Sellick Interest in Rapid Sequence Induction (IRIS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT02080754
First received: February 17, 2014
Last updated: March 4, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Rapid Sequence Induction of General Anesthesia
Sellick Maneuver
Acid Aspiration Syndrome
Lung Aspiration
Aspiration Pneumonia
Other: effective sellick maneuver
Other: sham sellick maneuver
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Sellick Maneuver Evaluation in Rapid Sequence Induction of General Anesthesia Non Inferiority Trial

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Incidence of lung aspiration [ Time Frame: Within 1 hour ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Within 1 hour ] [ Designated as safety issue: Yes ]
    During orotracheal intubation

  • Frequency of use of a mask ventilation [ Time Frame: Within 1 hour ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    During orotracheal intubation

  • Incidence of difficult and impossible intubation [ Time Frame: Within 1 hour ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    This complication is extremely rare and clinically very telling. No further review is planned to diagnose it.

  • Mortality [ Time Frame: day 28 ] [ Designated as safety issue: Yes ]
  • Mortality [ Time Frame: Hospital discharge Hospital discharge if anterior at day 28 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 3500
Study Start Date: January 2014
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: sham arm
sham sellick maneuver
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.
Experimental: sellick arm
effective sellick maneuver
Other: effective sellick maneuver
Sellick maneuver is applied, as originally described by Sellick et al .

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02080754

Contacts
Contact: Aurelie Birenbaum, MD +33142177532 titibiran@gmail.com

Locations
France
Groupe Hospitalier Pitié Salpetriere Recruiting
Paris, France, 75013
Contact: Aurelie Birenbaum, MD    +33142177532      
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Aurelie Birenbaum, MD APHP
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02080754     History of Changes
Other Study ID Numbers: P 120120, 2013-A00624-41
Study First Received: February 17, 2014
Last Updated: March 4, 2014
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Crush induction
Cricoid pressure
Sellick maneuver
Lung aspiration
Aspiration pneumonia

Additional relevant MeSH terms:
Pneumonia
Pneumonia, Aspiration
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on September 18, 2014