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CompletedNCT04312425Updated Mar 18, 2020

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

An observational study in Rapid Sequence Induction, sponsored by The First Affiliated Hospital with Nanjing Medical University. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-03-18.

Sponsored by The First Affiliated Hospital with Nanjing Medical University · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
8,601
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Rapid Sequence Induction
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In context

Lead sponsor

The First Affiliated Hospital with Nanjing Medical University is the lead sponsor of 543 studies on the registry; 301 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients receive emergency surgery under general anesthesia.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Retrospective
Enrollment
8,601 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • ProcedureModified 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.

  • ProcedureClassic 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.

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What researchers measure

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.

    Time frame: From entering operation room to endotracheal intubation completed.

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Study locations

1 site
  • The First Affiliated Hospital of Nanjing Medical University
    Nanjing, Jiangsu 210029, China
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 18, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04312425
Lead sponsor
The First Affiliated Hospital with Nanjing Medical University
Responsible party
Sponsor
First posted
Mar 18, 2020
Start date
Mar 5, 2020
Primary completion
Mar 8, 2020
Completion
Mar 15, 2020
Last update
Mar 18, 2020

Study contacts

Zhengnian Ding, M.D.
principal investigator · The First Affiliated Hospital with Nanjing Medical University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.

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