Rapid Sequence Induction of General AnesthesiaPhase 3IRISNCT02080754
Sellick Interest in Rapid Sequence Induction
A Phase 3 study testing effective sellick maneuver in people with Rapid Sequence Induction of General Anesthesia and Sellick Maneuver, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Lung aspiration can occur when a rapid sequence induction of anesthesia is performed (emergency and/or presence of at least one risk factor for regurgitation of stomach contents). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rapid Sequence Induction of General Anesthesia, Sellick Maneuver, Acid Aspiration Syndrome
- What is being tested?
- effective sellick maneuver
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3,472 participants
- Where
- 1 siteFrance
- Study dates
- 4 Feb 2014to Jul 2017
- Phase
- Phase 3
- 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
Who may be able to join
- Patients older than 18 yr undergoing general anaesthesia requiring rapid sequence induction (full stomach or presence of at least one risk factor for regurgitation of stomach content) are eligible.
- Obtain informed consent from the patient or a close relative/surrogate. Should such a person be absent, the patient will be randomized according to the specifications of emergency consent and the patient will be asked to give his/her consent for the continuation of the trial when his/her condition will allow.
Who cannot join
- Non consent patients,
- Pregnancy,
- Contraindication to Sellick maneuver
- Contraindication to succinylcholine
- Patients with predictive signs of bronchopneumonia during the preanesthetic consultation ,
- Patients with pulmonary contusion
Show all 12Show fewer
- Upper respiratory tract abnormalities
- Laryngeal trauma
- Patients requiring an alternative to direct laryngoscopy
- Patients with troubles of consciousness
- Use of plastic single used laryngoscopic blade
- Use of rocuronium as neuromuscular blockade agent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sellick Maneuver Evaluation in Rapid Sequence Induction of General Anesthesia Non Inferiority Trial
Lung aspiration can occur when a rapid sequence induction of anesthesia is performed (emergency and/or presence of at least one risk factor for regurgitation of stomach contents).
The aim of this study is to assess the Sellick maneuver, which is recommended for patient at high risk of aspiration of gastric content during induction of general anesthesia, despite the lack of solid evidence of its efficacy and possible adverse effects The primary outcome of this non inferiority study is the incidence of lung aspiration whether this maneuver is effectively applied or sham.
Read the detailed description
Introduction:
Lung aspiration is an inherent complication of the loss of protective upper airway reflexes during general anesthesia. Its incidence is low in elective surgery, when preoperative fasting rules have been complied and in absence of risk factors for regurgitation of gastric contents. In emergency conditions, non-compliance with preoperative fasting rules and delayed gastric emptying increase the risk of regurgitation and therefore lung aspiration of gastric contents. In this context, a rapid sequence induction of anaesthesia is recommended to minimize the risk of regurgitation which combines the use of short delay and short duration of action anesthetics agents associated with the application of a Sellick maneuver. The goal of this maneuver is to collapse the esophagus by compressing it between the cricoid cartilage and the fifth cervical vertebra. Because of the low level of evidence supporting the Sellick maneuver in the literature, this maneuver, remains controversial although recommended.
Hypothesis: The aim of this study is to assess the Sellick maneuver during rapid sequence induction in adults (pregnant women excluded) by comparing the incidence of lung aspiration whether this maneuver is applied or sham, in a noninferiority trial.
Primary endpoint: Incidence of lung aspiration
Secondary endpoints: Cormack and Lehane Grade , frequency of difficult intubation, frequency of impossible intubation, effect of releasing the Sellick maneuver on these three criteria, frequency of aspiration pneumonia within 24 hours, frequency of complications due to the Sellick maneuver (esophageal rupture and cricoid cartilage fracture rates) and mortality at day 28 or at hospital discharge.
Methods: This is a multicenter, randomized, double-blind, non-inferiority trial. We compare a group of patients benefiting from a rapid sequence induction without achieving the Sellick maneuver, where the movement is fake (sham group) with a group of patients undergoing a rapid sequence induction with effective execution of this maneuver (Sellick group). The two patient groups differ only by the effective or sham application of the Sellick maneuver .
In both arms, the Sellick maneuver , whether real or fake , can be released at the request of the person performing orotracheal intubation in particular to improve intubating conditions or in case of active vomiting. However, it should be kept in case of need for ventilation facemask.
Number of patients: The number of patients is estimated at 1 750 patients per group and so 3500 patients.
Inclusion criteria: patients older than 18 yr undergoing general anesthesia requiring rapid sequence induction (full stomach or presence of at least one risk factor for regurgitation of stomach content) are eligible.
Exclusion criteria: patients non consenting, pregnancy, contraindication to Sellick maneuver or succinylcholine, patients with predictive signs of bronchopneumonia during the preanesthetic consultation, patients with pulmonary contusion, upper respiratory tract abnormalities, laryngeal trauma, patients requiring an alternative to direct laryngoscopy, patients with troubles of consciousness, use of plastic single used laryngoscopic blade, use of rocuronium as neuromuscular blockade agent.
- Conditions
- Rapid Sequence Induction of General Anesthesia, Sellick Maneuver, Acid Aspiration Syndrome, Lung Aspiration, Aspiration Pneumonia
- Being tested
- effective sellick maneuver, sham sellick maneuver
- Keywords
- Crush induction, Cricoid pressure, Sellick maneuver, Lung aspiration, Aspiration pneumonia
- Medical subject headings
- Pneumonia, Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
effective sellick maneuverOther
Sellick maneuver is applied, as originally described by Sellick et al .
sham sellick maneuverOther
The operator who applied the maneuver is the only person who knows the arm inclusion of the patient. Thus, he sets his fingers as described in Sellick arms without exerting pressure on the cricoid cartilage.
| Study group | Role | What they receive |
|---|---|---|
| sham arm | Placebo comparator | sham sellick maneuver Receives: Other: sham sellick maneuver |
| sellick arm | Experimental | effective sellick maneuver Receives: Other: effective sellick maneuver |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of lung aspiration
in the operating room presence of gastric fluid on the vocal cords at the orotracheal intubation or in endotracheal suction when performed immediately after intubation
Measured: Within 1 hour
Secondary outcomes (10)
Cormack and Lehane Grade
During orotracheal intubation
Measured: Within 1 hour
Frequency of use of a mask ventilation
In the operating room, if needed, the mask ventilation will be recorded
Measured: Within 1 hour
Number of times the Sellick maneuver should be discontinued
In the operating room, if the person who realize the intubation requires a loosening of the Sellick manoeuver, whether real or feigned (difficult intubation, vomiting)
Measured: Within 1 hour
Effects of releasing the Sellick maneuver on the conditions of tracheal intubation assessed by Cormack and Lehane grade
During orotracheal intubation
Measured: Within 1 hour
Incidence of difficult and impossible intubation
difficult intubation is defined by more than two attempts or the need for an alternative technique. Impossible intubation is defined by the need to awake the patient or perform a tracheotomy or cricothyrotomy rescue.
Measured: Within 1 hour
Incidence of aspiration pneumonia
Aspiration pneumonia is defined by the association of a lung aspiration recorded in the operating room during the induction of anesthesia and the presence of a non-existent preoperative radiological infiltrate
Measured: within the 24 hours
Incidence of oesophageal rupture
This complication is extremely rare and clinically very telling. No further review is planned to diagnose it
Measured: day 28
Incidence of cricoid cartilage fracture
This complication is extremely rare and clinically very telling. No further review is planned to diagnose it.
