Sleep Quality in Mechanically Ventilated Patients

Study Overview
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Brief Summary
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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.

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

Conditions
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Respiratory Failure

Intervention / Treatment
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* Other: PAV
* Other: PSV
* Other: ACV


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PAV<br>Proportional Assist Ventilation (PAV+ on PB840 ventilator) | Other: PAV<br>* Proportional Assist Ventilation will be used to ventilate the patient for a 24 hour period<br>|
| Active Comparator: PSV<br>Pressure Support Ventilation (PSV on PB840 ventilator) | Other: PSV<br>* Pressure Support Ventilation will be used to ventilate the patient for a 24 hour period<br>|
| Active Comparator: ACV<br>Assist Control/ Pressure limited Ventilation (on PB840 ventilator) | Other: ACV<br>* Assist Control Ventilation will be used to ventilate the patient for a 24 hour period<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep quality | Sleep fragmentation (number of arousals and awakenings/hr sleep), sleep architecture (% time asleep spent in Stage 1, 2, 3/4 and REM sleep) | 3 nights | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-ventilator asynchrony | Incidence of patient-ventilator asynchrony (asynchrony index, % of asynchronous breaths per minute) | 3 nights | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PAV (proportional assist ventilation); sleep; polysomnography; mechanical ventilation