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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02112604
Recruitment Status : Unknown
Verified March 2016 by Matthias Eikermann, Massachusetts General Hospital.
Recruitment status was:  Recruiting
First Posted : April 14, 2014
Last Update Posted : March 17, 2016
Information provided by (Responsible Party):
Matthias Eikermann, Massachusetts General Hospital

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.

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
Observational Model: Cohort
Time Perspective: Prospective
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

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Group/Cohort Intervention/treatment
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
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.

Primary Outcome Measures :
  1. 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).

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Ventilated patients in the surgical intensive unit (SICU)

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.

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its 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         
Sponsors and Collaborators
Massachusetts General Hospital
Principal Investigator: Matthias Eikermann, MD, PhD Massachusetts General Hospital

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Matthias Eikermann, Director of Research, Critical Care Division; Associate Professor of Anaesthesia, Harvard Medical School, Massachusetts General Hospital Identifier: NCT02112604     History of Changes
Other Study ID Numbers: 2010P001919B
First Posted: April 14, 2014    Key Record Dates
Last Update Posted: March 17, 2016
Last Verified: March 2016

Keywords provided by Matthias Eikermann, Massachusetts General Hospital:
critically ill, OSA, mechanical ventilation

Additional relevant MeSH terms:
Sleep Apnea, Obstructive
Critical Illness
Sleep Apnea Syndromes
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases
Disease Attributes
Pathologic Processes
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs