NCT02112604

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

Determining Predictors of Adequate Upper Airway Function in Ventilated Patients

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Critically Ill
• Obstructive Sleep Apnea

Interventions

Type	Name	Description
DEVICE	Ventilator	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 measurement
OTHER	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.

Timeline

• Start date: 2011-07-01
• Primary completion: 2016-12-01
• Completion: 2016-12-01
• First posted: 2014-04-14
• Last updated: 2016-03-17

Locations

1 site across 1 country: United States