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Completed

NCT Number: NCT01237080

Intubation of Morbidly Obese Patients. A Clinical Trial, Comparing Glide Scope ® With Fastrach TM

The purpose of this study is to compare the GlideScope ® and the Fastrach TM for intubation of morbidly obese. Mainly we will try to clarify which of the instruments that produce the shortest intubationtime and lowest number of intubationattempts.

The hypothesis is that intubation would be 1) quicker and 2) with the lowest number of attempts, using the GlideScope®.

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Key information

Conditions

Morbidly Obese Intubationattempts Intubationtime

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anesthesiology, Copenhagen University Hospital, Glostrup, Region Sjælland, Denmark

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About this study

The number of obese people rises. Thus 25.2% of Danish 9th graders are obese. As a result, surgery and anesthesia in obese patients becomes more frequent. Several potential problems related to anesthesia in this patient group exists, including airway management and sufficient oxygenation.

Anaesthesia of obese patients are more likely to require intubation. In light of the foregoing, it is therefore important to find the methods that provide the fewest complications related to intubation. Therefore this study compare two instruments (Fastrach TM and GlideScope ®) to find out which of the methods that provides the best airway management, measured primarily in time and numbers of intubation attempts.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • BMI >/= 35

Exclusion criteria

  • need for crash induction.

Treatment and study plan

Glidescope

Device

The GlideScope is an anatomically shaped, rigid, fibreoptic videolaryngoscope.

Fastrach

Device

The Fastrach is an intubation laryngeal mask.

Primary outcomes

  1. Number of Patients Intubated in the First Attempt

    Time frame: please see description

    The intubation attempt was considered a failure if the GS or the FT was removed from the patient's mouth and required reinsertion or if the cuff had been inflated and the tube needed to be replaced (e.g., in oesophageal intubation).

  2. Time to Intubate

    Time frame: From when the anaesthetist picked up the GS / FT until a typical capnogram was seen on the capnograph.

Secondary outcomes

  1. Lowest Saturation During Intubation.

    Time frame: measured on the monitor

  2. Mucosal Lesion

    Time frame: inspection during intubation and one hour postop.

  3. Subjectively Intubation Difficulty

    Time frame: measured immediately on a visual analogue scale.

  4. Intubation of the Esophagus.

    Time frame: detected immediately

  5. Postoperative Hoarseness.

    Time frame: one hour postoperative.

  6. Postoperative Throat Pain.

    Time frame: one hour postoperative

Sponsors and collaborators

Lead sponsor

Glostrup University Hospital, Copenhagen

Other

Registry information

Official study title

Intubation of Morbidly Obese Patients. A Randomized Clinical Trial, Comparing GlideScope ® With Fastrach TM.

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Nov 9, 2010
Registry last updated
Feb 20, 2013

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

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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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