Skip to main content
OpenTrials
Completed

NCT Number: NCT03341507

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Intubation;Difficult

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cluj County Emergency Hospital- ENT Clinic

Cluj-Napoca, Cluj, 400006, Romania

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

classical laryngoscopy

Device

the laryngoscopy with the McIntosh laryngoscope performed prior the use of rigid tube and the Cormack-Lehane glottis visualisation noted.

Other names: laryngoscopy with McIntosh curved blade laryngoscope

rigid tube for laryngoscopy

Device

the view of glottis achieved with the rigid tub for laryngoscopy and tracheal intubation with an elastic gum bougie performed

Primary outcomes

  1. 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

  1. Complications During Intubation With Rigid Tube

    Time frame: 5 minutes

    complications noticed during the use of rigid tube - hypoxia defined as oxygen saturation less than 80%

  2. Late Complications of Intubation With Rigid Tube

    Time frame: 3 days

    complications noticed following the use of rigid tube - sore throat, upper lip injury.

Other outcomes

  1. Conventional Laryngoscopy With the Curved Blade Laryngoscope ( MacIntosh) and Tracheal Intubation With the Curved Blade Laryngoscope if the Cormack-Lehane Glottis View Grade is 1 or 2a.

    Time frame: 60 seconds

    Conventional laryngoscopy was performed with a MacIntosh curved blade laryngoscope, and the Cormack-Lehane grade of glottic visualization was registered. If the grade of glottis view according to Cormack-Lehane classification was less than 2b the patient was intubated using the curved blade laryngoscope. If the grade of glottic view was equal or more than 2b the tracheal intubation was carried further with the rigid tube.

Sponsors and collaborators

Lead sponsor

Iuliu Hatieganu University of Medicine and Pharmacy

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Nov 14, 2017
Registry last updated
Apr 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.