Comparison Between the Fastrach and CTrach Laryngeal Mask Airway

Comparison Between the Fastrach and CTrach Laryngeal Mask Airway for Intubation of Patients With a Mallampati Score 3 or 4

The purpose of this study is to determine the effectiveness of the Fastrach and the CTrach Laryngeal mask airway to achieve placement of a breathing tube in the windpipe of patients where this may be difficult.

Study Overview

• Status: Terminated
• Conditions: Intubation
• Intervention / Treatment: Device: Fastrach Laryngeal Mask; Device: CTrach Laryngeal Mask

Detailed Description

Participant will be randomly assigned to receive one of 2 conventional airway devices - the Fastrach Laryngeal Mask Airway or the CTrach Laryngeal Mask Airway. This study will compare the time required for successful intubation between the two devices.

Postoperative visit will be performed to assess the participant's clinical condition and to receive participant's feed back.

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients with an ASA score of 1-3.
2. Scheduled for elective surgical procedure
3. Age 18 and above
4. Patients with Mallampati airway classification scores III and IV

Exclusion Criteria:

1. Current pregnancy
2. Patients undergoing brain aneurysm clipping brain arteriovenous malformation surgery or vascular surgery procedures
3. Patients with obstructive sleep apnea or with a history of difficult ventilation
4. Mouth opening less than 3 cm.
5. Patients with indication for awake fiberoptic intubation or with a history of difficult intubation
6. Patients with cancer of the neck or the upper airway
7. Emergent surgery, patients requiring rapid sequence induction
8. Patients with severe gastroesophageal reflux
9. Patients with severe cardiac, pulmonary, hepatic or renal co-morbidities. 10. Patients unable to consent their participation in the study.

Study Plan

How is the study designed?

Design Details

• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Group 1; Fastrach Laryngeal Mask Airway intubation	Device: Fastrach Laryngeal Mask; Intubation of difficult airway using Fastrach Laryngeal Mask
ACTIVE_COMPARATOR: Group 2; Intubation of difficult airway using CTrach Laryngeal Mask	Device: CTrach Laryngeal Mask; CTrach Laryngeal Mask intubation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To Compare the Time Required for Successful Intubation Between the Fastrach and CTrach LMA Devices in Patients With a Mallampati Score III and IV Without Use of Fiberoptic Bronchoscopy	from start of intubation to successfully intubated
To Compare the Time Required for Successful Intubation Between the Fastrach and CTrach LMA Devices in Patients With a Mallampati Score III and IV Use of Fiberoptic Bronchoscopy	60 seconds

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Investigators: Principal Investigator: Marco Maurtua, MD, The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start: August 1, 2008
• Primary Completion (ACTUAL): June 1, 2010
• Study Completion (ACTUAL): June 1, 2010

Study Registration Dates

• First Submitted: December 23, 2008
• First Submitted That Met QC Criteria: December 23, 2008
• First Posted (ESTIMATE): December 25, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): October 17, 2016
• Last Update Submitted That Met QC Criteria: August 22, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: Difficult intubation; Laryngeal mask
• Other Study ID Numbers: 08-358