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

Critically Ill research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Critically Ill

Obstructive Sleep Apnea

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Device:VentilatorMechanical ventilator used to replace or assist spontaneous breathing.

Device:Alice PDxAlice 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 testThe pulmonary function tests are used to study upper airway patency.

Other:Muscle strength testsMRC 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 measurementGrip 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 ICUPatients 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.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Ventilated patientsPatients 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

Study Status

Recruiting

Start Date: July 2011

Completed Date: December 2016

Phase: N/A

Type: Observational

Design:

Primary Outcome: Apnea-hypopnea index (AHI)

Secondary Outcome:

Study sponsors, principal investigator, and references

Principal Investigator: Matthias Eikermann, MD, PhD

Lead Sponsor: Massachusetts General Hospital

Collaborator:

More information:https://clinicaltrials.gov/show/NCT02112604

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.

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