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OpenTrials
Completed

NCT Number: NCT01091948

GlideScope Video Laryngoscope Versus Fiberoptic Intubation

Following informed consent, patients will be randomly assigned to oral fiberoptic intubation or to oral intubation using the GlideScope Video Laryngoscope. Following the induction of general anesthesia a sealed envelope would be opened to reveal the technique to be used. A stop watch will be started at the beginning of the procedure. At the completion of intubation the stop watch will be stopped and the time recorded along with other data. Based on a sample size estimation process, it is the investigators plan to study fifty patients. The two techniques will be compared in terms of the average time needed to place the endotracheal tube and studied using a two-sided T-Test with a significance level of 0.05. To ensure comparability between the two methods, all intubators will be required to have at experienced at least 10 uses of the GlideScope and 10 uses with fiberoptic intubation.

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Key information

Conditions

Oral Intubation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • at least 18 years old
  • scheduled for elective surgery requiring orotracheal intubation.

Exclusion criteria

  • known, difficult airway
  • loose teeth
  • pregnant
  • require a rapid sequence induction,
  • Body Mass Index under 30
  • unable to give consent
  • if special endotracheal tube (ETT) is needed for the case.

Treatment and study plan

Intubation with Fiberoptic laryngoscope

Device

Subjects will be intubated with the Fiberoptic laryngoscope.

Other names: Fiberoptic, laryngoscope

GlideScope® Video Laryngoscope

Device

Patients will be intubated with the GlideScope® Video Laryngoscope.

Other names: GlideScope®, Video Laryngoscope

Primary outcomes

  1. Time to Intubation (TTI) as Measured in Seconds

    Time frame: from start of intubation to successfully intubated up to 100 seconds

    Time from insertion of either the GlideScope or in the case of fibreoptic intubation, a Williams airway (SunMed, Largo, FL, USA) into the mouth, to the time when end-tidal PCO2 exceeded 2.7 kPa (20 mmHg).

Secondary outcomes

  1. Intubation Difficulty Score

    Time frame: from start of intubation to successfully intubated

    Intubation difficulty score is a 100-mm-long visual analogue scale (100 mm = extremely difficult);

  2. Successful Intubation on 1st Attempt

    Time frame: from start of first intubation to end of first intubation attempt

  3. Occurrence of Hypoxaemia

    Time frame: at 1 min prior to intubation, intubation, and 2, 4, 6, 8, and 10 min after

    Arterial oxygen saturation was recorded at 1 min prior to intubation, intubation, and 2, 4, 6, 8, and 10 min after; hypoxaemia was defined as occurrence of arterial oxygen saturation <90% at any of the above measurements.

  4. Trace Bleeding

    Time frame: Right after intubation

    Trace bleeding is a binary outcome: yes or no, which is determined based on amount of post-intubation bleeding present in the suction tube

  5. Sore Throat Grade

    Time frame: On the first postoperative day

  6. Number of Intubation Attempts

    Time frame: from start of intubation to successfully intubated

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Official study title

GlideScope Video Laryngoscope vs Fiberoptic Intubation

Important dates

Study start
2008
Primary completion
2009
Study completion
2010
First posted
Mar 24, 2010
Registry last updated
Dec 20, 2016

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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