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

NCT02112604 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2016-03-17

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Matthias Eikermann, MD, PhD · Massachusetts General Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2016-12-31
Completion
2016-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02112604 on ClinicalTrials.gov