Comparison Between the Fastrach and CTrach Laryngeal Mask Airway

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2010-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Intubation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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Group 1

Fastrach Laryngeal Mask Airway intubation

Group Type ACTIVE_COMPARATOR

Fastrach Laryngeal Mask

Intervention Type DEVICE

Intubation of difficult airway using Fastrach Laryngeal Mask

Group 2

Intubation of difficult airway using CTrach Laryngeal Mask

Group Type ACTIVE_COMPARATOR

CTrach Laryngeal Mask

Intervention Type DEVICE

CTrach Laryngeal Mask intubation

Interventions

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Fastrach Laryngeal Mask

Intubation of difficult airway using Fastrach Laryngeal Mask

Intervention Type DEVICE

CTrach Laryngeal Mask

CTrach Laryngeal Mask intubation

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No