Study Stopped
recruitment challenges, device no longer available
Comparison Between the Fastrach and CTrach Laryngeal Mask Airway
1 other identifier
interventional
43
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2008
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2008
CompletedFirst Submitted
Initial submission to the registry
December 23, 2008
CompletedFirst Posted
Study publicly available on registry
December 25, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2010
CompletedResults Posted
Study results publicly available
October 17, 2016
CompletedOctober 17, 2016
August 1, 2016
1.8 years
December 23, 2008
June 20, 2016
August 22, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Study Arms (2)
Group 1
ACTIVE COMPARATORFastrach Laryngeal Mask Airway intubation
Group 2
ACTIVE COMPARATORIntubation of difficult airway using CTrach Laryngeal Mask
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Results Point of Contact
- Title
- Roberta Johnson
- Organization
- Cleveland Clinic
Study Officials
- PRINCIPAL INVESTIGATOR
Marco Maurtua, MD
The Cleveland Clinic
- STUDY CHAIR
Daniel I Sessler, MD
The Cleveland Clinic
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 23, 2008
First Posted
December 25, 2008
Study Start
August 1, 2008
Primary Completion
June 1, 2010
Study Completion
June 1, 2010
Last Updated
October 17, 2016
Results First Posted
October 17, 2016
Record last verified: 2016-08