Sleep Quality in Mechanically Ventilated Patients

Not Applicable

Completed

• Conditions: Respiratory Failure
• Interventions: Other: PAV; Other: PSV; Other: ACV

• Registration Number: NCT01410149
• Lead Sponsor: Lawson Health Research Institute

Brief Summary

Patients requiring mechanical ventilation in the ICU will undergo three consecutive nights of polysomnography to record sleep patterns while receiving three modes of mechanical ventilation; Proportional assist ventilation (PAV), Pressure support ventilation (PSV), Assist control ventilation (ACV), applied in random order. The purpose is to determine the effect of mode of mechanical ventilation on patient-ventilator asynchrony and sleep quality.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-04
• Primary Completion: 2010-12
• Study First Submitted: 2011-08-03
• Study First Submitted QC: 2011-08-03
• Study First Posted: 2011-08-04
• Study Completion: 2011-12
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-13
• Last Update Posted: 2012-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

• Age 18-75
• received mechanical ventilation >72 hours
• glasgow coma scale >10
• acute physiology score <13
• ready for partial ventilatory support: intact respiratory drive, PaO2/FiO2 ratio >200 on positive end expiratory pressure (PEEP) less than or equal to 5 cmH2O, and PH of 7.35 to 7.45
• sedation: analgesia at dose not higher than 0.01 mg/kg/hr morphine equivalent x 48 hours, sedation at dose not higher than 0.01 mg/kg/hr lorazepam equivalent x 72 hours.
• anticipate ongoing need for partial ventilatory support for the following 72 hours

Exclusion Criteria

• Successful completion of spontaneous breathing trial
• Neurological injury, encephalopathy or abnormal EEG
• History of central sleep apnea
• General anaesthesia within 72 hours from study entry
• Requiring haloperidol >10 mg/24 hours
• hemodynamically unstable
• sepsis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
PAV	PAV	Proportional Assist Ventilation (PAV+ on PB840 ventilator)
PSV	PSV	Pressure Support Ventilation (PSV on PB840 ventilator)
ACV	ACV	Assist Control/ Pressure limited Ventilation (on PB840 ventilator)

Primary Outcome Measures

Name	Time	Method
Sleep quality	3 nights	Sleep fragmentation (number of arousals and awakenings/hr sleep), sleep architecture (% time asleep spent in Stage 1, 2, 3/4 and REM sleep)

Secondary Outcome Measures

Name	Time	Method
Patient-ventilator asynchrony	3 nights	Incidence of patient-ventilator asynchrony (asynchrony index, % of asynchronous breaths per minute)

Trial Locations

Locations (1)

London Health Sciences Centre - University Hospital; 🇨🇦 London, Ontario, Canada