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

NCT02112604 | Unknown

• 1 other identifier: 2010P001919B
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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

Keywords

critically ill, OSA, mechanical ventilation

Outcome Measures

Primary Outcomes (1)

• Apnea-hypopnea index (AHI)

  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).

  1 Night after extubation

Study Arms (1)

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

Interventions

Ventilator DEVICE

Mechanical ventilator used to replace or assist spontaneous breathing.

Ventilated patients

Alice PDx DEVICE

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.

Ventilated patients

Pulmonary function test OTHER

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

Ventilated patients

Muscle strength tests OTHER

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

Ventilated patients

Grip strength measurement OTHER

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.

Ventilated patients

Sedatives and muscle relaxants given in the ICU DRUG

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.

Ventilated patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Ventilated patients in the surgical intensive unit (SICU)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Related Publications (2)

• Mirzakhani H, Williams JN, Mello J, Joseph S, Meyer MJ, Waak K, Schmidt U, Kelly E, Eikermann M. Muscle weakness predicts pharyngeal dysfunction and symptomatic aspiration in long-term ventilated patients. Anesthesiology. 2013 Aug;119(2):389-97. doi: 10.1097/ALN.0b013e31829373fe.

  PMID: 23584384 BACKGROUND

• Timm FP, Zaremba S, Grabitz SD, Farhan HN, Zaremba S, Siliski E, Shin CH, Muse S, Friedrich S, Mojica JE, Kurth T, Ramachandran SK, Eikermann M. Effects of Opioids Given to Facilitate Mechanical Ventilation on Sleep Apnea After Extubation in the Intensive Care Unit. Sleep. 2018 Jan 1;41(1). doi: 10.1093/sleep/zsx191.

  PMID: 29182729 DERIVED

MeSH Terms

Conditions

Critical Illness; Sleep Apnea, Obstructive

Interventions

Ventilators, Mechanical; Respiratory Physiological Phenomena; Hypnotics and Sedatives

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Equipment and Supplies; Circulatory and Respiratory Physiological Phenomena; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Central Nervous System Agents; Therapeutic Uses

Study Officials

• Matthias Eikermann, MD, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Matthias Eikermann, MD, PhD

CONTACT

617-643-4408; MEIKERMANN@PARTNERS.ORG

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Research, Critical Care Division; Associate Professor of Anaesthesia, Harvard Medical School

Study Record Dates

• First Submitted: April 10, 2014
• First Posted: April 14, 2014
• Study Start: July 1, 2011
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: March 17, 2016

Record last verified: 2016-03

Locations

US (1)