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

NCT02464735 | Completed

• 1 other identifier: REB# 15-142
• Study Type: observational
• Target: 44
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Respiratory Insufficiency

Keywords

Sleep disruption; Spontaneous breathing trial; Weaning

Outcome Measures

Primary Outcomes (2)

• Comparison of sleep quality between patients who pass weaning and patients who fail a weaning assessment

  15 hours

• Comparison of sleep quality (sleep efficiency and fragmentation) the night before a patient fails weaning and the night after they eventually pass weaning

  30 hours

Secondary Outcomes (5)

• Comparison between patients who pass and patients who fail weaning in terms of % of rapid eye movement sleep, sleep quantity (or efficiency), slow wave sleep and circadian sleep ratio, % of "pathological/atypical" sleep patterns, and sleep continuity

  15 hours

• Comparison of sleep architecture (total sleep time, % of NREM and REM sleep) the night before weaning and the night of extubation

  30 hours

• Incidence of delirium amongst all patient groups, regardless of the outcome of weaning

  Up to 14 days

• Analysis of the validity of the odds ratio product (ORP) technique for classification of sleep depth in comparison to standard PSG criteria by American Academy of Sleep Medicine (AASM).

  Up to 14 days

• Correlation between sleep disruption and delirium.

  Up to 14 days

Interventions

Polysomnography DEVICE

Eligibility Criteria

• Age: 17 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Mechanically ventilated Intensive Care Unit patients who have a spontaneous breathing trial planned for the next day.

You may qualify if:

• Age \> 16 years
• Intubated and mechanically ventilated
• A spontaneous breathing trial (SBT) is planned for the next day; patients can be enrolled if they have already had previous SBTs

You may not qualify if:

• Presence of recent major central nervous system disease impairing consciousness with Glasgow Coma Scale ≤ 8T
• Patients with a sleep breathing disorder when it is predominantly central sleep apnea; patients with predominantly obstructive sleep apnea can be included

Sponsors & Collaborators

• Unity Health Toronto: lead

Study Sites (3)

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

Location

Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

Location

Related Publications (4)

• Drouot X, Cabello B, d'Ortho MP, Brochard L. Sleep in the intensive care unit. Sleep Med Rev. 2008 Oct;12(5):391-403. doi: 10.1016/j.smrv.2007.11.004. Epub 2008 May 23.

  PMID: 18502155 BACKGROUND

• Roche Campo F, Drouot X, Thille AW, Galia F, Cabello B, d'Ortho MP, Brochard L. Poor sleep quality is associated with late noninvasive ventilation failure in patients with acute hypercapnic respiratory failure. Crit Care Med. 2010 Feb;38(2):477-85. doi: 10.1097/CCM.0b013e3181bc8243.

  PMID: 19789439 BACKGROUND

• Tobin MJ. Extubation and the myth of "minimal ventilator settings". Am J Respir Crit Care Med. 2012 Feb 15;185(4):349-50. doi: 10.1164/rccm.201201-0050ED. No abstract available.

  PMID: 22336673 BACKGROUND

• Boles JM, Bion J, Connors A, Herridge M, Marsh B, Melot C, Pearl R, Silverman H, Stanchina M, Vieillard-Baron A, Welte T. Weaning from mechanical ventilation. Eur Respir J. 2007 May;29(5):1033-56. doi: 10.1183/09031936.00010206.

  PMID: 17470624 BACKGROUND

MeSH Terms

Conditions

Respiratory Insufficiency

Interventions

Polysomnography

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Monitoring, Physiologic; Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2015
• First Posted: June 8, 2015
• Study Start: January 1, 2016
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: April 12, 2018

Record last verified: 2018-04

Locations

CA (3)