Comparison Between the Fastrach and CTrach Laryngeal Mask Airway

Intubation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00814775
• Other study ID #: 08-358
• Status: Terminated
• Phase: N/A
• First received: December 23, 2008
• Last updated: September 3, 2010
• Start date: August 2008
• Est. completion date: June 2010

Study information

• Verified date: September 2010
• Source: Outcomes Research Consortium
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 43
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Intubation

Intervention

Device:
• Fastrach Laryngeal Mask
Intubation of difficult airway using Fastrach Laryngeal Mask
• CTrach Laryngeal Mask
CTrach Laryngeal Mask intubation

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Outcomes Research Consortium

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		60 seconds	No
Secondary	To gather pilot information that may determine if five airway risk predictors correlate with difficult ventilation or intubation, using these airway devices		60 seconds	No