Sleep Quality in Mechanically Ventilated Patients

This study has been completed.
Sponsor:
Collaborators:
Ontario Lung Association
Covidien
Information provided by (Responsible Party):
Karen Bosma, Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT01410149
First received: August 3, 2011
Last updated: August 13, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention
Respiratory Failure
Other: PAV
Other: PSV
Other: ACV

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Influence of Mode and Patient-ventilator Interaction on Sleep Quality in the ICU

Resource links provided by NLM:


Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:
  • Sleep quality [ Time Frame: 3 nights ] [ Designated as safety issue: No ]
    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:
  • Patient-ventilator asynchrony [ Time Frame: 3 nights ] [ Designated as safety issue: No ]
    Incidence of patient-ventilator asynchrony (asynchrony index, % of asynchronous breaths per minute)


Other Outcome Measures:
  • Delirium [ Time Frame: 3 days ] [ Designated as safety issue: No ]
    Positive score on a delirium screening tool (CAM-ICU or ICDSC)

  • Comfort [ Time Frame: 3 days ] [ Designated as safety issue: No ]
    Patient's assessment of their own breathing comfort and their perceived quality of sleep, indicated on a visual analogue scale

  • Respiratory pattern [ Time Frame: 3 nights ] [ Designated as safety issue: No ]
    Measurement of average tidal volume, respiratory rate, minute ventilation and non-invasive measurement of respiratory muscle effort relative to maximum effort

  • Blood gas [ Time Frame: evening and morning ] [ Designated as safety issue: No ]
    measurement of paO2 and paCO2


Enrollment: 13
Study Start Date: April 2007
Study Completion Date: December 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01410149

Locations
Canada, Ontario
London Health Sciences Centre - University Hospital
London, Ontario, Canada, N6A 5A5
Sponsors and Collaborators
Lawson Health Research Institute
Ontario Lung Association
Covidien
Investigators
Principal Investigator: Karen J. Bosma, MD, FRCPC Lawson Health Research Institute
  More Information

Publications:

Responsible Party: Karen Bosma, Principal Investigator, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT01410149     History of Changes
Other Study ID Numbers: R-07-106, 13114
Study First Received: August 3, 2011
Last Updated: August 13, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by Lawson Health Research Institute:
PAV (proportional assist ventilation); sleep; polysomnography; mechanical ventilation

Additional relevant MeSH terms:
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 17, 2014