Pentax Airway Scope (AWS) Intubation

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Device: Pentax AWS; Device: Macintosh laryngoscope

• Registration Number: NCT00667693
• Lead Sponsor: The Cleveland Clinic

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2008-04-24
• Study First Submitted QC: 2008-04-24
• Study First Posted: 2008-04-28
• Primary Completion: 2009-03
• Study Completion: 2009-03
• Results First Submitted: 2016-07-18
• Results First Submitted QC: 2016-09-13
• Results First Posted: 2016-10-31
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-23
• Last Update Posted: 2018-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pentax AWS	Pentax AWS	Intubation with a Pentax AWS
Macintosh laryngoscope	Macintosh laryngoscope	Intubation with a Macintosh laryngoscope

Primary Outcome Measures

Name	Time	Method
Time to Intubation	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 Outcome Measures

Name	Time	Method
The Number of Patients With Bleeding	From the start of intubation until 24 hours after surgery
Ease of Intubation	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
The Number of Patients With Different Number of Intubation Attempts	From the start of intubation until 24 hours after surgery	We summarized the number of patients with one, two or three intubation attempts.
Successful Intubation on the First Attempt	From the start of intubation until 24 hours after surgery	The count number of successful intubation on the first attempt

Trial Locations

Locations (1)

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States