Modified Rapid Sequence Induction in Morbidly Obese Patients

Medical University of Vienna

Status: Withdrawn

Conditions: Anesthesia Intubation Complication

Treatments: Diagnostic Test: Arterial blood gas; Procedure: Rapid sequence induction m-RSI-PEEP; Drug: Anesthetics; Procedure: Cricoid Pressure; Diagnostic Test: Aspiration of gastric air via nasogastric tube; Procedure: m-RSI-vent-cric; Procedure: Rapid sequence induction m-RSI-vent; Diagnostic Test: Impression of gastric inflation at laparoscopy.; Procedure: Rapid sequence induction t-RSI

Study type: Interventional

Funder types: Other

Identifiers

NCT03239236

Modified RSI in morbidly obese

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 4 patient groups

t-RSI

Experimental group

Description:

Rapid sequence induction t-RSI. Traditional rapid sequence induction with Anesthetics. Preoxygenation via face mask, no ventilation with no PEEP until intubation. Aspiration of gastric air via nasogastric tube at the beginning of laparoscopy. Impression of gastric inflation at laparoscopy will be assessed by taking images of the stomach at the beginning of laparoscopy. Arterial blood gas samples will be taken at different time points.

Treatment:

Diagnostic Test: Impression of gastric inflation at laparoscopy.

Diagnostic Test: Arterial blood gas

Diagnostic Test: Aspiration of gastric air via nasogastric tube

Drug: Anesthetics

Procedure: Rapid sequence induction t-RSI

m-RSI-PEEP

Experimental group

Description:

Rapid sequence induction m-RSI-PEEP. Modified rapid sequence induction with Anesthetics and PEEP. Preoxygenation via facemask with PEEP of 10 mbar. PEEP will be continued until intubation. Aspiration of gastric air via nasogastric tube at the beginning of laparoscopy. Impression of gastric inflation at laparoscopy will be assessed by taking images of the stomach at the beginning of laparoscopy. Arterial blood gas samples will be taken at different time points.

Treatment:

Diagnostic Test: Impression of gastric inflation at laparoscopy.

Diagnostic Test: Arterial blood gas

Diagnostic Test: Aspiration of gastric air via nasogastric tube

Procedure: Rapid sequence induction m-RSI-PEEP

Drug: Anesthetics

m-RSI-vent

Experimental group

Description:

Rapid sequence induction m-RSI-vent. Modified rapid sequence induction with Anesthetics and intermittent ventilation. Preoxygenation via facemask with 10 mbar PEEP and 8 mbar pressure support. Backup frequency set at 10/min. Ventilation via anesthetic machine until intubation. Aspiration of gastric air via nasogastric tube at the beginning of laparoscopy. Impression of gastric inflation at laparoscopy will be assessed by taking images of the stomach at the beginning of laparoscopy. Arterial blood gas samples will be taken at different time points.

Treatment:

Diagnostic Test: Impression of gastric inflation at laparoscopy.

Diagnostic Test: Arterial blood gas

Diagnostic Test: Aspiration of gastric air via nasogastric tube

Drug: Anesthetics

Procedure: Rapid sequence induction m-RSI-vent

m-RSI-vent-cric

Experimental group

Description:

Rapid sequence induction m-RSI-vent-cric. Modified rapid sequence induction with Anesthetics and intermittent ventilation and cricoid pressure. Same as "modified rapid sequence induction with intermittent ventilation" arm with additional cricoid pressure. Aspiration of gastric air via nasogastric tube at the beginning of laparoscopy. Impression of gastric inflation at laparoscopy will be assessed by taking images of the stomach at the beginning of laparoscopy. Arterial blood gas samples will be taken at different time points.

Treatment:

Diagnostic Test: Impression of gastric inflation at laparoscopy.

Diagnostic Test: Arterial blood gas

Diagnostic Test: Aspiration of gastric air via nasogastric tube

Procedure: Cricoid Pressure

Procedure: m-RSI-vent-cric

Drug: Anesthetics