Measured: day 28
Mortality
Measured: day 28
Mortality
Measured: Hospital discharge Hospital discharge if anterior at day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2014 (estimated)
- Study start4 Feb 2014
- Primary completionFeb 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rapid Sequence Induction of General AnesthesiaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 3,472 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aurelie Birenbaum, MD, Principal investigator, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02080754
- Sponsor's protocol ID
- P 120120
- Other IDs
- 2013-A00624-41
- Acronym
- IRIS
- Status last verified
- Nov 2017
- First submitted
- 17 Feb 2014
- Last updated
- 21 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Birenbaum A, Hajage D, Roche S, Ntouba A, Eurin M, Cuvillon P, Rohn A, Compere V, Benhamou D, Biais M, Menut R, Benachi S, Lenfant F, Riou B; IRIS Investigators Group. Effect of Cricoid Pressure Compared With a Sham Procedure in the Rapid Sequence Induction of Anesthesia: The IRIS Randomized Clinical Trial. JAMA Surg. 2019 Jan 1;154(1):9-17. doi: 10.1001/jamasurg.2018.3577.
PubMed 30347104
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sellick Maneuver Evaluation in Rapid Sequence Induction of General Anesthesia Non Inferiority Trial
- ClinicalTrials.gov ID
- NCT02080754
- Acronym / sponsor ID
- IRIS / P 120120
- Conditions
- Rapid Sequence Induction of General Anesthesia, Sellick Maneuver, Acid Aspiration Syndrome, Lung Aspiration, Aspiration Pneumonia
- Keywords
- Crush induction, Cricoid pressure, Sellick maneuver, Lung aspiration, Aspiration pneumonia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,472 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 4 Feb 2014 (actual)
- Primary completion
- Feb 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 6 Mar 2014 (estimated)
- 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.
Lung aspiration can occur when a rapid sequence induction of anesthesia is performed (emergency and/or presence of at least one risk factor for regurgitation of stomach contents).
The aim of this study is to assess the Sellick maneuver, which is recommended for patient at high risk of aspiration of gastric content during induction of general anesthesia, despite the lack of solid evidence of its efficacy and possible adverse effects The primary outcome of this non inferiority study is the incidence of lung aspiration whether this maneuver is effectively applied or sham.
Detailed description
Introduction:
Lung aspiration is an inherent complication of the loss of protective upper airway reflexes during general anesthesia. Its incidence is low in elective surgery, when preoperative fasting rules have been complied and in absence of risk factors for regurgitation of gastric contents. In emergency conditions, non-compliance with preoperative fasting rules and delayed gastric emptying increase the risk of regurgitation and therefore lung aspiration of gastric contents. In this context, a rapid sequence induction of anaesthesia is recommended to minimize the risk of regurgitation which combines the use of short delay and short duration of action anesthetics agents associated with the application of a Sellick maneuver. The goal of this maneuver is to collapse the esophagus by compressing it between the cricoid cartilage and the fifth cervical vertebra. Because of the low level of evidence supporting the Sellick maneuver in the literature, this maneuver, remains controversial although recommended.
Hypothesis: The aim of this study is to assess the Sellick maneuver during rapid sequence induction in adults (pregnant women excluded) by comparing the incidence of lung aspiration whether this maneuver is applied or sham, in a noninferiority trial.
Primary endpoint: Incidence of lung aspiration
Secondary endpoints: Cormack and Lehane Grade , frequency of difficult intubation, frequency of impossible intubation, effect of releasing the Sellick maneuver on these three criteria, frequency of aspiration pneumonia within 24 hours, frequency of complications due to the Sellick maneuver (esophageal rupture and cricoid cartilage fracture rates) and mortality at day 28 or at hospital discharge.
Methods: This is a multicenter, randomized, double-blind, non-inferiority trial. We compare a group of patients benefiting from a rapid sequence induction without achieving the Sellick maneuver, where the movement is fake (sham group) with a group of patients undergoing a rapid sequence induction with effective execution of this maneuver (Sellick group). The two patient groups differ only by the effective or sham application of the Sellick maneuver .
In both arms, the Sellick maneuver , whether real or fake , can be released at the request of the person performing orotracheal intubation in particular to improve intubating conditions or in case of active vomiting. However, it should be kept in case of need for ventilation facemask.
