Sellick Interest in Rapid Sequence Induction

NCT02080754 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 3472

Last updated 2018-12-21

No results posted yet for this study

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.

Conditions

  • Rapid Sequence Induction of General Anesthesia
  • Sellick Maneuver
  • Acid Aspiration Syndrome
  • Lung Aspiration
  • Aspiration Pneumonia

Interventions

OTHER

effective sellick maneuver

Sellick maneuver is applied, as originally described by Sellick et al .

OTHER

sham sellick maneuver

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.

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Aurelie Birenbaum, MD · APHP

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-04
Primary Completion
2017-02-28
Completion
2017-07-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02080754 on ClinicalTrials.gov