Critically Ill, Obstructive Sleep Apnea
Conditions
Keywords
critically ill, OSA, mechanical ventilation
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.
Interventions
DEVICEVentilator
Mechanical ventilator used to replace or assist spontaneous breathing.
DEVICEAlice 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.
OTHERPulmonary function test
The pulmonary function tests are used to study upper airway patency.
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 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.
DRUGSedatives 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.
Sponsors
Massachusetts General Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Apnea-hypopnea index (AHI) | 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). |
Countries
United States
Contacts
Primary ContactMatthias Eikermann, MD, PhD
Outcome results
None listed