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

NCT ID: NCT04312425

Last Updated: 2020-03-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

8601 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-05

Study Completion Date

2020-03-15

Brief Summary

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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.

Detailed Description

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Conditions

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Rapid Sequence Induction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Group C

General anesthesia was induced with classic rapid sequence induction protocol.

Classic rapid sequence induction

Intervention Type PROCEDURE

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.

Modified rapid sequence induction

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Zhengnian Ding, M.D.

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital with Nanjing Medical University

Locations

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The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Site Status

Countries

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China

Other Identifiers

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2020-SR-093

Identifier Type: -

Identifier Source: org_study_id

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