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Completed

NCT Number: NCT01410149

Sleep Quality in Mechanically Ventilated Patients

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.

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Key information

Conditions

Respiratory Failure Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

London Health Sciences Centre - University Hospital

London, Ontario, N6A 5A5, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PAV

Other

Proportional Assist Ventilation will be used to ventilate the patient for a 24 hour period

PSV

Other

Pressure Support Ventilation will be used to ventilate the patient for a 24 hour period

ACV

Other

Assist Control Ventilation will be used to ventilate the patient for a 24 hour period

Primary outcomes

  1. 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)

Secondary outcomes

  1. Patient-ventilator asynchrony

    Time frame: 3 nights

    Incidence of patient-ventilator asynchrony (asynchrony index, % of asynchronous breaths per minute)

Other outcomes

  1. Delirium

    Time frame: 3 days

    Positive score on a delirium screening tool (CAM-ICU or ICDSC)

  2. 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. 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

  4. Blood gas

    Time frame: evening and morning

    measurement of paO2 and paCO2

Sponsors and collaborators

Lead sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Other

Collaborators

  • Medtronic - MITG
  • Ontario Lung Association

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2010
Study completion
2011
First posted
Aug 4, 2011
Registry last updated
Aug 15, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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