NCT03239236

Modified Rapid Sequence Induction in Morbidly Obese Patients

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Medical University of Vienna · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Anesthesia Intubation Complication

Interventions

Type	Name	Description
PROCEDURE	Rapid sequence induction t-RSI	Preoxygenation via face mask, no ventilation with no PEEP until intubation
PROCEDURE	Rapid sequence induction m-RSI-PEEP	Preoxygenation via facemask with PEEP of 10 mbar. PEEP will be continued until intubation.
PROCEDURE	Rapid sequence induction m-RSI-vent	Preoxygenation via facemask with 10 mbar PEEP and 8 mbar pressure support. Backup frequency set at 10/min. Ventilation via anesthetic machine until intubation.
PROCEDURE	m-RSI-vent-cric	Preoxygenation via facemask with 10 mbar PEEP and 8 mbar pressure support. Backup frequency set at 10/min. Ventilation via anesthetic machine until intubation.
PROCEDURE	Cricoid Pressure	Cricoid Pressure will be applied during RSI until laryngoscopy
DRUG	Anesthetics	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).
DIAGNOSTIC_TEST	Aspiration of gastric air via nasogastric tube	A nasogastric tube will be inserted at the beginning of laparoscopy and the air from the stomach will be aspirated with a syringe. The amount of air will be measured in ml.
DIAGNOSTIC_TEST	Impression of gastric inflation at laparoscopy.	The impression of gastric inflation at laparoscopy. At the beginning of laparoscopy, images of the stomach will be recorded.
DIAGNOSTIC_TEST	Arterial blood gas	Arterial blood gases will we drawn at different time points to investigate oxygenation during the procedure. Blood gases will be taken before pre-oxygenation, before anesthesia induction, before laryngoscopy, immediately after intubation when the cuff of the tracheal tube is inflated.

Timeline

• Start date: 2021-02-01
• Primary completion: 2021-02-01
• Completion: 2021-02-01
• First posted: 2017-08-04
• Last updated: 2021-02-18

Locations

1 site across 1 country: Austria