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This study investigates the effect of 4 different methods of rapid sequence induction (RSI) in morbidly obese patients on the amount of air insufflation into the stomach.
100 adult patients with a body mass index \> 40 undergoing elective laparoscopic surgery will be included. Patients with a history of previous bariatric surgery or with an anticipated difficult airway will be excluded. The randomization will be 1:1:1:1 stratified for gastro-esophageal reflux disease. All groups will receive standardized preoperative continuous positive airway pressure (CPAP) therapy. In the operation theater, Group one will receive pre-oxygenation for 3 minutes via a tight fitting face mask without positive end-expiratory pressure (PEEP). Induction agents will be administered as quick boluses (Propofol 2,5mg/kg total body weight, max 350mg, Fentanyl 250mcg, Rocuronium 1,2mg/kg ideal body weight) and tracheal intubation will be performed after 1 minute. No bag mask ventilation will be performed in-between. Group 2 will receive pre-oxygenation via a tight face mask with a PEEP of 10 mbar for 3 minutes. The same induction agents as in group one will be administered. PEEP via facemask will be continued for one minute and tracheal intubation will be performed. Group 3 will receive pre-oxygenation via a tight fitting facemask with a PEEP of 10 mbar with additional pressure support of 8 mbar and a back up ventilation frequency will be set to 10/min. After the same induction agents are given as in group 1, patients will receive non-invasive ventilation via ventilator at the settings described earlier for group 3. Group 4 will receive the same induction as group 3, in addition a cricoid pressure will be applied during the non invasive ventilation.
Age
19 - No limit years
Sex
ALL
Healthy Volunteers
No
Medical University of Vienna
Vienna, Austria
Start Date
February 1, 2021
Primary Completion Date
February 1, 2021
Completion Date
February 1, 2021
Last Updated
February 18, 2021
Rapid sequence induction t-RSI
PROCEDURE
Rapid sequence induction m-RSI-PEEP
PROCEDURE
Rapid sequence induction m-RSI-vent
PROCEDURE
m-RSI-vent-cric
PROCEDURE
Cricoid Pressure
PROCEDURE
Anesthetics
DRUG
Aspiration of gastric air via nasogastric tube
DIAGNOSTIC_TEST
Impression of gastric inflation at laparoscopy.
DIAGNOSTIC_TEST
Arterial blood gas
DIAGNOSTIC_TEST
Lead Sponsor
Medical University of Vienna
NCT06091631
NCT05941767
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT03902704