Tracheal Intubation With the Rigid Tube for Laryngoscopy- a New Method

Not Applicable

Completed

• Conditions: Intubation;Difficult
• Interventions: Device: classical laryngoscopy; Device: rigid tube for laryngoscopy

• Registration Number: NCT03341507
• Lead Sponsor: Iuliu Hatieganu University of Medicine and Pharmacy

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.

Study Timeline

• Study Start: 2017-02-01
• Study First Submitted: 2017-11-03
• Study First Submitted QC: 2017-11-12
• Study First Posted: 2017-11-14
• Results First Submitted: 2019-08-07
• Primary Completion: 2019-12-01
• Study Completion: 2019-12-07
• Results First Submitted QC: 2021-02-11
• Status Verified: 2021-03
• Results First Posted: 2021-03-08
• Last Update Submitted: 2021-03-16
• Last Update Posted: 2021-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
laryngoscopy and tracheal intubation	classical laryngoscopy	Tracheal intubation with the rigid tube for laryngoscopy for patients with difficult airway. Prior the use of rigid tube for laryngoscopy, a classical laryngoscopy with a McIntosh laryngoscope will be performed.
laryngoscopy and tracheal intubation	rigid tube for laryngoscopy	Tracheal intubation with the rigid tube for laryngoscopy for patients with difficult airway. Prior the use of rigid tube for laryngoscopy, a classical laryngoscopy with a McIntosh laryngoscope will be performed.

Primary Outcome Measures

Name	Time	Method
Time to Tracheal Intubation With the Rigid Tube	120 seconds	the time from starting to use the rigid tube for laryngoscopy until the airway was secured.

Secondary Outcome Measures

Name	Time	Method
Complications During Intubation With Rigid Tube	5 minutes	complications noticed during the use of rigid tube - hypoxia defined as oxygen saturation less than 80%
Late Complications of Intubation With Rigid Tube	3 days	complications noticed following the use of rigid tube - sore throat, upper lip injury.

Trial Locations

Locations (1)

Cluj County Emergency Hospital- ENT Clinic; 🇷🇴 Cluj Napoca, Cluj, Romania