protocol was retrospectively registered under the title: “Prone Positioning in Non-intubated Patients With COVID-19 Associated Acute Respiratory Failure. The PRO-CARF trial” in ClinicalTrials.gov with the registration number: NCT04477655. Registered on 20 July 2020. Full protocol The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol. The study protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines (Additional file 2).

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Efficacy and safety of exogenous surfactant therapy in patients under 12 months of age invasively ventilated for severe bronchiolitis (SURFABRON): protocol for a multicentre, randomised, double-blind, controlled, non-profit trial

BMJ Open ◽

10.1136/bmjopen-2020-038780 ◽

2020 ◽

Vol 10 (10) ◽

pp. e038780

Author(s):

Paolo Biban ◽

Giorgio Conti ◽

Andrea Michele Wolfler ◽

Silvia Carlassara ◽

Eloisa Gitto ◽

...

Keyword(s):

Mechanical Ventilation ◽

Invasive Mechanical Ventilation ◽

University Hospital ◽

Hospital Length Of Stay ◽

Surfactant Therapy ◽

Exogenous Surfactant ◽

Double Blind Study ◽

National Agency ◽

Serious Adverse Events ◽

Double Blind

IntroductionSome evidence indicates that exogenous surfactant therapy may be effective in infants with acute viral bronchiolitis, even though more confirmatory data are needed. To date, no large multicentre trials have evaluated the effectiveness and safety of exogenous surfactant in severe cases of bronchiolitis requiring invasive mechanical ventilation (IMV).Methods and analysisThis is a multicentre randomised, placebo-controlled, double-blind study, performed in 19 Italian paediatric intensive care units (PICUs). Eligible participants are infants under the age of 12 months hospitalised in a PICU, suffering from severe acute hypoxaemic bronchiolitis, requiring IMV. We adopted a more restrictive definition of bronchiolitis, including only infants below 12 months of age, to maintain the population as much homogeneous as possible. The primary outcome is to evaluate whether exogenous surfactant therapy (Curosurf, Chiesi Pharmaceuticals, Italy) is effective compared with placebo (air) in reducing the duration of IMV in the first 14 days of hospitalisation, in infants suffering from acute hypoxaemic viral bronchiolitis. Secondary outcomes are duration of non-invasive mechanical ventilation in the post-extubation phase, number of cases requiring new intubation after previous extubation within 14 days from randomisation, PICU and hospital length of stay (LOS), duration of oxygen dependency, effects on oxygenation and ventilatory parameters during invasive mechanical respiratory support, need for repeating treatment within 24 hours of first treatment, use of other interventions (eg, high-frequency oscillatory ventilation, nitric oxide, extracorporeal membrane oxygenation), mortality within the first 14 days of PICU stay and before hospital discharge, side effects and serious adverse events.Ethics and disseminationThe trial design and protocol have received approval by the Italian National Agency for Drugs (AIFA) and by the Regional Ethical Committee of Verona University Hospital (1494CESC). Findings will be disseminated through publication in peer-reviewed journals, conference/meeting presentations and media.Trial registration numberClinicaltrials.gov, issue date 22 May 2019. NCT03959384.

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Impact of dexamethasone on the incidence of ventilator-associated pneumonia and blood stream infections in COVID-19 patients requiring invasive mechanical ventilation: a multicenter retrospective study

Annals of Intensive Care ◽

10.1186/s13613-021-00876-8 ◽

2021 ◽

Vol 11 (1) ◽

Author(s):

Ines Gragueb-Chatti ◽

Alexandre Lopez ◽

Dany Hamidi ◽

Christophe Guervilly ◽

Anderson Loundou ◽

...

Keyword(s):

Mechanical Ventilation ◽

Retrospective Study ◽

Length Of Stay ◽

Critically Ill ◽

Invasive Mechanical Ventilation ◽

Blood Stream ◽

Hospital Length Of Stay ◽

Ventilator Associated Pneumonia ◽

Blood Stream Infections ◽

Second Wave

Abstract Background Dexamethasone decreases mortality in patients with severe coronavirus disease 2019 (COVID-19) and has become the standard of care during the second wave of pandemic. Dexamethasone is an immunosuppressive treatment potentially increasing the risk of secondary hospital acquired infections in critically ill patients. We conducted an observational retrospective study in three French intensive care units (ICUs) comparing the first and second waves of pandemic to investigate the role of dexamethasone in the occurrence of ventilator-associated pneumonia (VAP) and blood stream infections (BSI). Patients admitted from March to November 2020 with a documented COVID-19 and requiring mechanical ventilation (MV) for ≥ 48 h were included. The main study outcomes were the incidence of VAP and BSI according to the use of dexamethasone. Secondary outcomes were the ventilator-free days (VFD) at day-28 and day-60, ICU and hospital length of stay and mortality. Results Among the 151 patients included, 84 received dexamethasone, all but one during the second wave. VAP occurred in 63% of patients treated with dexamethasone (DEXA+) and 57% in those not receiving dexamethasone (DEXA−) (p = 0.43). The cumulative incidence of VAP, considering death, duration of MV and late immunosuppression as competing factors was not different between groups (p = 0.59). A multivariate analysis did not identify dexamethasone as an independent risk factor for VAP occurrence. The occurrence of BSI was not different between groups (29 vs. 30%; p = 0.86). DEXA+ patients had more VFD at day-28 (9 (0–21) vs. 0 (0–11) days; p = 0.009) and a reduced ICU length of stay (20 (11–44) vs. 32 (17–46) days; p = 0.01). Mortality did not differ between groups. Conclusions In this cohort of COVID-19 patients requiring invasive MV, dexamethasone was not associated with an increased incidence of VAP or BSI. Dexamethasone might not explain the high rates of VAP and BSI observed in critically ill COVID-19 patients.

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Standard Care Versus Awake Prone Position in Adult Nonintubated Patients With Acute Hypoxemic Respiratory Failure Secondary to COVID-19 Infection—A Multicenter Feasibility Randomized Controlled Trial

Journal of Intensive Care Medicine ◽

10.1177/08850666211014480 ◽

2021 ◽

pp. 088506662110144

Author(s):

Devachandran Jayakumar ◽

Pratheema Ramachandran, DNB ◽

Ebenezer Rabindrarajan, DNB ◽

Bharath Kumar Tirupakuzhi Vijayaraghavan, MD ◽

Nagarajan Ramakrishnan, AB ◽

...

Keyword(s):

Respiratory Failure ◽

Prone Position ◽

Feasibility Study ◽

Standard Care ◽

Controlled Trial ◽

Prone Positioning ◽

Hypoxemic Respiratory Failure ◽

Randomized Controlled ◽

Significant Difference ◽

Hypoxic Respiratory Failure

Rationale: The feasibility and safety of awake prone positioning and its impact on outcomes in non-intubated patients with acute respiratory distress syndrome secondary to COVID-19 is unknown. Results of the observational studies published during this pandemic have been conflicting. In this context, we conducted a multi-center, parallel group, randomized controlled feasibility study on awake prone positioning in non-intubated patients with COVID-19 pneumonia requiring supplemental oxygen. Methods: 60 patients with acute hypoxic respiratory failure secondary to COVID-19 pneumonia requiring 4 or more liters of oxygen to maintain a saturation of ≥92% were recruited in this study. Thirty patients each were randomized to either standard care or awake prone group. Patients randomized to the prone group were encouraged to self-prone for at least 6 hours a day. The primary outcome was the proportion of patients adhering to the protocol in each group. Results: In the prone group, 43% (13 out of 30) of patients were able to self-prone for 6 or more hours a day. In the supine group, 47% (14 out of 30) were completely supine and 53% spent some hours in the prone position, but none exceeded 6 hours. There was no significant difference in any of the secondary outcomes between the 2 groups and there were no adverse events. Conclusions: Awake prone positioning in non-intubated patients with acute hypoxic respiratory failure is feasible and safe under clinical trial conditions. The results of our feasibility study will potentially help in the design of larger definitive trials to address this key knowledge gap.

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Extracorporeal carbon dioxide removal for treatment of exacerbated chronic obstructive pulmonary disease (ORION): study protocol for a randomised controlled trial

Trials ◽

10.1186/s13063-021-05692-w ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Tommaso Tonetti ◽

Lara Pisani ◽

Irene Cavalli ◽

Maria Laura Vega ◽

Elisa Maietti ◽

...

