Status:
COMPLETED
Effects Of Invasive And Noninvasive Mechanical Ventilation On Sleep In The Intensive Care Unit (ICU)
Lead Sponsor:
Tufts Medical Center
Conditions:
Respiratory Insufficiency
Respiration, Artificial
Eligibility:
All Genders
18+ years
Brief Summary
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 p...
Detailed Description
Sleep in critically-ill patients is commonly severely fragmented, and sleep architecture is altered as compared to a healthy person. This abnormal sleep may cause some important adverse psychological ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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)
Key Trial Info
Start Date :
November 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2017
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00638339
Start Date
November 1 2006
End Date
March 1 2017
Last Update
August 6 2019
Active Locations (1)
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1
Tufts-New England Medical Center Medical ICU and Coronary Care Unit
Boston, Massachusetts, United States, 02111