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

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Mass General Brigham

Status

Unknown

Conditions

Critically Ill
Obstructive Sleep Apnea

Treatments

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

Study type

Observational

Funder types

Other

Identifiers

NCT02112604
2010P001919B

Details and patient eligibility

About

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.

Enrollment

50 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

50 participants in 1 patient group

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

Trial contacts and locations

1

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Central trial contact

Matthias Eikermann, MD, PhD

Data sourced from clinicaltrials.gov

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