Rapid Sequence InductionNCT04312425
Classic and Modified Rapid Sequence Induction for Prevention of Gastric Content Regurgitation
An observational study of Rapid Sequence Induction, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rapid Sequence Induction
- What is being tested?
- Modified rapid sequence induction and Classic rapid sequence induction
- Type of treatment
- Surgery or procedure
- How many people
- 8,601 participants
- Where
- 1 siteChina
- Study dates
- 5 Mar 2020to 15 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients receive emergency surgery under general anesthesia.
Who may be able to join
- Patients receive emergency surgery under general anesthesia March 1, 2015 to February 29, 2020
- Eighteen years or older
Who cannot join
- Trachea intubation status on admission
- Tracheotomy
- Bronchoscope surgery
- General anesthesia with laryngeal mask
- Awake intubation
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210029
About this study
Official title: 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.
- Conditions
- Rapid Sequence Induction
- Being tested
- Modified rapid sequence induction, Classic rapid sequence induction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified rapid sequence inductionProcedure or surgery
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.
Classic rapid sequence inductionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Group C | General anesthesia was induced with classic rapid sequence induction protocol. Receives: Procedure: Classic rapid sequence induction | |
| Group M | General anesthesia was induced with modified rapid sequence induction protocol. Receives: Procedure: Modified rapid sequence induction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From entering operation room to endotracheal intubation completed.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2020
- Study start5 Mar 2020
- Primary completion8 Mar 2020
- Study completion15 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rapid Sequence InductionStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 8,601 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhengnian Ding, M.D., Principal investigator, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04312425
- Sponsor's protocol ID
- 2020-SR-093
- Status last verified
- Mar 2020
- First submitted
- 16 Mar 2020
- Last updated
- 18 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Classic and Modified Rapid Sequence Induction on Prevention of Perioperative Gastric Content Regurgitation in Emergency Surgery Under General Anesthesia
- ClinicalTrials.gov ID
- NCT04312425
- Acronym / sponsor ID
- 2020-SR-093
- Conditions
- Rapid Sequence Induction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8,601 participants (actual)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 5 Mar 2020 (actual)
- Primary completion
- 8 Mar 2020 (actual)
- Study completion
- 15 Mar 2020 (actual)
- First posted
- 18 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group C | – | Procedure: Classic rapid sequence inductionGeneral anesthesia was induced with classic rapid sequence induction protocol. |
| Group M | – | Procedure: Modified rapid sequence inductionGeneral anesthesia was induced with modified rapid sequence induction protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients receive emergency surgery under general anesthesia.
Key inclusion criteria (2 listed)
- Patients receive emergency surgery under general anesthesia March 1, 2015 to February 29, 2020
- Eighteen years or older
Key exclusion criteria (5 listed)
- Trachea intubation status on admission
- Tracheotomy
- Bronchoscope surgery
- General anesthesia with laryngeal mask
- Awake intubation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Modified rapid sequence inductionModified 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. | Procedure or surgery | Group M |
| Classic rapid sequence inductionIn classic RSI scheme, patients are in supine position during induction and intubation. Sellick's technic is applied after sedatives and muscle relaxant are given. | Procedure or surgery | Group C |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2020.
- Individual participant dataSharing planned: No
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Pain Assessment During Rapid Sequence Induction
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Which Rapid Sequence Induction Technique Should be Used in Urgent Surgery in Children?
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Comparison of Peri-intubation Oxygenation Values and Complications in Patients Intubated With the Delayed Versus Rapid Sequence Intubation Protocols
Delayed Sequence Intubation, Rapid Sequence Induction and Intubation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhengnian Ding, M.D. principal investigator
The First Affiliated Hospital with Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rapid Sequence Induction, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of gastric content regurgitation (time frame: From entering operation room to endotracheal intubation completed.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2020.