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Completed

NCT Number: NCT00667693

Pentax Airway Scope (AWS) Intubation

This study will compare the Macintosh laryngoscope with the Pentax. The Pentax AWS is a novel airway management device that is designed to facilitate laryngoscopy and endotracheal intubation.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

About this study

100 obese patients (BMI 30 to 50) requiring orotracheal intubation for elective surgery will be randomly allocated to intubation with either a conventional Macintosh laryngoscope or with the Pentax AWS. Our study hypothesis is that use of Pentax AWS will make tracheal intubation easier to perform in the obese surgical patient (BMI 30 to 50), as evidenced by the time to complete the intubation process as well as an "Ease of Use" visual analog score (VAS) measure.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • subject is at least 18 years old
  • BMI between 30 and 50
  • scheduled for elective surgery requiring orotracheal intubation

Exclusion criteria

  • a known difficult airway
  • loose teeth
  • subject pregnancy
  • rapid sequence induction required
  • subject is unable to give consent
  • anesthesiologist considered use of the Pentax AWS to be contraindicated
  • special endotracheal tube (ETT) is needed for the case.

Treatment and study plan

Macintosh laryngoscope

Device

Intubation with Macintosh laryngoscope

Pentax AWS

Device

Intubation with Pentax AWS

Primary outcomes

  1. Time to Intubation

    Time frame: time between sufficient muscle relaxant and placement of intubation tube, up to 100 seconds

    time between sufficient muscle relaxant and placement of intubation tube

Secondary outcomes

  1. Ease of Intubation

    Time frame: From the start of intubation until 24 hours after surgery

    Ease of intubation was recorded by the operator immediately after intubation on a 100 mm visual analog scale (VAS). The score ranges from 0 to 100. A higher score indicates more difficulty in intubation

  2. Successful Intubation on the First Attempt

    Time frame: From the start of intubation until 24 hours after surgery

    The count number of successful intubation on the first attempt

  3. The Number of Patients With Different Number of Intubation Attempts

    Time frame: From the start of intubation until 24 hours after surgery

    We summarized the number of patients with one, two or three intubation attempts.

  4. The Number of Patients With Bleeding

    Time frame: From the start of intubation until 24 hours after surgery

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Official study title

A Randomized Comparison Between the Pentax AWS Video Laryngoscope and the Macintosh Laryngoscope

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Apr 28, 2008
Registry last updated
Jul 24, 2018

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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