scholarly journals Awake prone positioning in nonintubated spontaneous breathing ICU patients with acute hypoxemic respiratory failure (PRONELIFE)—protocol for a randomized clinical trial

Trials ◽  
2022 ◽  
Vol 23 (1) ◽  
Author(s):  
L. Morales-Quinteros ◽  
M. J. Schultz ◽  
A. Serpa-Neto ◽  
M. Antonelli ◽  
D. L. Grieco ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Respiratory Failure ◽  
Tracheal Intubation ◽  
Standard Care ◽  
Total Duration ◽  
Prone Positioning ◽  
Invasive Ventilation ◽  
Hypoxemic Respiratory Failure ◽  
Acute Hypoxemic Respiratory Failure ◽  
Icu Patients

Abstract Background It is uncertain whether awake prone positioning can prevent intubation for invasive ventilation in spontaneous breathing critically ill patients with acute hypoxemic respiratory failure. Awake prone positioning could benefit these patients for various reasons, including a reduction in direct harm to lung tissue, and prevention of tracheal intubation-related complications. Design and methods The PRONELIFE study is an investigator-initiated, international, multicenter, randomized clinical trial in patients who may need invasive ventilation because of acute hypoxemic respiratory failure. Consecutive patients admitted to participating ICUs are randomly assigned to standard care with awake prone positioning, versus standard care without awake prone positioning. The primary endpoint is a composite of tracheal intubation and all-cause mortality in the first 14 days after enrolment. Secondary endpoints include time to tracheal intubation and effects of awake prone positioning on oxygenation parameters, dyspnea sensation, and complications. Other endpoints are the number of days free from ventilation and alive at 28 days, total duration of use of noninvasive respiratory support, total duration of invasive ventilation, length of stay in ICU and hospital, and mortality in ICU and hospital, and at 28, 60, and 90 days. We will also collect data regarding the tolerance of prone positioning. Discussion The PRONELIFE study is among the first randomized clinical trials investigating the effect of awake prone positioning on intubation rate in ICU patients with acute hypoxemic failure from any cause. The PRONELIFE study is sufficiently sized to determine the effect of awake prone positioning on intubation for invasive ventilation—patients are eligible in case of acute hypoxemic respiratory failure without restrictions regarding etiology. The PRONELIFE study is a pragmatic trial in which blinding is impossible—however, as around 35 ICUs worldwide will participate in this study, its findings will be highly generalizable. The findings of the PRONELIFE study have the potential to change clinical management of patients who may need invasive ventilation because of acute hypoxemic respiratory failure. Trial registration ISRCTN ISRCTN11536318. Registered on 17 September 2021. The PRONELIFE study is registered at clinicaltrials.gov with reference number NCT04142736 (October, 2019).

Awake Prone Positioning in Nonintubated Spontaneous Breathing ICU Patients with Acute Hypoxemic Respiratory Failure (PRONELIFE) – Protocol for a Randomized Clinical Trial

2021 ◽  
Author(s):  
Luis Morales-Quinteros ◽  
Marcus J Schultz ◽  
Ary Serpa Neto ◽  
Massimo Antonelli ◽  
Domenico L Grieco ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Respiratory Failure ◽  
Tracheal Intubation ◽  
Standard Care ◽  
Total Duration ◽  
Prone Positioning ◽  
Invasive Ventilation ◽  
Hypoxemic Respiratory Failure ◽  
Acute Hypoxemic Respiratory Failure ◽  
Icu Patients

Abstract BackgroundIt is uncertain whether awake prone positioning can prevent intubation for invasive ventilation in spontaneous breathing critically ill patients with acute hypoxemic respiratory failure. Awake prone positioning could benefit these patients for various reasons, including a reduction in direct harm to lung tissue, and prevention of tracheal intubation related complications.Design and MethodsThe PRONELIFE study is an investigator–initiated, international, multicenter, randomized clinical trial in patients who may need invasive ventilation because of acute hypoxemic respiratory failure. Consecutive patients admitted to participating ICUs are randomly assigned to standard care with awake prone positioning, versus standard care without awake prone positioning. The primary endpoint is a composite of tracheal intubation and all–cause mortality in the first 14 days after enrolment. Secondary endpoints include time to tracheal intubation and effects of awake prone positioning on oxygenation parameters, dyspnea sensation, and complications. Other endpoints are the number of days free from ventilation and alive at 28 days, total duration of use of noninvasive respiratory support, total duration of invasive ventilation, length of stay in ICU and hospital, and mortality in ICU and hospital, and at 28, 60, and 90 days. We will also collect data regarding the tolerance of prone positioning.DiscussionThe PRONELIFE study is amongst the first randomized clinical trials investigating the effect of awake prone positioning on intubation rate in ICU patients with acute hypoxemic failure from any cause. The PRONELIFE study is sufficiently sized to determine the effect of awake prone positioning on intubation for invasive ventilation––patients are eligible in case of acute hypoxemic respiratory failure without restrictions regarding etiology. The PRONELIFE study is a pragmatic trial in which blinding is impossible––however, as around 35 ICUs worldwide will participate in this study, its findings will be highly generalizable. The findings of the PRONELIFE study has the potential to change clinical management of patients who may need invasive ventilation because of acute hypoxemic respiratory failure.Trial registrationISRCTN, ISRCTN11536318. Registered 17 September 2021, https://www.isrctn.com/ISRCTN11536318The PRONELIFE study is registered at clinicaltrials.gov with reference number NCT04142736 (October, 2019).

