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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Massachusetts General Hospital
Sponsor:
Information provided by (Responsible Party):
Matthias Eikermann, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT02112604
First received: April 10, 2014
Last updated: April 11, 2014
Last verified: April 2014
  Purpose

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 Intervention
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
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Determining Predictors of Adequate Upper Airway Function in Ventilated Patients

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Apnea-hypopnea index (AHI) [ Time Frame: 1 Night after extubation ] [ Designated as safety issue: No ]
    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).


Estimated Enrollment: 50
Study Start Date: July 2011
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Ventilated patients in the surgical intensive unit (SICU)

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02112604

Contacts
Contact: Matthias Eikermann, MD, PhD 617-643-4408 MEIKERMANN@PARTNERS.ORG

Locations
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
Investigators
Principal Investigator: Matthias Eikermann, MD, PhD Massachusetts General Hospital
  More Information

Publications:
Responsible Party: Matthias Eikermann, Director of Research, Critical Care Division; Associate Professor of Anaesthesia, Harvard Medical School, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02112604     History of Changes
Other Study ID Numbers: 2010P001919B
Study First Received: April 10, 2014
Last Updated: April 11, 2014
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on July 23, 2014