Classic and Modified Rapid Sequence Induction for Prevention of Gastric Content Regurgitation

March 16, 2020 updated by: The First Affiliated Hospital with Nanjing Medical University

Comparison of Classic and Modified Rapid Sequence Induction on Prevention of Perioperative Gastric Content Regurgitation in Emergency Surgery Under General Anesthesia

Induction of anesthesia induces a loss of protective upper airway reflexes and is associated with gastric content regurgitation. Emergency surgery bears a higher risk of gastric content regurgitation because of full stomach, delayed gastric emptying, intestinal obstruction, stroke or other factors. Rapid sequence induction (RSI) of anesthesia was recommended to minimize the risk of regurgitation and aspiration. Classic RSI scheme mainly includes the use of short-acting sedatives and muscle relaxant, together with a manual pressure to the cricoid cartilage (Sellick maneuver) which aims at compressing the esophagus to avoid regurgitation. Though widely recommended, the scheme has been controversial for years. Our department modified the scheme and put it into use in day shift emergency surgery since March 1, 2018. This retrospective analysis is aimed at comparing the effect of classic and modified rapid sequence induction in prevention of gastric content regurgitation in emergency surgery under general anesthesia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

8601

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

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210029
        • The First Affiliated Hospital of Nanjing Medical University

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

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients receive emergency surgery under general anesthesia.

Description

Inclusion Criteria:

  • Patients receive emergency surgery under general anesthesia March 1, 2015 to February 29, 2020
  • Eighteen years or older

Exclusion Criteria:

  • Trachea intubation status on admission
  • Tracheotomy
  • Bronchoscope surgery
  • General anesthesia with laryngeal mask
  • Awake intubation

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

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group C
General anesthesia was induced with classic rapid sequence induction protocol.
Procedure: Classic rapid sequence induction
In classic RSI scheme, patients are in supine position during induction and intubation. Sellick's technic is applied after sedatives and muscle relaxant are given.
Group M
General anesthesia was induced with modified rapid sequence induction protocol.
Procedure: Modified rapid sequence induction
Modified RSI was put into use in day shift emergency surgery since March 1, 2018. In this scheme, dorsal elevated position and apneic oxygenation technic are applied. Positive pressure mask ventilation is avoided unless necessary. Sellick's technic is not used in this scheme.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of gastric content regurgitation
Time Frame: From entering operation room to endotracheal intubation completed.
The Electronic Anesthesia Record System files contained the word "aspiration" and/or "gastric content" were extracted and carefully evaluated. The events of gastric content regurgitation on admission or observed during tracheal intubation were recorded and analyzed.
From entering operation room to endotracheal intubation completed.

Collaborators and Investigators

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

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Investigators

  • Principal Investigator: Zhengnian Ding, M.D., The First Affiliated Hospital with Nanjing Medical University

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 (Actual)

March 5, 2020

Primary Completion (Actual)

March 8, 2020

Study Completion (Actual)

March 15, 2020

Study Registration Dates

First Submitted

March 16, 2020

First Submitted That Met QC Criteria

March 16, 2020

First Posted (Actual)

March 18, 2020

Study Record Updates

Last Update Posted (Actual)

March 18, 2020

Last Update Submitted That Met QC Criteria

March 16, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • 2020-SR-093

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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.

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