Keyword(s):

Mechanical Ventilation ◽

Controlled Trial ◽

Invasive Mechanical Ventilation ◽

Chronic Obstructive ◽

Invasive Ventilation ◽

Obstructive Pulmonary Disease ◽

Non Invasive ◽

Non Invasive Ventilation ◽

Acute Exacerbations

Abstract Background Hypercapnic exacerbations are severe complications of chronic obstructive pulmonary disease (COPD), characterized by negative impact on prognosis, quality of life and healthcare costs. The present standard of care for acute exacerbations of COPD is non-invasive ventilation; when it fails, the use of invasive mechanical ventilation is inevitable, but is associated with extremely poor prognosis. Extracorporeal circuits designed to remove CO2 (ECCO2R) may enhance the efficacy of NIV to remove CO2 and avoid the worsening of respiratory acidosis, which inevitably leads to failure of non-invasive ventilation. Although the use of ECCO2R for acute exacerbations of COPD is steadily increasing, solid evidence on its efficacy and safety is scarce, thus the need for a randomized controlled trial. Methods multicenter randomized controlled unblinded clinical trial including 284 (142 per arm) patients with acute hypercapnic respiratory failure caused by exacerbation of COPD, requiring respiratory support with NIV. The primary outcome is event free survival at 28 days, a composite outcome defined by survival in absence of prolonged mechanical ventilation, severe hypoxemia, septic shock and second episode of COPD exacerbation. Secondary outcomes are incidence of endotracheal intubation and tracheostomy, intensive care and hospital length-of-stay and 90-day mortality. Discussion Acute exacerbations of COPD represent a significant burden in terms of prognosis, quality of life and healthcare costs. Lack definite evidence despite increasing use of ECCO2R justifies a randomized trial to evaluate whether patients with acute hypercapnic acidosis not responsive to NIV should undergo invasive mechanical ventilation (with all serious related risks) or be treated with ECCO2R to avoid invasive ventilation but be exposed to possible adverse events of ECCO2R. Owing to its pragmatic nature, sample size and composite primary outcome, this trial aims at providing valuable answers to relevant questions for clinical treatment of acute exacerbations of COPD. Trial registration ClinicalTrials.gov, NCT04582799. Registered 12 October 2020, .

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Invasive mechanical ventilation and prolonged prone position during the COVID-19 pandemic

Medicina Intensiva (English Edition) ◽

10.1016/j.medine.2021.12.002 ◽

2021 ◽

Author(s):

Pablo Concha ◽

Marina Treso-Geira ◽

Clara Esteve-Sala ◽

Cristina Prades-Berengué ◽

Joana Domingo-Marco ◽

...

Keyword(s):

Mechanical Ventilation ◽

Prone Position ◽

Invasive Mechanical Ventilation

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Cuff Leak Test and Airway Obstruction in Mechanically Ventilated ICU Patients (COMIC): a pilot randomised controlled trial protocol

BMJ Open ◽

10.1136/bmjopen-2019-029394 ◽

2019 ◽

Vol 9 (7) ◽

pp. e029394 ◽

Cited By ~ 1

Author(s):

Kimberley Lewis ◽

Sarah Culgin ◽

Roman Jaeschke ◽

Dan Perri ◽

Corry Marchildon ◽

...

Keyword(s):

Mechanical Ventilation ◽

Controlled Trial ◽

Invasive Mechanical Ventilation ◽

Laryngeal Oedema ◽

Leak Test ◽

Icu Patients ◽

Pilot Randomised Controlled Trial ◽

Mechanically Ventilated ◽

Cuff Leak ◽

Randomised Controlled

IntroductionEndotracheal intubation and invasive mechanical ventilation are lifesaving interventions that are commonly performed in the intensive care unit (ICU). Laryngeal oedema is a known complication of intubation that may cause airway obstruction in a patient on extubation. To date, the only test available to predict this complication is the cuff leak test (CLT); however, its diagnostic accuracy and utility remains uncertain. Herein, we report the protocol for the CuffLeak and AirwayObstruction in MechanicallyVentilated ICU Patients (COMIC) pilottrial.Methods and analysisThis will be a multicentred, pragmatic, pilot randomised controlled trial (RCT). We will enrol 100 mechanically ventilated patients in the ICU who are deemed ready for extubation. We will exclude patients at a high risk of laryngeal oedema. All enrolled patients will have a CLT done before extubation. In the intervention arm, the results of the CLT will be communicated to the bedside physician, and decision to extubate will be left to the treating team. In the control arm, respiratory therapist will not communicate the results of the CLT to the treating physician, and the patient will be extubated regardless of the CLT result. Randomisation will be done in a 1:1 allocation ratio, stratified by size of the endotracheal tube and duration of invasive mechanical ventilation.Although we will examine all clinical outcomes relevant for the future COMIC RCT, the primary outcomes of the COMIC pilottrial will be feasibility outcomes including: consent rate, recruitment rate and protocol adherence. Clinical outcomes include postextubation stridor, reintubation, emergency surgical airway, ICU mortality, in hospital mortality, duration of mechanical ventilation and ICU length of stay in days.Ethics and disseminationThe Hamilton Integrated Research Ethics Board, Imam Abdulrahman Bin Faisal University Institutional Review Board and Bioethical Commission of the Jagiellonian University approved this study. The trial results will be disseminated via publication in peer-reviewed journals.Trial registration numberNCT03372707.

