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

NCT04312425 | Completed

• 1 other identifier: 2020-SR-093
• Study Type: observational
• Target: 8,601
• Locations: 1 country
• Sites: 1

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.

Conditions

Rapid Sequence Induction

Outcome Measures

Primary Outcomes (1)

• Incidence of gastric content regurgitation

  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.

Study Arms (2)

Group C

General anesthesia was induced with classic rapid sequence induction protocol.

Procedure: Classic rapid sequence induction

Group M

General anesthesia was induced with modified rapid sequence induction protocol.

Procedure: Modified rapid sequence induction

Interventions

Modified rapid sequence induction 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.

Group M

Classic rapid sequence induction 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 C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients receive emergency surgery under general anesthesia.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210029, China

Location

Study Officials

• Zhengnian Ding, M.D.

  The First Affiliated Hospital with Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2020
• First Posted: March 18, 2020
• Study Start: March 5, 2020
• Primary Completion: March 8, 2020
• Study Completion: March 15, 2020
• Last Updated: March 18, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)