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

December 23, 2008
September 3, 2010
August 2008
June 2010   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00814775 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Comparison Between the Fastrach and CTrach Laryngeal Mask Airway
Comparison Between the Fastrach and CTrach Laryngeal Mask Airway for Intubation of Patients With a Mallampati Score 3 or 4

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Intubation
  • Device: Fastrach Laryngeal Mask
    Intubation of difficult airway using Fastrach Laryngeal Mask
    Other Name: Fastrach Laryngeal Mask
  • Device: CTrach Laryngeal Mask
    CTrach Laryngeal Mask intubation
  • Active Comparator: Group 1
    Fastrach Laryngeal Mask Airway intubation
    Intervention: Device: Fastrach Laryngeal Mask
  • Active Comparator: Group 2
    Intubation of difficult airway using CTrach Laryngeal Mask
    Intervention: Device: CTrach Laryngeal Mask
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
43
June 2010
June 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00814775
08-358
No
Marco Maurtua, M.D., Cleveland Clinic
Outcomes Research Consortium
Not Provided
Principal Investigator: Marco Maurtua, MD The Cleveland Clinic
Study Chair: Daniel I Sessler, MD The Cleveland Clinic
Outcomes Research Consortium
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP