Clinical Trial: Sellick Interest in Rapid Sequence Induction

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Sellick Maneuver Evaluation in Rapid Sequence Induction of General Anesthesia Non Inferiority Trial

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 Summary:

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.

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



Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Cormack and Lehane Grade [ Time Frame: Within 1 hour ]
    During orotracheal intubation
  • Frequency of use of a mask ventilation [ Time Frame: Within 1 hour ]
    In the operating room, if needed, the mask ventilation will be recorded
  • Number of times the Sellick maneuver should be discontinued [ Time Frame: Within 1 hour ]
    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 [ Time Frame: Within 1 hour ]
    During orotracheal intubation
  • Incidence of difficult and impossible intubation [ Time Frame: Within 1 hour ]
    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 [ Time Frame: within the 24 hours ]
    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 [ Time Frame: day 28 ]
    This complication is extremely rare and clinically very telling. No further review is planned to diagnose it
  • Incidence of cricoid cartilage fracture [ Time Frame: day 28 ]
    This complication is extremely rare and clinically very telling. No further review is planned to diagnose it.
  • Mortality [ Time Frame: day 28 ]
  • Mortality [ Time Frame: Hospital discharge Hospital discharge if anterior at day 28 ]


Original Secondary Outcome: Same as current

Information By: Assistance Publique - Hôpitaux de Paris

Dates:
Date Received: February 17, 2014
Date Started: January 2014
Date Completion: January 2018
Last Updated: September 28, 2016
Last Verified: September 2016