Predictors of Upper Airway Function and Sleep-disordered Breathing in the Critically Ill

Study Overview
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Brief Summary
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This is part 2 of the #NCT01618240 under the same IRB protocol #2010P001919. The primary objective of this study is to examine factors that are related to sleep-disordered breathing and upper airway patency in critically ill patients who have been recently mechanically ventilated. Our primary hypothesize is that sedatives and neuromuscular blocking agents given in the ICU prior to extubation and during the first night following extubation are associated with sleep-disordered breathing. The secondary hypotheses are that duration of mechanical ventilation, BMI, and muscle strength are associated with sleep-disordered breathing during the night after extubation. The secondary objective is to evaluate if sleep-disordered breathing in the ICU can be predicted by standard pulmonary function testing in the ICU.

Official Title
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Determining Predictors of Adequate Upper Airway Function in Ventilated Patients

Conditions
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Critically Ill, Obstructive Sleep Apnea

Intervention / Treatment
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* Device: Ventilator
* Device: Alice PDx
* Other: Pulmonary function test
* Other: Muscle strength tests
* Other: Grip strength measurement
* Drug: Sedatives and muscle relaxants given in the ICU


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients admitted to the SICU Age over 18 years. Ventilated patients with an endotracheal tube for at least 24 hours. Exclusion Criteria: Decreased level of consciousness as defined by a Richmond Agitation Sedation Scale (RASS) of 0. Non-cooperative patient, CAM score positive for risk of delirium. For women: pregnancy.

Ages Eligible for Study
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Minimum Age: 18 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ventilated patients<br>Patients who have been extubated within 24 hours and have been mechanically ventilated for at least 24 hours. Alice PDx, pulmonary function tests, muscle strength tests, grip strength measurements, ventilator, Sedatives and muscle relaxants given in the ICU | Device: Ventilator<br>* Mechanical ventilator used to replace or assist spontaneous breathing.<br>Device: Alice PDx<br>* Alice PDx is a polysomnography monitor used to study stages of sleep and detect sleep-disordered breathing. The device monitors PO2, airflow, EEG, EOG and abdominal wall movements to detect sleep apnea.<br>Other: Pulmonary function test<br>* The pulmonary function tests are used to study upper airway patency.<br>Other: Muscle strength tests<br>* MRC score (0-60) is a clinical assessment of muscle power on abduction of the arm, flexion of the forearm, extension of the wrist, flexion of the leg, extension of the knee and dorsal flexion of the foot with the score of (0-5) on each measurement<br>Other: Grip strength measurement<br>* Grip strength has been shown to be an accurate means of assessing muscle function in the critically ill. Muscle weakness may have an impact on upper airway patency.<br>Drug: Sedatives and muscle relaxants given in the ICU<br>* Patients in the ICU are administered sedatives, anesthetics, opiods, anti-pyschotics and neuromuscular blocking agents as part of routine care. We hypothesize that the use of these drugs is associated with sleep-disordered breathing following extubation. We will collect the drug doses from the patient's chart.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Apnea-hypopnea index (AHI) | The apnea-hypopnea index (AHI) is calculated the night after extubation via a polysomnography device. An AHI ≥ 5 indicates sleep-disordered breathing and obstructive sleep apnea (OSA). | 1 Night after extubation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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critically ill, OSA, mechanical ventilation