Pentax Airway Scope (AWS) Intubation

NeuroTherapia, Inc.

Status: Completed

Conditions: Obesity

Treatments: Device: Pentax AWS; Device: Macintosh laryngoscope

Study type: Interventional

Funder types: Other

Identifiers

NCT00667693

08-046

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 101 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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101 participants in 2 patient groups

Macintosh laryngoscope

Active Comparator group

Description:

Intubation with a Macintosh laryngoscope

Treatment:

Device: Macintosh laryngoscope

Pentax AWS

Active Comparator group

Description:

Intubation with a Pentax AWS

Treatment:

Device: Pentax AWS