Effects Of Invasive And Noninvasive Mechanical Ventilation On Sleep In The Intensive Care Unit (ICU)
Completed
Conditions studied: Respiratory Insufficiency, Respiration, Artificial, Sleep Deprivation
In brief
The purpose of this study is to monitor sleep in patients using breathing machines, because little is known about sleep when patients use masks to help their breathing. We'd like to compare sleep in patients using masks to that in patients with a tube in their throats.
Key facts
- Study ID
- NCT00638339
- Run by
- Tufts Medical Center
- People needed
- 16
- Starts
- 2006-11-01
- Expected to finish
- 2017-03-01
- Last updated by the study team
- 2019-08-06
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age > 18 yrs
- Receiving invasive or noninvasive mechanical ventilation
- Anticipated further ventilation of at least 24-hour duration for IMV and 8 hours/ 24 hours for NIV
You may not qualify if…
- Pre-morbid diseases that could interfere with interpretation of sleep monitoring including CNS disorders (strokes, encephalopathic states), dementia, and known sleep disorders
- On home BiPAP or CPAP
- Depressed sensorium as evidence by Glasgow Coma Score < 10, need for continuous sedation with Riker Score < 2 and inability to follow verbal commands for sustained 3 hours
- Presence of head trauma, psychiatric illness (including use of antidepressant medication), anoxic brain injury, drug overdose or uncontrolled seizure disorder
- Severe hemodynamic instability (BP< 90 mmHg despite vasopressor therapy) and sepsis
- Recalcitrant hypoxemia (inability to sustain SaO2 > 88%)
- Considered as unstable by ICU team (hemodynamic instability, acute uncontrolled GI bleeding, acute cardiac ischemia or arrhythmias)
Where it is running
- Tufts-New England Medical Center Medical ICU and Coronary Care Unit — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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