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Comparison Between the Fastrach and CTrach Laryngeal Mask Airway

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ClinicalTrials.gov Identifier: NCT00814775
Recruitment Status : Terminated (recruitment challenges, device no longer available)
First Posted : December 25, 2008
Results First Posted : October 17, 2016
Last Update Posted : October 17, 2016
Sponsor:
Information provided by (Responsible Party):
The Cleveland Clinic

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.

Condition or disease Intervention/treatment
Intubation Device: Fastrach Laryngeal Mask Device: CTrach Laryngeal Mask

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Comparison Between the Fastrach and CTrach Laryngeal Mask Airway for Intubation of Patients With a Mallampati Score 3 or 4
Study Start Date : August 2008
Primary Completion Date : June 2010
Study Completion Date : June 2010

Arm Intervention/treatment
Active Comparator: Group 1
Fastrach Laryngeal Mask Airway intubation
Device: Fastrach Laryngeal Mask
Intubation of difficult airway using Fastrach Laryngeal Mask
Active Comparator: Group 2
Intubation of difficult airway using CTrach Laryngeal Mask
Device: CTrach Laryngeal Mask
CTrach Laryngeal Mask intubation



Primary Outcome Measures :
  1. 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: from start of intubation to successfully intubated ]
  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 Use of Fiberoptic Bronchoscopy [ Time Frame: 60 seconds ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00814775


Locations
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Investigators
Principal Investigator: Marco Maurtua, MD The Cleveland Clinic
Study Chair: Daniel I Sessler, MD The Cleveland Clinic

Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT00814775     History of Changes
Other Study ID Numbers: 08-358
First Posted: December 25, 2008    Key Record Dates
Results First Posted: October 17, 2016
Last Update Posted: October 17, 2016
Last Verified: August 2016

Keywords provided by The Cleveland Clinic:
Laryngeal mask
Difficult intubation