Clinical trial NCT03239236: Modified Rapid Sequence Induction in Morbidly Obese Patients
Official title: Modified Rapid Sequence Induction in Morbidly Obese Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Anesthesia Intubation Complication
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2017-08-04
Enrollment: 0
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* BMI \> 40
* American Society of Anesthesiology Class 1-3
* Elective laparoscopic surgery

Exclusion Criteria:

* Pregnant or breastfeeding patients
* Previous bariatric surgery
* Anticipated difficult airway

Primary outcomes:
measure: Amount of air aspirated with a gastric tube
timeFrame: at the beginning of the laparoscopy
Secondary outcomes:
measure: Gastric inflation
timeFrame: at the beginning of laparoscopy
measure: partial pressure of oxygen in arterial blood (paO2)
timeFrame: before pre oxygenation, before anesthesia induction, before laryngoscopy, immediately after intubation when the cuff of the tracheal tube is inflated
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
affiliation: Medical University of Vienna
name: Walter Plöchl, Professor
role: PRINCIPAL_INVESTIGATOR
References: