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

BMJ Open ◽  
2019 ◽  
Vol 9 (7) ◽  
pp. e029394 ◽  
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.

scholarly journals Early rehabilitation relieves diaphragm dysfunction induced by prolonged mechanical ventilation: a randomised control study

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Zehua Dong ◽  
Ying Liu ◽  
Yubiao Gai ◽  
Pingping Meng ◽  
Hui Lin ◽  
...  
Keyword(s):  
Mechanical Ventilation ◽  
Prolonged Mechanical Ventilation ◽  
Controlled Trial ◽  
Early Rehabilitation ◽  
Control Group ◽  
Clinical Trial Registry ◽  
Diaphragm Dysfunction ◽  
Mechanically Ventilated ◽  
Rehabilitation Therapy ◽  
Randomised Controlled

Abstract Background Prolonged mechanical ventilation (MV) induces diaphragm dysfunction in patients in the intensive care units (ICUs). Our study aimed to explore the therapeutic efficacy of early rehabilitation therapy in patients with prolonged MV in the ICU. Methods Eighty eligible patients who underwent MV for > 72 h in the ICU from June 2019 to March 2020 were enrolled in this prospective randomised controlled trial. The patients were randomly divided into a rehabilitation group (n = 39) and a control group (n = 41). Rehabilitation therapy included six levels of rehabilitation exercises. Diaphragm function was determined using ultrasound (US). Results Diaphragmatic excursion (DE) and diaphragm thickening fraction (DTF) were significantly decreased in all patients in both groups after prolonged MV (p < 0.001). The rehabilitation group had significantly higher DTF (p = 0.008) and a smaller decrease in DTF (p = 0.026) than the control group after 3 days of rehabilitation training. The ventilator duration and intubation duration were significantly shorter in the rehabilitation group than in the control group (p = 0.045 and p = 0.037, respectively). There were no significant differences in the duration of ICU stay, proportion of patients undergoing tracheotomy, and proportion of recovered patients between the two groups. Conclusions Early rehabilitation is feasible and beneficial to ameliorate diaphragm dysfunction induced by prolonged MV and advance withdrawal from the ventilator and extubation in patients with MV. Diaphragm US is suggested for mechanically ventilated patients in the ICU. Trial registration Chinese Clinical Trial Registry, ID: ChiCTR1900024046, registered on 2019/06/23.

Effect of Early versus Late Tracheostomy Placement on Survival in Patients Receiving Mechanical Ventilation

2018 ◽  
pp. 157-162
Author(s):  
J. Michael Guthrie ◽  
Vadim Gudzenko
Keyword(s):  
Mechanical Ventilation ◽  
Prolonged Mechanical Ventilation ◽  
Controlled Trial ◽  
Hospital Length ◽  
Hospital Length Of Stay ◽  
Icu Patients ◽  
Early Tracheostomy ◽  
Mechanically Ventilated ◽  
Study Intervention

The TracMan randomized controlled trial examined mortality among patients randomized to receive early (first 4 days) versus late (after 10 days) tracheostomy. This chapter describes the basics of the study, including funding, study location, who was studied, how many patients, study design, study intervention, follow-up, endpoints, results, and criticism and limitations. It briefly reviews other relevant studies and information, discusses implications, and concludes with a relevant clinical case. The study found that early tracheostomy did not improve mortality in mechanically ventilated ICU patients. Early tracheostomy did not improve important patient outcomes such as ICU or hospital length of stay. The study also demonstrated that clinicians’ ability to predict which ICU patients will require prolonged mechanical ventilation is severely limited.

scholarly journals Preemptive ganciclovir for mechanically ventilated patients with cytomegalovirus reactivation

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Laurent Papazian ◽  
◽  
Samir Jaber ◽  
Sami Hraiech ◽  
Karine Baumstarck ◽  
...  
Keyword(s):  
Mechanical Ventilation ◽  
Invasive Mechanical Ventilation ◽  
Double Blind ◽  
Intravenous Ganciclovir ◽  
Subdistribution Hazard ◽  
Mechanically Ventilated ◽  
Cytomegalovirus Reactivation ◽  
Secondary Outcomes ◽  
To Receive ◽  
Cmv Reactivation

Abstract Background The effect of cytomegalovirus (CMV) reactivation on the length of mechanical ventilation and mortality in immunocompetent ICU patients requiring invasive mechanical ventilation remains controversial. The main objective of this study was to determine whether preemptive intravenous ganciclovir increases the number of ventilator-free days in patients with CMV blood reactivation. Methods This double-blind, placebo-controlled, randomized clinical trial involved 19 ICUs in France. Seventy-six adults ≥ 18 years old who had been mechanically ventilated for at least 96 h, expected to remain on mechanical ventilation for ≥ 48 h, and exhibited reactivation of CMV in blood were enrolled between February 5th, 2014, and January 23rd, 2019. Participants were randomized to receive ganciclovir 5 mg/kg bid for 14 days (n = 39) or a matching placebo (n = 37). Results The primary endpoint was ventilator-free days from randomization to day 60. Prespecified secondary outcomes included day 60 mortality. The trial was stopped for futility based on the results of an interim analysis by the DSMB. The subdistribution hazard ratio for being alive and weaned from mechanical ventilation at day 60 for patients receiving ganciclovir (N = 39) compared with control patients (N = 37) was 1.14 (95% CI from 0.63 to 2.06; P = 0.66). The median [IQR] numbers of ventilator-free days for ganciclovir-treated patients and controls were 10 [0–51] and 0 [0–43] days, respectively (P = 0.46). Mortality at day 60 was 41% in patients in the ganciclovir group and 43% in the placebo group (P = .845). Creatinine levels and blood cells counts did not differ significantly between the two groups. Conclusions In patients mechanically ventilated for ≥ 96 h with CMV reactivation in blood, preemptive ganciclovir did not improve the outcome.

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