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NCT Number: NCT01357824

Fibreoptic Intubation With and Without Sellick´s Maneuver

The goal of this study is to evaluate the effect of Sellick´s Maneuver, a firm pressure on the throat, just below the Adams apple, to occlude the esophagus, in order to prevent aspiration of gastric contents, on intubation with a flexible fiberscope. The result of this study will be participate in the discussion of the importance of Sellick´s Maneuver.

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Key information

Conditions

Intubation Intraesophageal Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases Laryngopharyngeal Reflux Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Aspiration Respiratory Aspiration of Gastric Contents Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Operations- og Anæstesilogisk afd Y, Glostrup Hospital

Glostrup Municipality, 2600, Denmark

About this study

The patients included in this study has volunteered after sufficient information, and must be ASA-class I-II, 18 years or more, and must not have indications for a rapid sequence induction.

The patient will be intubated twice, with and without Sellick´s maneuver. It is blinded to the intubating physician, in which order this pressure is applied.

The outcomes measures will be time of intubation, oxygen saturation before and after intubation and a Cormack Scale graduation of the visibility of the vocal cords. The intubation will be failed, if it cannot be performed under 120 seconds, or if the patients desaturate to 95% or less.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ASA I-II
  • Informed consent to participate in the study
  • Age 18 or older
  • Predicted difficult airways

Exclusion criteria

  • Body mass index more then 35
  • Patients with an indication for a rapid sequence induction (reflux, Hiatus herniation, Gastric bypass)

Treatment and study plan

Application of Sellick´s maneuver.

Procedure

The patient will be intubated with a flexible fiberscope, Olympus model, under the application of Sellick´s maneuver, with the recommended 30 Newtons pressure, and also, as control, be intubated with a sham Sellick´s maneuver, with 0 Newton. The order of the pressures is randomized, and it is blinded to the intubating physician by a cloth which of the maneuvers that is used. The pressure is measured be a pediatric cuff, which is pressed against the throat.

Primary outcomes

  1. Time of intubation

    Time frame: 180 seconds

    The investigators will find an eventually change in the time of intubation with and without Sellick´s Maneuver

Secondary outcomes

  1. Number of patients that cannot be intubated after 120 sec. with and without Sellick´s maneuver

    Time frame: 180 seconds

    Patients that is not intubated after 120 seconds in each trial, will count as "not intubated after 120 seconds".

  2. Fall of oxygen saturation after intubation with and without Sellick´s maneuver.

    Time frame: 180 seconds

    The investigators measure the oxygen saturation on a finger device at the beginning and the and of the intubations.

  3. Visualization of the vocal cords

    Time frame: 180 seconds

    The investigators will observe the visualization of the vocal cords, and provide the result on the Cormack Score.

Sponsors and collaborators

Lead sponsor

Glostrup University Hospital, Copenhagen

Other

Registry information

Official study title

View af Larynx and Intubation With a Flexible Fibreoptic Scope With and Without Sellick´s Maneuver.

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
May 23, 2011
Registry last updated
Jan 31, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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