Improved Patient Recovery After Anesthesia
The proposed study will measure the incidence of adverse events and the decrease in time to meet discharge criteria from the post anesthesia care unit when hypercapnic and hyperpnoea are used during emergence.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Improved Patient Recovery of Spontaneous Respiration After Anesthesia With Hypercapnic Hyperpnoea|
- treatment (inspired CO2) caused patients to breath more vigorously [ Time Frame: 30 min ] [ Designated as safety issue: No ]Chest bands measuring the patients tidal volume will show that patients who receive the treatment will have larger tidal volumes than patients in the control group during the first 10 minutes after the end of surgery
- treatment caused the anesthetic vapors to be cleared more rapidly [ Time Frame: 30 min ] [ Designated as safety issue: No ]A anesthetic gas analyzer will measure the amount of anesthetic gas in the patient's exhaled gas and will show that patients who receive the treatment will have lower exhaled anesthetic gas concentration than patients in the control group during the first 10 minutes after the end of surgery
|Study Start Date:||April 2010|
|Study Completion Date:||April 2011|
|Primary Completion Date:||April 2011 (Final data collection date for primary outcome measure)|
Active Comparator: inspired CO2
Use of the QED-100 results in mild hypercapnia during emergence
No Intervention: No intervention: Standard of Care
tidal volume and respiratory rate are not changed during recovery from anesthesia
Hypercapnia has been used in conjunction with hyperpnoea to provide a more rapid return of responsiveness after inhaled anesthesia. The benefits of accelerating patient recovery in the operating room may extend to the post anesthesia care unit if the patient is more alert and easier to care for when they arrive in the unit. Respiratory patterns and gas levels - including CO2, O2, and anesthetic vapor - will be measured in order to better understand a patient's respiratory status during recovery.
In Feb 2009 we finished our first study (IRB 26111) and submitted a publication. The journal reviewers identified a serious limitation: we could not report whether the treated patients recovered from anesthesia faster because the treatment (inspired CO2) caused them to breath more vigorously or because the treatment caused the anesthetic vapors to be cleared more rapidly from the brain. Our new application uses essentially the same study protocol as the former study but adds chest bands to measure the patient's rate of breathing and expired gas monitoring to measure the rate at which the vapors are removed.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01477398
|United States, Utah|
|Salt Lake City, Utah, United States, 84132|