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Completed

NCT Number: NCT01635179

Laryngeal View With Videolaryngoscopy

To prevent bronchial aspiration during induction of anaesthesia it has been a common procedure to perform a cricoid pressure, called Sellicks Maneuver, to occlude esophagus, and thereby prevent aspiration. During the last ten years the efficiency of this maneuver has been discussed, since it probably prolong the intubation time and do not significantly reduces the risk of aspiration.

The hypothesis is that Sellicks Maneuver prolong the time of intubation and reduces the view of the laryngeal inlet, during intubation with a videolaryngoscopy.

The hypothesis is tested by a double-blinded randomized study where patients is intubated twice, with and without Sellicks Maneuver, in a randomized order. The specific cricoid pressure is blinded to the personal performing the intubation.

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Key information

Conditions

Respiratory Aspiration Hypoxemia Hypoxia Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Glostrup University Hospital

Glostrup Municipality, 2600, Denmark

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • ASA 1-2, BMI < 35,
  • no indication for rapid sequence induction,
  • age > 18,
  • able to give consent.

Exclusion criteria

  • ASA > 2,
  • BMI > 35,
  • RSI

Treatment and study plan

Cricoid Pressure

Procedure

The patient is intubated twice, once with a cricoid pressure and once with a sham-pressure, when performing a videolaryngoscopy.

Other names: Sellicks maneuver., Profylaxis of bronchial aspiration

Primary outcomes

  1. Completed intubation within 120 seconds

    Time frame: 120 seconds

    The primary outcome measure is the rate of completed and failed intubations. A intubations is failed when the oxygen saturation is less then 95% or the intubation time is longer then 120 seconds.

Secondary outcomes

  1. A description of the laryngeal inlet

    Time frame: 120 seconds

    The secondary outcome measure is a description of the laryngeal inlet according the the Cormack-Lehan system, and how Sellicks Maneuver alters that view.

Sponsors and collaborators

Lead sponsor

Glostrup University Hospital, Copenhagen

Other

Registry information

Official study title

Laryngeal View With Intubation by Videolaryngoscopy With and Without Sellicks Maneuver.

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jul 9, 2012
Registry last updated
Apr 25, 2013

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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