Sleep Quality in Mechanically Ventilated Patients

August 13, 2012 updated by: Karen Bosma, Lawson Health Research Institute

The Influence of Mode and Patient-ventilator Interaction on Sleep Quality in the ICU

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada, N6A 5A5
        • London Health Sciences Centre - University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: PAV
Proportional Assist Ventilation (PAV+ on PB840 ventilator)
Other: PAV
Proportional Assist Ventilation will be used to ventilate the patient for a 24 hour period
Active Comparator: PSV
Pressure Support Ventilation (PSV on PB840 ventilator)
Other: PSV
Pressure Support Ventilation will be used to ventilate the patient for a 24 hour period
Active Comparator: ACV
Assist Control/ Pressure limited Ventilation (on PB840 ventilator)
Other: ACV
Assist Control Ventilation will be used to ventilate the patient for a 24 hour period

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sleep quality
Time Frame: 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)
3 nights

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient-ventilator asynchrony
Time Frame: 3 nights
Incidence of patient-ventilator asynchrony (asynchrony index, % of asynchronous breaths per minute)
3 nights

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Delirium
Time Frame: 3 days
Positive score on a delirium screening tool (CAM-ICU or ICDSC)
3 days
Comfort
Time Frame: 3 days
Patient's assessment of their own breathing comfort and their perceived quality of sleep, indicated on a visual analogue scale
3 days
Respiratory pattern
Time Frame: 3 nights
Measurement of average tidal volume, respiratory rate, minute ventilation and non-invasive measurement of respiratory muscle effort relative to maximum effort
3 nights
Blood gas
Time Frame: evening and morning
measurement of paO2 and paCO2
evening and morning

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lawson Health Research Institute

Collaborators

Medtronic - MITG
Ontario Lung Association

Investigators

  • Principal Investigator: Karen J. Bosma, MD, FRCPC, Lawson Health Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

August 3, 2011

First Submitted That Met QC Criteria

August 3, 2011

First Posted (Estimate)

August 4, 2011

Study Record Updates

Last Update Posted (Estimate)

August 15, 2012

Last Update Submitted That Met QC Criteria

August 13, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R-07-106
  • 13114 (REB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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