Modified Rapid Sequence Induction in Morbidly Obese Patients

February 16, 2021 updated by: Thomas Hamp, Medical University of Vienna
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • Medical University of Vienna

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

15 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: t-RSI

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.
Procedure: Rapid sequence induction t-RSI
Preoxygenation via face mask, no ventilation with no PEEP until intubation
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).
Other Names:
  • Induction Agents
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.
Experimental: m-RSI-PEEP

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.
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).
Other Names:
  • Induction Agents
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.
Procedure: Rapid sequence induction m-RSI-PEEP
Preoxygenation via facemask with PEEP of 10 mbar. PEEP will be continued until intubation.
Experimental: m-RSI-vent

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.
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).
Other Names:
  • Induction Agents
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.
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.
Experimental: m-RSI-vent-cric

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.
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).
Other Names:
  • Induction Agents
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.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Amount of air aspirated with a gastric tube
Time Frame: at the beginning of the laparoscopy
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Gastric inflation
Time Frame: at the beginning of laparoscopy
The impression of gastric inflation at laparoscopy. At the beginning of laparoscopy, images of the stomach will be recorded. These images will afterwards be reviewed in a blinded fashion by three different investigators. The investigators will rate their impression of gastric inflation (empty, mildly inflated, inflated, very inflated).
at the beginning of laparoscopy
partial pressure of oxygen in arterial blood (paO2)
Time Frame: before pre oxygenation, before anesthesia induction, before laryngoscopy, immediately after intubation when the cuff of the tracheal tube is inflated
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, after intubation.
before pre oxygenation, before anesthesia induction, before laryngoscopy, immediately after intubation when the cuff of the tracheal tube is inflated

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medical University of Vienna

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Walter Plöchl, Professor, Medical University of Vienna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 16, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 31, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 4, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 18, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 16, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Modified RSI in morbidly obese

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Anesthesia Intubation Complication

Clinical Trials on Rapid sequence induction t-RSI

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings