Sedation in Patients at Risk for Upper Airway Collapse
Status:
Completed
Trial end date:
2008-10-01
Target enrollment:
Participant gender:
Summary
Overview of Protocol:
Between Subject - Repeated Measures design will be used to assess the airway response of two
groups of subjects under two different sedated conditions. Each group will be comprised of
six subjects and will be categorized according to their baseline profile for risk for SDB (<
10 RDI or > 25 RDI). Some subjects will have been prescribed continuous positive airway
pressure (CPAP) therapy by their treating physician as a result of their overnight sleep
study. CPAP treatment is effective in splinting the airway open and thus decreasing the
incident of airway collapse during sleep. Thus, CPAP utilization will also be tracked as an
independent and continuous variable as regular CPAP use has been found to be associated with
increased resistance to UAC (upper airway collapse).
The experimental conditions will evaluate upper airway patency and instability in response to
two forms of intravenous sedation: propofol and dexmedetomidine.
Subjects will be continuously monitored during each experimental condition for respiratory
effort and flow, and for EEG, EMG, and ECG.
Respiratory instability will first be assessed while subjects are under sedation without any
airway provocation. The degree of respiratory instability will be quantified in terms of the
following measurements: a modified Respiratory Disturbance Index (RDIsedated), respiratory
arousals, and minute ventilation. The apneic periods will be classified by their mixture of
central and obstructive components.All outcome measurements are assessed over the period of
sedation which last for approximately one hour.
Upper airway patency will be quantified in terms of the critical pharyngeal pressure (Pcrit)
(the pressure beyond which complete upper airway collapse occurs, see background).