Comparison Between the Fastrach and CTrach Laryngeal Mask Airway - Full Text View

Sponsor:	Outcomes Research Consortium
Information provided by:	Outcomes Research Consortium
ClinicalTrials.gov Identifier:	NCT00814775

Purpose

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.

Condition	Intervention
Intubation	Device: Fastrach Laryngeal Mask Device: CTrach Laryngeal Mask

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label
Official Title:	Comparison Between the Fastrach and CTrach Laryngeal Mask Airway for Intubation of Patients With a Mallampati Score 3 or 4

Further study details as provided by Outcomes Research Consortium:

Primary Outcome Measures:

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 [ Time Frame: 60 seconds ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To gather pilot information that may determine if five airway risk predictors correlate with difficult ventilation or intubation, using these airway devices [ Time Frame: 60 seconds ] [ Designated as safety issue: No ]

Enrollment:	43
Study Start Date:	August 2008
Study Completion Date:	June 2010
Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Group 1 Fastrach Laryngeal Mask Airway intubation	Device: Fastrach Laryngeal Mask Intubation of difficult airway using Fastrach Laryngeal Mask Other Name: Fastrach Laryngeal Mask
Active Comparator: Group 2 Intubation of difficult airway using CTrach Laryngeal Mask	Device: CTrach Laryngeal Mask CTrach Laryngeal Mask intubation

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00814775

Locations

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

Sponsors and Collaborators

Outcomes Research Consortium

Investigators

Principal Investigator:	Marco Maurtua, MD	The Cleveland Clinic
Study Chair:	Daniel I Sessler, MD	The Cleveland Clinic

More Information

No publications provided

Responsible Party:	Marco Maurtua, M.D., Cleveland Clinic
ClinicalTrials.gov Identifier:	NCT00814775 History of Changes
Other Study ID Numbers:	08-358
Study First Received:	December 23, 2008
Last Updated:	September 3, 2010
Health Authority:	United States: Institutional Review Board

Keywords provided by Outcomes Research Consortium:

Laryngeal mask
Difficult intubation

ClinicalTrials.gov processed this record on February 09, 2012