Number of patients: The number of patients is estimated at 1 750 patients per group and so 3500 patients.
Inclusion criteria: patients older than 18 yr undergoing general anesthesia requiring rapid sequence induction (full stomach or presence of at least one risk factor for regurgitation of stomach content) are eligible.
Exclusion criteria: patients non consenting, pregnancy, contraindication to Sellick maneuver or succinylcholine, patients with predictive signs of bronchopneumonia during the preanesthetic consultation, patients with pulmonary contusion, upper respiratory tract abnormalities, laryngeal trauma, patients requiring an alternative to direct laryngoscopy, patients with troubles of consciousness, use of plastic single used laryngoscopic blade, use of rocuronium as neuromuscular blockade agent.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sham arm | Placebo comparator | Other: sham sellick maneuversham sellick maneuver |
| sellick arm | Experimental | Other: effective sellick maneuvereffective sellick maneuver |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients older than 18 yr undergoing general anaesthesia requiring rapid sequence induction (full stomach or presence of at least one risk factor for regurgitation of stomach content) are eligible.
- Obtain informed consent from the patient or a close relative/surrogate. Should such a person be absent, the patient will be randomized according to the specifications of emergency consent and the patient will be asked to give his/her consent for the continuation of the trial when his/her condition will allow.
Key exclusion criteria (12 listed)
- Non consent patients,
- Pregnancy,
- Contraindication to Sellick maneuver
- Contraindication to succinylcholine
- Patients with predictive signs of bronchopneumonia during the preanesthetic consultation ,
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 |
|---|---|---|
| effective sellick maneuverSellick maneuver is applied, as originally described by Sellick et al . | Other | sellick arm |
| sham sellick maneuverThe operator who applied the maneuver is the only person who knows the arm inclusion of the patient. Thus, he sets his fingers as described in Sellick arms without exerting pressure on the cricoid cartilage. | Other | sham arm |
Primary outcome
Incidence of lung aspiration
Time frame: Within 1 hour
in the operating room presence of gastric fluid on the vocal cords at the orotracheal intubation or in endotracheal suction when performed immediately after intubation
10 secondary outcomes
Cormack and Lehane Grade
Time frame: Within 1 hour
Frequency of use of a mask ventilation
Time frame: Within 1 hour
Number of times the Sellick maneuver should be discontinued
Time frame: Within 1 hour
Effects of releasing the Sellick maneuver on the conditions of tracheal intubation assessed by Cormack and Lehane grade
Time frame: Within 1 hour
Incidence of difficult and impossible intubation
Time frame: Within 1 hour
Incidence of aspiration pneumonia
Time frame: within the 24 hours
Incidence of oesophageal rupture
Time frame: day 28
Incidence of cricoid cartilage fracture
Time frame: day 28
Mortality
Time frame: day 28
Mortality
Time frame: Hospital discharge Hospital discharge if anterior at day 28
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 21 Dec 2018.
- Results publication: PubMed 30347104Birenbaum A, Hajage D, Roche S, Ntouba A, Eurin M, Cuvillon P, Rohn A, Compere V, Benhamou D, Biais M, Menut R, Benachi S, Lenfant F, Riou B; IRIS Investigators Group. Effect of Cricoid Pressure Compared With a Sham Procedure in the Rapid Sequence Induction of Anesthesia: The IRIS Randomized Clinical Trial. JAMA Surg. 2019 Jan 1;154(1):9-17. doi: 10.1001/jamasurg.2018.3577.
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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.
Aurelie Birenbaum, MD principal investigator
APHP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing effective sellick maneuver in people with Rapid Sequence Induction of General Anesthesia and Sellick Maneuver, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 12 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 21 Dec 2018. 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 France. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 lung aspiration (time frame: Within 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02080754, which also lists 1 linked publication.
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 21 Dec 2018.