Oxygen Saturation Monitoring During Surgery
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|ClinicalTrials.gov Identifier: NCT01098851|
Recruitment Status : Completed
First Posted : April 5, 2010
Results First Posted : June 29, 2011
Last Update Posted : August 7, 2014
|Condition or disease|
|Sleep Apnea, Obstructive|
Patients with Obstructive Sleep Apnea (OSA) have episodes of upper airway obstruction during sleep which have been shown to be accompanied by multiple oxygen desaturations followed by short recovery intervals until rising PaCO2 causes sleep disruption/rescue arousal. In the postoperative and conscious sedation arena, these patterns can deteriorate from a stable pattern to a severely unstable pattern which may go unrecognized and lead to an adverse event (respiratory/cardiac arrest; death).
Anesthesia and the higher consumption of analgesics produce a profound reduction in pharyngeal tone, a dampening of both chemoreceptor sensitivity and arousal/rescue response. Thus the first 48 hours post operatively presents a vulnerable period. Respiratory disturbances are more prominent - respiratory arrest and hypopnea being the main adverse occurrences during this period.
An algorithm has been developed that monitors saturation and indicates repetitive reductions in airflow through the upper airway and into the lungs. Presence of this pattern in the procedural sedation patient population has not been tested for its prevalence. This study will monitor patients during surgery to determine if this pattern occurs in this hospital setting.
|Study Type :||Observational|
|Actual Enrollment :||21 participants|
|Observational Model:||Case Control|
|Official Title:||Saturation Pattern Detection Prevalence Study Protocol|
|Study Start Date :||July 2009|
|Actual Primary Completion Date :||November 2009|
|Actual Study Completion Date :||November 2009|
Obstructive Sleep Apnea
Surgery patients at high risk for Obstructive Sleep Apnea
Surgery patients at low risk for Obstructive Sleep Apnea
- Number of Participants With Saturation Pattern Detection (SPD) Indicative of Repetitive Reductions in Air Flow [ Time Frame: 3 hours ]Saturation Pattern Detection (SPD) is the pattern of oxygen saturation values plotted against time that occurs when patients have cyclical reduced air movement during breathing. Their blood oxygen level decreases and increases as they slow and increase their breathing.
- Number of Participants Requiring Airway Support [ Time Frame: 3 hours ]Drugs during surgery may cause the throat to relax and block breathing. To treat this, the caregiver administers airway support. Airway support is moving the jaw forward, inserting a plastic tube (nasal-oral airway) or applying a mask with positive pressure.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01098851
|United States, Colorado|
|Avista Adventist Hospital|
|Louisville, Colorado, United States, 80027|
|Study Chair:||Roger Mecca, MD||Medtronic - MITG|