NCT03341507

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

Completed NA Results posted Last updated 9 April 2021

What this trial tests

NA trial testing classical laryngoscopy in Intubation;Difficult in 64 participants. Completed in 7 December 2019.

Timeline

1 February 2017

Primary endpoint
1 December 2019

7 December 2019

Quick facts

Lead sponsor	Iuliu Hatieganu University of Medicine and Pharmacy
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	64
Start date	1 February 2017
Primary completion	1 December 2019
Estimated completion	7 December 2019
Sites	1 location across Romania

Drugs / interventions tested

• classical laryngoscopy
• rigid tube for laryngoscopy

Conditions studied

• Intubation;Difficult — all drugs for Intubation;Difficult →

Sponsor

Iuliu Hatieganu University of Medicine and Pharmacy

Who can join

Adults 18 to 75, any sex, with Intubation;Difficult. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Time to Tracheal Intubation With the Rigid Tube Primary · 120 seconds

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

Group	Value	95% CI
Laryngoscopy and Tracheal Intubation	50.5	38 – 67

Complications During Intubation With Rigid Tube Secondary · 5 minutes

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

Group	Value	95% CI
Laryngoscopy and Tracheal Intubation	1

Late Complications of Intubation With Rigid Tube Secondary · 3 days

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

Group	Value	95% CI
Laryngoscopy and Tracheal Intubation	8

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. Secondary · 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.

Group	Value	95% CI
Laryngoscopy and Tracheal Intubation	34

Adverse events — posted to ClinicalTrials.gov

Time frame: complications noticed during and following the use of rigid tube : time frame-3 days. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Laryngoscopy and Tracheal Intubation

Serious: 1/64 (2%)

Deaths: 0/64

Serious adverse events (1 terms)

Reaction	System	Laryngoscopy and Tracheal …
hypoxia	Respiratory, thoracic and mediastinal disorders	—

Other adverse events (2 terms — click to expand)

Reaction	System	Laryngoscopy and Tracheal …
sore throat	Respiratory, thoracic and mediastinal disorders	—
upper lip injury	Skin and subcutaneous tissue disorders	—

Most-reported serious reactions: hypoxia.

Data from ClinicalTrials.gov NCT03341507 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Tracheal intubation with the rigid tube for laryngoscopy - a new method.
   Marchis IF, Radeanu D, Cosgarea M. · · 2019 · cited 2× · PMID 30880996 · DOI 10.2147/tcrm.s190186