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

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

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.

Study Overview

• Status: Completed
• Conditions: Intubation;Difficult
• Intervention / Treatment: Device: classical laryngoscopy; Device: rigid tube for laryngoscopy

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 Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Romania
  • Cluj
    • Cluj Napoca, Cluj, Romania, 400006
      • Cluj County Emergency Hospital- ENT Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: laryngoscopy and tracheal intubation; 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.

Device: classical laryngoscopy; 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; Device: rigid tube for laryngoscopy; the view of glottis achieved with the rigid tub for laryngoscopy and tracheal intubation with an elastic gum bougie performed

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Tracheal Intubation With the Rigid Tube	the time from starting to use the rigid tube for laryngoscopy until the airway was secured.	120 seconds

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	60 seconds

Collaborators and Investigators

• Sponsor: Iuliu Hatieganu University of Medicine and Pharmacy
• Investigators: Principal Investigator: Ioan Florin Marchis, Md, University of Medicine and Pharmacy Iuliu Hatieganu- Cluj Napoca, Romania

Publications and helpful links

General Publications

• Norskov AK, Rosenstock CV, Wetterslev J, Lundstrom LH. Incidence of unanticipated difficult airway using an objective airway score versus a standard clinical airway assessment: the DIFFICAIR trial - trial protocol for a cluster randomized clinical trial. Trials. 2013 Oct 23;14:347. doi: 10.1186/1745-6215-14-347.
• Rutter JM, Murphy PG. Cormack and Lehane revisited. Anaesthesia. 1997 Sep;52(9):927. No abstract available.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2017
• Primary Completion (Actual): December 1, 2019
• Study Completion (Actual): December 7, 2019

Study Registration Dates

• First Submitted: November 3, 2017
• First Submitted That Met QC Criteria: November 12, 2017
• First Posted (Actual): November 14, 2017

Study Record Updates

• Last Update Posted (Actual): April 9, 2021
• Last Update Submitted That Met QC Criteria: March 16, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: laryngoscopy; retromolar
• Other Study ID Numbers: MIFlorin

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No