Sellick Maneuver Evaluation in Rapid Sequence Induction of General Anesthesia Non Inferiority Trial
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 3,472
- Locations
- 2
- Primary Endpoint
- Incidence of lung aspiration
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
sham arm
sham sellick maneuver
Intervention: sham sellick maneuver (Other)
sellick arm
effective sellick maneuver
Intervention: effective sellick maneuver (Other)
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Cormack and Lehane Grade(Within 1 hour)
- Number of times the Sellick maneuver should be discontinued(Within 1 hour)
- Incidence of difficult and impossible intubation(Within 1 hour)
- Incidence of aspiration pneumonia(within the 24 hours)
- Incidence of oesophageal rupture(day 28)
- Incidence of cricoid cartilage fracture(day 28)
- Effects of releasing the Sellick maneuver on the conditions of tracheal intubation assessed by Cormack and Lehane grade(Within 1 hour)
- Frequency of use of a mask ventilation(Within 1 hour)
- Mortality(Hospital discharge Hospital discharge if anterior at day 28)