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Awake prone positioning of hypoxaemic patients with COVID-19: protocol for a randomised controlled open-label superiority meta-trial

BMJ Open ◽

10.1136/bmjopen-2020-041520 ◽

2020 ◽

Vol 10 (11) ◽

pp. e041520

Author(s):

Elsa Tavernier ◽

Bairbre McNicholas ◽

Ivan Pavlov ◽

Oriol Roca ◽

Yonatan Perez ◽

...

Keyword(s):

Controlled Trial ◽

Invasive Mechanical Ventilation ◽

Small Sample ◽

High Flow ◽

Occurrence Rate ◽

Prone Positioning ◽

Open Label ◽

Link Type ◽

Randomised Controlled ◽

Nasal High Flow Therapy

IntroductionProne positioning (PP) is an effective first-line intervention to treat patients with moderate to severe acute respiratory distress syndrome (ARDS) receiving invasive mechanical ventilation, as it improves gas exchanges and reduces mortality. The use of PP in awake spontaneous breathing patients with ARDS secondary to COVID-19 was reported to improve oxygenation in few retrospective trials with small sample size. High-level evidence of awake PP for hypoxaemic patients with COVID-19 patients is still lacking.Methods and analysisThe protocol of this meta-trial is a prospective collaborative individual participant data meta-analysis of randomised controlled open label superiority trials. This design is particularly adapted to a rapid scientific response in the pandemic setting. It will take place in multiple sites, among others in USA, Canada, Ireland, France and Spain. Patients will be followed up for 28 days. Patients will be randomised to receive whether awake PP and nasal high flow therapy or standard medical treatment and nasal high flow therapy. Primary outcome is defined as the occurrence rate of tracheal intubation or death up to day 28. An interim analysis plan has been set up on aggregated data from the participating research groups.Ethics and disseminationEthics approvals were obtained in all participating countries. Results of the meta-trial will be submitted for publication in a peer-reviewed journal. Each randomised controlled trial was registered individually, as follows: NCT04325906, NCT04347941, NCT04358939, NCT04395144 and NCT04391140.

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Effects of Methylprednisolone on Ventilator-Free Days in Mechanically Ventilated Patients with Acute Respiratory Distress Syndrome and COVID-19

10.20944/preprints202101.0177.v1 ◽

2021 ◽

Author(s):

Mohamed Badr ◽

Bruno De Oliveira ◽

Khaled Abdallah ◽

Ashraf Nadeem ◽

Yeldho Varghese ◽

...

Keyword(s):

