The Influence of Mode and Patient-ventilator Interaction on Sleep Quality in the ICU
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 13
- Locations
- 1
- Primary Endpoint
- Sleep quality
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
PAV
Proportional Assist Ventilation (PAV+ on PB840 ventilator)
Intervention: PAV (Other)
ACV
Assist Control/ Pressure limited Ventilation (on PB840 ventilator)
Intervention: ACV (Other)
PSV
Pressure Support Ventilation (PSV on PB840 ventilator)
Intervention: PSV (Other)
Outcomes
Primary Outcomes
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
- Patient-ventilator asynchrony(3 nights)
Investigators
Karen Bosma
Principal Investigator
Lawson Health Research Institute