Study Stopped
no funding available
Modified Rapid Sequence Induction in Morbidly Obese Patients
1 other identifier
interventional
N/A
1 country
1
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.
Trial Health
Trial Health Score
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Started Feb 2021
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 16, 2017
CompletedFirst Posted
Study publicly available on registry
August 4, 2017
CompletedStudy Start
First participant enrolled
February 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2021
CompletedFebruary 18, 2021
February 1, 2021
Same day
June 16, 2017
February 16, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Amount of air aspirated with a gastric tube
The amount of air that can be aspirated via a nasogastric tube at the beginning of laparoscopy. 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.
at the beginning of the laparoscopy
Secondary Outcomes (2)
Gastric inflation
at the beginning of laparoscopy
partial pressure of oxygen in arterial blood (paO2)
before pre oxygenation, before anesthesia induction, before laryngoscopy, immediately after intubation when the cuff of the tracheal tube is inflated
Study Arms (4)
t-RSI
EXPERIMENTALRapid 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.
m-RSI-PEEP
EXPERIMENTALRapid 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.
m-RSI-vent
EXPERIMENTALRapid 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.
m-RSI-vent-cric
EXPERIMENTALRapid 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.
Interventions
Preoxygenation via face mask, no ventilation with no PEEP until intubation
Preoxygenation via facemask with PEEP of 10 mbar. PEEP will be continued until intubation.
Preoxygenation via facemask with 10 mbar PEEP and 8 mbar pressure support. Backup frequency set at 10/min. Ventilation via anesthetic machine until intubation.
Preoxygenation via facemask with 10 mbar PEEP and 8 mbar pressure support. Backup frequency set at 10/min. Ventilation via anesthetic machine until intubation.
Cricoid Pressure will be applied during RSI until laryngoscopy
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).
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.
The impression of gastric inflation at laparoscopy. At the beginning of laparoscopy, images of the stomach will be recorded.
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.
Eligibility Criteria
You may qualify if:
- BMI \> 40
- American Society of Anesthesiology Class 1-3
- Elective laparoscopic surgery
You may not qualify if:
- Pregnant or breastfeeding patients
- Previous bariatric surgery
- Anticipated difficult airway
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medical University of Vienna
Vienna, 1090, Austria
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Walter Plöchl, Professor
Medical University of Vienna
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Univ. Prof. Dr.
Study Record Dates
First Submitted
June 16, 2017
First Posted
August 4, 2017
Study Start
February 1, 2021
Primary Completion
February 1, 2021
Study Completion
February 1, 2021
Last Updated
February 18, 2021
Record last verified: 2021-02