Recruiting

Observational Study

Sponsor:

Massachusetts General Hospital

Code:

NCT02112604

Conditions

Critically Ill

Obstructive Sleep Apnea

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Ventilator

Alice PDx

Pulmonary function test

Muscle strength tests

Grip strength measurement

Study Details

Brief 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

Study ID

NCT02112604

Start date

Jul, 2011

Status verified date

Mar, 2016

Completion date

Dec, 2016

Anticipated

Primary completion date

Dec, 2016

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Patients admitted to the SICU
2. Age over 18 years.
3. Ventilated patients with an endotracheal tube for at least 24 hours.

Exclusion Criteria:

1. Decreased level of consciousness as defined by a Richmond Agitation Sedation Scale (RASS) of 0.
2. Non-cooperative patient, CAM score positive for risk of delirium.
3. For women: pregnancy.

Study Design

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Arms

Ventilated patients

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

Interventions

Ventilator

Mechanical ventilator used to replace or assist spontaneous breathing.

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.

Pulmonary function test

The pulmonary function tests are used to study upper airway patency.

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

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.

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.

Primary outcome measure

  • Apnea-hypopnea index (AHI) [ Time Frame: 1 Night after extubation ]

Central Contacts and Locations

Central contacts

Matthias Eikermann, MD, PhD

617-643-4408MEIKERMANN@PARTNERS.ORG

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Matthias Eikermann, MD, PhD

617-643-4408MEIKERMANN@PARTNERS.ORG

Principal Investigator:

Matthias Eikermann, MD, PhD

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Mar 17, 2016

Last verified

Mar, 2016

Keywords

  • critically ill, OSA, mechanical ventilation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2016-03-17.