Comparison Between the Fastrach and CTrach Laryngeal Mask Airway

Not Applicable

Terminated

• Conditions: Intubation
• Interventions: Device: CTrach Laryngeal Mask; Device: Fastrach Laryngeal Mask

• Registration Number: NCT00814775
• Lead Sponsor: The Cleveland Clinic

Brief Summary

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.

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 Timeline

• Study Start: 2008-08
• Study First Submitted: 2008-12-23
• Study First Submitted QC: 2008-12-23
• Study First Posted: 2008-12-25
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Results First Submitted: 2016-06-20
• Status Verified: 2016-08
• Results First Submitted QC: 2016-08-22
• Last Update Submitted: 2016-08-22
• Results First Posted: 2016-10-17
• Last Update Posted: 2016-10-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 43

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2	CTrach Laryngeal Mask	Intubation of difficult airway using CTrach Laryngeal Mask
Group 1	Fastrach Laryngeal Mask	Fastrach Laryngeal Mask Airway intubation

Primary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States