NCT02080754|CompletedPhase 3DMC
Sellick Interest in Rapid Sequence Induction
IRIS
Sellick Maneuver Evaluation in Rapid Sequence Induction of General Anesthesia Non Inferiority Trial
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Sponsor study identifier
Secondary identifiers
OTHER · IDRCB
interventional
3,472
1 country
1
Study Start
February 4, 2014
Actual (reported)Primary Completion
February 2017
Actual (reported)Study Completion
July 2017
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2017
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 4, 2014
Actual (reported)February 17, 2014
Actual (reported)March 6, 2014
Actual (reported)February 2017
Actual (reported)July 2017
Actual (reported)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
Within 1 hour
Cormack and Lehane Grade
Within 1 hour
Frequency of use of a mask ventilation
Within 1 hour
sham sellick maneuver
effective sellick maneuver
Sellick maneuver is applied, as originally described by Sellick et al .
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.
Groupe Hospitalier Pitié Salpetriere
Paris, 75013, France
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.
Aurelie Birenbaum, MD
APHP
3,472 participants (actual enrollment reported by the registry).
First Submitted
February 17, 2014
First Posted
March 6, 2014
Study Start
February 4, 2014
Actual (reported)Early Stop(Ruling) of the Antibiotic Treatment During Pneumopathies d' Inhalation
Number of times the Sellick maneuver should be discontinued
Within 1 hour
Effects of releasing the Sellick maneuver on the conditions of tracheal intubation assessed by Cormack and Lehane grade
Within 1 hour
Incidence of difficult and impossible intubation
Within 1 hour
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
February 2017
Actual (reported)Study Completion
July 2017
Actual (reported)Last Updated
December 21, 2018
Record last verified: 2017-11
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Source: ClinicalTrials.gov.
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