Mechanical Ventilation ◽

Acute Respiratory Distress Syndrome ◽

Length Of Stay ◽

Competing Risks ◽

Primary Outcome ◽

Distress Syndrome ◽

Invasive Mechanical Ventilation ◽

Hospital Length ◽

Blood Cultures ◽

Hospital Length Of Stay

Objectives: There are limited data regarding the efficacy of methylprednisolone in patients with acute respiratory distress syndrome (ARDS) due to coronavirus disease 2019 (COVID-19) requiring invasive mechanical ventilation. We aimed to determine whether methylprednisolone increases the number of ventilator-free days (VFDs) among these patients. Design: Retrospective single-center study Setting: Intensive care unit Patients: All patients with ARDS due to confirmed SARS-CoV-2 infection and requiring invasive mechanical ventilation between 1 March and 29 May 2020 were included Interventions: None Measurements and Main Results: The primary outcome was ventilator-free days (VFDs) during the first 28 days, defined as being alive and free from mechanical ventilation. The primary outcome was analyzed with competing-risks regression based on Fine and Gray’s proportional subhazards model. Death before day 28 was considered to be the competing event. A total of 77 patients met the inclusion criteria. Thirty-two patients (41.6%) received methylprednisolone. The median dose was 1 mg.kg-1 (IQR: 1-1.3 mg.kg-1) and median duration of 5 days (IQR:5-7 days). Patients who received methylprednisolone had a mean 18.8 VFDs (95% CI, 16.6-20.9) during the first 28 days vs. 14.2 VFDs (95% CI, 12.6-16.7) in patients who did not receive methylprednisolone (difference, 4.61; 95% CI, 1.10-8.12; P = 0.001). In the multivariable competing-risks regression analysis and after adjusting for potential confounders (ventilator settings, prone position, organ failure support, severity of the disease, tocilizumab, and inflammatory markers), methylprednisolone was independently associated with a higher number of VFDs (subhazards ratio: 0.10, 95%CI: 0.02-0.45; p=0.003). Hospital mortality did not differ between the two groups (31.2% vs. 28.9%, p=0.82). Hospital length of stay was significantly shorter in the methylprednisolone group (24 days [IQR:15-41 days] vs. 37 days [IQR:23-52 days], p=0.046). The incidence of positive blood cultures was higher in patients who received methylprednisolone (37.5% vs. 17.8%, p=0.052). However, 91% of patients who received methylprednisolone also received tocilizumab. The number of days with hyperglycemia was similar in the two groups. Conclusions: Methylprednisolone was independently associated with increased VFDs and shortened hospital length of stay. The combination of methylprednisolone and tocilizumab was associated with a higher rate of positive blood cultures. Further trials are needed to evaluate the benefits and safety of methylprednisolone in moderate or severe COVID-19 ARDS.

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Feasibility, tolerance and effectiveness of enteral feeding in critically ill patients in prone position

Journal of the Intensive Care Society ◽

10.1177/1751143719900100 ◽

2020 ◽

pp. 175114371990010 ◽

Cited By ~ 1

Author(s):

Raymond Dominic Savio ◽

Rajalakshmi Parasuraman ◽

Daphnee Lovesly ◽

Bhuvaneshwari Shankar ◽

Lakshmi Ranganathan ◽

...

Keyword(s):

Mechanical Ventilation ◽

Enteral Nutrition ◽

Critically Ill ◽

Prone Position ◽

Supine Position ◽

Critically Ill Patients ◽

Invasive Mechanical Ventilation ◽

Apache Ii ◽

Apache Ii Score ◽

The Mean

Aim To assess the feasibility, tolerance and effectiveness of enteral nutrition in critically ill patients receiving invasive mechanical ventilation in the prone position for severe Acute Respiratory Distress Syndrome (ARDS). Methods Prospective observational study conducted in a multidisciplinary critical care unit of a tertiary care hospital from January 2013 until July 2015. All patients with ARDS who received invasive mechanical ventilation in prone position during the study period were included. Patients’ demographics, severity of illness (Acute Physiology and Chronic Health Evaluation (APACHE II) score), baseline markers of nutritional status (subjective global assessment (SGA) and body mass index), details of nutrition delivery during prone and supine hours and outcomes (Length of stay and discharge status) were recorded. Results Fifty-one patients met inclusion criteria out of whom four patients were excluded from analysis since they did not receive any enteral nutrition due to severe hemodynamic instability. The mean age of patients was 46.4 ± 12.9 years, with male:female ratio of 7:3. On admission, SGA revealed moderate malnutrition in 51% of patients and the mean APACHE II score was 26.8 ± 9.2. The average duration of prone ventilation per patient was 60.2 ± 30.7 h. All patients received continuous nasogastric/orogastric feeds. The mean calories (kcal/kg/day) and protein (g/kg/day) prescribed in the supine position were 24.5 ± 3.8 and 1.1 ± 0.2 while the mean calories and protein prescribed in prone position were 23.5 ± 3.6 and 1.1 ± 0.2, respectively. Percentage of prescribed calories received by patients in supine position was similar to that in prone position (83.2% vs. 79.6%; P = 0.12). Patients received a higher percentage of prescribed protein in supine compared to prone position (80.8% vs. 75%, P = 0.02). The proportion of patients who received at least 75% of the caloric and protein goals was 37 (78.7%) and 37 (78.7%) in supine and 32 (68.1%) and 21 (44.6%) in prone position. Conclusion In critically ill patients receiving invasive mechanical ventilation in the prone position, enteral nutrition with nasogastric/orogastric feeding is feasible and well tolerated. Nutritional delivery of calories and proteins in prone position is comparable to that in supine position.

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