Predictors of Upper Airway Function and Sleep-disordered Breathing in the Critically Ill
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|ClinicalTrials.gov Identifier: NCT02112604|
Recruitment Status : Recruiting
First Posted : April 14, 2014
Last Update Posted : March 17, 2016
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.
|Condition or disease||Intervention/treatment|
|Critically Ill Obstructive Sleep Apnea||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|
|Study Type :||Observational|
|Estimated Enrollment :||50 participants|
|Official Title:||Determining Predictors of Adequate Upper Airway Function in Ventilated Patients|
|Study Start Date :||July 2011|
|Estimated Primary Completion Date :||December 2016|
|Estimated Study Completion Date :||December 2016|
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
Mechanical ventilator used to replace or assist spontaneous breathing.Device: Alice PDx
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.Other: Pulmonary function test
The pulmonary function tests are used to study upper airway patency.Other: Muscle strength tests
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 measurementOther: Grip strength measurement
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.Drug: Sedatives and muscle relaxants given in the ICU
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.
- Apnea-hypopnea index (AHI) [ Time Frame: 1 Night after extubation ]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).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02112604
|Contact: Matthias Eikermann, MD, PhD||617-643-4408||MEIKERMANN@PARTNERS.ORG|
|United States, Massachusetts|
|Massachusetts General Hospital||Recruiting|
|Boston, Massachusetts, United States, 02114|
|Contact: Matthias Eikermann, MD, PhD 617-643-4408 MEIKERMANN@PARTNERS.ORG|
|Principal Investigator: Matthias Eikermann, MD, PhD|
|Principal Investigator:||Matthias Eikermann, MD, PhD||Massachusetts General Hospital|