Comparison Between the Fastrach and CTrach Laryngeal Mask Airway

This study has been terminated.
(recruitment challenges, device no longer available)
Sponsor:
Information provided by:
Outcomes Research Consortium
ClinicalTrials.gov Identifier:
NCT00814775
First received: December 23, 2008
Last updated: September 3, 2010
Last verified: September 2010
  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:

  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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014