Sellick Interest in Rapid Sequence Induction (IRIS)
Primary Purpose
Rapid Sequence Induction of General Anesthesia, Sellick Maneuver, Acid Aspiration Syndrome
Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
effective sellick maneuver
sham sellick maneuver
Sponsored by
About this trial
This is an interventional prevention trial for Rapid Sequence Induction of General Anesthesia focused on measuring Crush induction, Cricoid pressure, Sellick maneuver, Lung aspiration, Aspiration pneumonia
Eligibility Criteria
Inclusion criteria :
- 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.
Exclusion criteria :
- 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
- 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
Sites / Locations
- Groupe Hospitalier Pitié Salpetriere
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
sham arm
sellick arm
Arm Description
sham sellick maneuver
effective sellick maneuver
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Cormack and Lehane Grade
During orotracheal intubation
Frequency of use of a mask ventilation
In the operating room, if needed, the mask ventilation will be recorded
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)
Effects of releasing the Sellick maneuver on the conditions of tracheal intubation assessed by Cormack and Lehane grade
During orotracheal intubation
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.
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
Incidence of oesophageal rupture
This complication is extremely rare and clinically very telling. No further review is planned to diagnose it
Incidence of cricoid cartilage fracture
This complication is extremely rare and clinically very telling. No further review is planned to diagnose it.
Mortality
Mortality
Full Information
NCT ID
NCT02080754
First Posted
February 17, 2014
Last Updated
December 20, 2018
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT02080754
Brief Title
Sellick Interest in Rapid Sequence Induction
Acronym
IRIS
Official Title
Sellick Maneuver Evaluation in Rapid Sequence Induction of General Anesthesia Non Inferiority Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
February 4, 2014 (Actual)
Primary Completion Date
February 2017 (Actual)
Study Completion Date
July 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
3472 (Actual)
8. Arms, Groups, and Interventions
Arm Title
sham arm
Arm Type
Placebo Comparator
Arm Description
sham sellick maneuver
Arm Title
sellick arm
Arm Type
Experimental
Arm Description
effective sellick maneuver
Intervention Type
Other
Intervention Name(s)
effective sellick maneuver
Intervention Description
Sellick maneuver is applied, as originally described by Sellick et al .
Intervention Type
Other
Intervention Name(s)
sham sellick maneuver
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence of lung aspiration
Description
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
Time Frame
Within 1 hour
Secondary Outcome Measure Information:
Title
Cormack and Lehane Grade
Description
During orotracheal intubation
Time Frame
Within 1 hour
Title
Frequency of use of a mask ventilation
Description
In the operating room, if needed, the mask ventilation will be recorded
Time Frame
Within 1 hour
Title
Number of times the Sellick maneuver should be discontinued
Description
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)
Time Frame
Within 1 hour
Title
Effects of releasing the Sellick maneuver on the conditions of tracheal intubation assessed by Cormack and Lehane grade
Description
During orotracheal intubation
Time Frame
Within 1 hour
Title
Incidence of difficult and impossible intubation
Description
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.
Time Frame
Within 1 hour
Title
Incidence of aspiration pneumonia
Description
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
Time Frame
within the 24 hours
Title
Incidence of oesophageal rupture
Description
This complication is extremely rare and clinically very telling. No further review is planned to diagnose it
Time Frame
day 28
Title
Incidence of cricoid cartilage fracture
Description
This complication is extremely rare and clinically very telling. No further review is planned to diagnose it.
Time Frame
day 28
Title
Mortality
Time Frame
day 28
Title
Mortality
Time Frame
Hospital discharge Hospital discharge if anterior at day 28
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria :
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.
Exclusion criteria :
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aurelie Birenbaum, MD
Organizational Affiliation
APHP
Official's Role
Principal Investigator
Facility Information:
Facility Name
Groupe Hospitalier Pitié Salpetriere
City
Paris
ZIP/Postal Code
75013
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
30347104
Citation
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. Erratum In: JAMA Surg. 2019 Jan 1;154(1):96.
Results Reference
result
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