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Comparison Between the Fastrach and CTrach Laryngeal Mask Airway

NeuroTherapia, Inc. logo

NeuroTherapia, Inc.

Status

Terminated

Conditions

Intubation

Treatments

Device: Fastrach Laryngeal Mask
Device: CTrach Laryngeal Mask

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

43 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

43 participants in 2 patient groups

Group 1
Active Comparator group
Description:
Fastrach Laryngeal Mask Airway intubation
Treatment:
Device: Fastrach Laryngeal Mask
Group 2
Active Comparator group
Description:
Intubation of difficult airway using CTrach Laryngeal Mask
Treatment:
Device: CTrach Laryngeal Mask

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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