scholarly journals Awake prone positioning in patients with hypoxemic respiratory failure due to COVID-19: the PROFLO multicenter randomized clinical trial

Critical Care ◽  
2021 ◽  
Vol 25 (1) ◽  
Author(s):  
Jacob Rosén ◽  
Erik von Oelreich ◽  
Diddi Fors ◽  
Malin Jonsson Fagerlund ◽  
Knut Taxbro ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Respiratory Failure ◽  
Randomized Clinical Trial ◽  
Noninvasive Ventilation ◽  
Standard Care ◽  
Group Versus ◽  
Organ Support ◽  
Control Group ◽  
Prone Positioning ◽  
Hypoxemic Respiratory Failure

Abstract Background The effect of awake prone positioning on intubation rates is not established. The aim of this trial was to investigate if a protocol for awake prone positioning reduces the rate of endotracheal intubation compared with standard care among patients with moderate to severe hypoxemic respiratory failure due to COVID-19. Methods We conducted a multicenter randomized clinical trial. Adult patients with confirmed COVID-19, high-flow nasal oxygen or noninvasive ventilation for respiratory support and a PaO2/FiO2 ratio ≤ 20 kPa were randomly assigned to a protocol targeting 16 h prone positioning per day or standard care. The primary endpoint was intubation within 30 days. Secondary endpoints included duration of awake prone positioning, 30-day mortality, ventilator-free days, hospital and intensive care unit length of stay, use of noninvasive ventilation, organ support and adverse events. The trial was terminated early due to futility. Results Of 141 patients assessed for eligibility, 75 were randomized of whom 39 were allocated to the control group and 36 to the prone group. Within 30 days after enrollment, 13 patients (33%) were intubated in the control group versus 12 patients (33%) in the prone group (HR 1.01 (95% CI 0.46–2.21), P = 0.99). Median prone duration was 3.4 h [IQR 1.8–8.4] in the control group compared with 9.0 h per day [IQR 4.4–10.6] in the prone group (P = 0.014). Nine patients (23%) in the control group had pressure sores compared with two patients (6%) in the prone group (difference − 18% (95% CI − 2 to − 33%); P = 0.032). There were no other differences in secondary outcomes between groups. Conclusions The implemented protocol for awake prone positioning increased duration of prone positioning, but did not reduce the rate of intubation in patients with hypoxemic respiratory failure due to COVID-19 compared to standard care. Trial registration ISRCTN54917435. Registered 15 June 2020 (https://doi.org/10.1186/ISRCTN54917435).

scholarly journals 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

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.

scholarly journals High-flow nasal oxygen reduces endotracheal intubation: a randomized clinical trial

2020 ◽  
Vol 14 ◽  
pp. 175346662095645
Author(s):  
Ricardo Andino ◽  
Gema Vega ◽  
Sandra Karina Pacheco ◽  
Nuria Arevalillo ◽  
Ana Leal ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Respiratory Failure ◽  
Endotracheal Intubation ◽  
Oxygen Therapy ◽  
High Flow ◽  
Hospital Length Of Stay ◽  
Control Group ◽  
Number Needed To Treat ◽  
Hypoxemic Respiratory Failure ◽  
Acute Hypoxemic Respiratory Failure

Background: The benefits of high-flow nasal cannula (HFNC) as primary intervention in patients with acute hypoxemic respiratory failure (AHRF) are still a matter in debate. Our objective was to compare HFNC therapy versus conventional oxygen therapy (COT) in the prevention of endotracheal intubation in this group of patients. Methods: An open-label, controlled and single-centre clinical trial was conducted in patients with severe AHRF, defined by a PaO2/FIO2 ratio ⩽200, to compare HFNC with a control group (CG) treated by COT delivered through a face mask, with the need to perform intubation as the primary outcome. The secondary outcomes included tolerance of the HFNC device and to look for the predictive factors for intubation in these patients. Results: A total of 46 patients were included (22 in the COT group and 24 in the HFNC group) 48% of whom needed intubation: 63% in the COT group and 33% in the HFNC group, with significant differences both in intention to treat [χ2 = 4.2; p = 0.04, relative risk (RR) = 0.5; confidence interval (CI) 95%: 0.3–1.0] and also in treatment analysis (χ2 = 4.7; p = 0.03; RR = 0.5; IC 95%: 0.3–0.9) We obtained a number needed to treat (NNT) = 3 patients treated to avoid an intubation. Intubation occurred significantly later in the HFNC group. Estimated PaO2/FIO2, respiratory rate and dyspnea were significantly better in the HFNC group. Patients treated with HFNC who required intubation presented significant worsening after the first 8 h, as compared with non-intubated HFNC group patients. Mortality was 22% with no differences. The HFNC group patients were hospitalized for almost half of the time in the intensive care unit (ICU) and in the ward, with significantly less hospital length of stay. A total of 14 patients in the HFNC group (58%) complained of excessive heat and 17% of noise; 3 patients did not tolerate HFNC. Conclusion: Patients with severe acute hypoxemic respiratory failure who tolerate HFNC present a significantly lower need for endotracheal intubation compared with conventional oxygen therapy. Clinical Trial Register EUDRA CT number: 2012-001671-36 The reviews of this paper are available via the supplemental material section.

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