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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 16, 2014