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Modified Rapid Sequence Induction in Morbidly Obese Patients

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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Withdrawn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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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