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Clinical Trials/NCT03341507
NCT03341507
Completed
Not Applicable

A Comparative Study Between the Rigid Tube for Laryngoscopy, as a New Tool for Tracheal Intubation, and McIntosh Laryngoscope in Difficult Airway Patients

Iuliu Hatieganu University of Medicine and Pharmacy1 site in 1 country64 target enrollmentFebruary 1, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Intubation;Difficult
Sponsor
Iuliu Hatieganu University of Medicine and Pharmacy
Enrollment
64
Locations
1
Primary Endpoint
Time to Tracheal Intubation With the Rigid Tube
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

This study evaluates the efficiency of the rigid tube for laryngoscopy for tracheal intubation in patients with presumed difficult airway and compare the classical laryngoscopy and this method in matter of glottis visualisation and tracheal intubation.

Detailed Description

The rigid tube for laryngoscopy is a 15 to 30 cm long metallic tube with a bevel end and a diameter of 0.5-2.0 cm , an instrument used to inspect the larynx and surrounding areas. It resembles a rigid bronchoscope but it is shorter. When in use, it has to be attached to a light source. The hypothesis of the study stands that the rigid tube for laryngoscopy could be more efficient in tracheal intubation for difficult airway patients when the classical intubation with a curved blade laryngoscope is unsatisfactory. The retromolar approach in both sides together with bougie(intubating tube introducer) intubation is the technique of intubation used in this study.

Registry
clinicaltrials.gov
Start Date
February 1, 2017
End Date
December 7, 2019
Last Updated
5 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Iuliu Hatieganu University of Medicine and Pharmacy
Responsible Party
Principal Investigator
Principal Investigator

Marchis Ioan Florin

Principal Investigator

Iuliu Hatieganu University of Medicine and Pharmacy

Eligibility Criteria

Inclusion Criteria

  • patients with criteria of anatomically difficult airway from SARI (The Simplified Airway Risk Index Scale) parameters analysis
  • patients with airway pathology which predicted difficult intubation: tumors or cervical masses, previous radiotherapy or surgery

Exclusion Criteria

  • stridor or marked laryngeal or tracheal stenosis, vocal cords polyps
  • emergency surgery, decompensated cardiac or pulmonary disease
  • grade 1 and 2a at classical laryngoscopy after Cormack- Lehane Classification

Outcomes

Primary Outcomes

Time to Tracheal Intubation With the Rigid Tube

Time Frame: 120 seconds

the time from starting to use the rigid tube for laryngoscopy until the airway was secured.

Secondary Outcomes

  • Complications During Intubation With Rigid Tube(5 minutes)
  • Late Complications of Intubation With Rigid Tube(3 days)

Study Sites (1)

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