Respiratory Failure
Conditions
Keywords
PAV (proportional assist ventilation); sleep; polysomnography; mechanical ventilation
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.
Interventions
Sponsors
Ontario Lung Association
Medtronic - MITG
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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 * sepsis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sleep quality | 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
| Measure | Time frame | Description |
|---|---|---|
| Patient-ventilator asynchrony | 3 nights | Incidence of patient-ventilator asynchrony (asynchrony index, % of asynchronous breaths per minute) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Delirium | 3 days | Positive score on a delirium screening tool (CAM-ICU or ICDSC) |
| Comfort | 3 days | Patient's assessment of their own breathing comfort and their perceived quality of sleep, indicated on a visual analogue scale |
| Respiratory pattern | 3 nights | Measurement of average tidal volume, respiratory rate, minute ventilation and non-invasive measurement of respiratory muscle effort relative to maximum effort |
| Blood gas | evening and morning | measurement of paO2 and paCO2 |
Countries
Canada
Outcome results
None listed