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

Obstructive Sleep Apnea Clinical Trial

Official title:

Determining Predictors of Adequate Upper Airway Function in Ventilated Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02112604
• Other study ID #: 2010P001919B
• Status: Recruiting
• Phase: N/A
• First received: April 10, 2014
• Last updated: March 16, 2016
• Start date: July 2011
• Est. completion date: December 2016

Study information

• Verified date: March 2016
• Source: Massachusetts General Hospital
• Contact: Matthias Eikermann, MD, PhD
• Phone: 617-643-4408
• Email: MEIKERMANN[@]PARTNERS.ORG
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Critical Illness
• Critically Ill
• Obstructive Sleep Apnea
• Sleep Apnea, Obstructive

Intervention

Device:
• 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.

Other:
• 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.

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.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No