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OpenTrials
Completed

NCT Number: NCT00917033

Tracheal Intubation of Morbidly Obese Patients. GlideScope Versus Direct Laryngoscopy

The purpose of this study is to examine whether orotracheal intubation in morbidly obese patients is faster, gentler and safer using the GlideScope videolaryngoscope than with the Macintosh direct laryngoscope.

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Key information

Conditions

Intubation, Endotracheal Anesthesia, General Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Anesthesia, Glostrup University Hospital

Copenhagen, Glostrup, DK-2600, Denmark

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Approved for elective bariatric surgery at Glostrup University Hospital, Copenhagen.
  • Body Mass Index at least 35 kg/m2
  • Written informed consent to participate

Exclusion criteria

  • Mental illness
  • Abuse of alcohol or other substances
  • Previous difficult tracheal intubation
  • Considered non-eligible for safety-reasons by the anesthetist in charge

Treatment and study plan

Glidescope

Device

Orotracheal intubation

Macintosh direct laryngoscope

Device

Orotracheal intubation

Primary outcomes

  1. Time to intubate

    Time frame: Measured during intubation (seconds)

Secondary outcomes

  1. Number of intubation attempts

    Time frame: Measured during intubation (seconds)

  2. Lowest arterial oxygen saturation during intubation

    Time frame: Measured during intubation (seconds)

  3. Subjective difficulty of intubation

    Time frame: Measured during intubation (seconds)

  4. Cormack-Lehane Score

    Time frame: Measured during intubation (seconds)

  5. Airway mucosal trauma

    Time frame: Measured during intubation (seconds)

  6. Dental injury

    Time frame: Measured during intubation (seconds)

  7. Post-procedure sore throat

    Time frame: One hour post-operative

  8. Post-procedure hoarseness of voice

    Time frame: One hour post-operative

Sponsors and collaborators

Lead sponsor

Glostrup University Hospital, Copenhagen

Other

Registry information

Official study title

Orotracheal Intubation of Morbidly Obese Patients. A Randomised Controlled Trial Comparing the GlideScope Videolaryngoscope to the Macintosh Direct Laryngoscope.

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jun 10, 2009
Registry last updated
Feb 24, 2010

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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