CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 44 enrolled
Drug / intervention
Polysomnographydevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02464735
NCT02464735N/ACompleted

Effect of Sleep Disruption on the Outcome of Weaning From Mechanical Ventilation

Unity Health Toronto·observational·Posted Jun 8, 2015·Updated Apr 12, 2018

In Brief

An observational study evaluating Polysomnography for Respiratory Insufficiency. Completed, enrolled 44 participants across 3 sites.

Detailed Summary

Mechanically ventilated patients in the Intensive Care Unit (ICU) are highly susceptible to sleep disruption. Several studies in the last 15 years have demonstrated an extremely poor sleep quality and abnormal sleep pattern evaluated by polysomnography (PSG) devices (the gold standard method for evaluating sleep quality and quantity). Discontinuation of mechanical ventilation should be considered as soon as possible when a patient's condition starts to improve. A patient's ability to be weaned from the mechanical ventilator can be assessed using two step approaches including a Rapid Shallow Breathing Index (RSBI) calculation then a spontaneous breathing trial (SBT) to determine the likelihood of success or failure before considering endotracheal extubation. The rate of weaning failure from the first SBT attempt has been reported to be 35-55%. The reason for weaning failure may be complex and multifactorial. An association between sleep disruption and weaning outcome has never been studied. The goal of this study is to look for an association between poor sleep quality and failure of a weaning attempt. This study is an observational, physiological study investigating sleep quality and quantity in patients who will be weaned by recording standard PSG (from 17:00 to 08:00) at night before a weaning attempt. Sleep characteristics of patients failing or passing the weaning attempt will be compared. In addition, we will compare sleep patterns before and after endotracheal extubation.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesCanada
Collaborators--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedJun 8, 2015
Enrollment StartJan 1, 2016
Primary CompletionSep 1, 2017
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 11.1 years ago

Interventions

Polysomnographydevice