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

Sponsor

The First Affiliated Hospital with Nanjing Medical University (Other)

Overall Status

Completed

CT.gov ID

NCT04312425

Collaborator

(none)

8,601

Enrollment

Location

Actual Duration (Days)

26179.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Rapid Sequence Induction	Procedure: Modified rapid sequence induction Procedure: Classic rapid sequence induction

Study Design

Study Type:

Observational

Actual Enrollment :

8601 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Mar 5, 2020

Actual Primary Completion Date :

Mar 8, 2020

Actual Study Completion Date :

Mar 15, 2020

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

Incidence of gastric content regurgitation [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The First Affiliated Hospital of Nanjing Medical University	Nanjing	Jiangsu	China	210029

Sponsors and Collaborators

The First Affiliated Hospital with Nanjing Medical University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

The First Affiliated Hospital with Nanjing Medical University

ClinicalTrials.gov Identifier:

NCT04312425

Other Study ID Numbers:

2020-SR-093

First Posted:

Mar 18, 2020

Last Update Posted:

Mar 18, 2020

Last Verified:

Mar 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Mar 18, 2020