NCT06149338

The Rate of Successful Intubation and the Required Time for Intubation, Using Vie Scope and Macintosh Laryngoscope Will be Compared, in Order to Evaluate the Efficacy of Vie Scope in Comparison With Macintosh in Expected Easy Airways.

Completed NA Results posted Last updated 7 February 2025

What this trial tests

NA trial testing Macintosh laryngoscope in Laryngoscopy in 264 participants. Completed in 21 August 2024.

Timeline

26 January 2024

Primary endpoint
21 August 2024

21 August 2024

Quick facts

Lead sponsor	St. Andrew's General Hospital, Patras, Greece
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	264
Start date	26 January 2024
Primary completion	21 August 2024
Estimated completion	21 August 2024
Sites	1 location across Greece

Drugs / interventions tested

• Macintosh laryngoscope
• Vie Scope

Conditions studied

• Laryngoscopy — all drugs for Laryngoscopy →

Sponsor

St. Andrew's General Hospital, Patras, Greece

Who can join

18 and older, any sex, with Laryngoscopy. 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.

Rate of Successful Intubation With One Attempt Primary · Evaluation immediately after the first attempt of intubation

This outcome depends on whether the intubation of each patient will be successful or not, after the first attempt of intubation

Group	Value	95% CI
Patients Being Intubated Using Macintosh Laryngoscope	132
Patients Being Intubated Using Vie Scope Laryngoscope	119

Mean Intubation Time Primary · Assessment of the required mean time interval for intubation, immediately after the insertion of laryngoscope's blade into the patient's mouth

Mean time interval required for intubation, which is determined from the time of the insertion of the laryngoscope into the patient's mouth until the time of the inflation of the tube's cuff on each patient

Group	Value	95% CI
Patients Being Intubated Using Macintosh Laryngoscope	8.08	± 5.34
Patients Being Intubated Using Vie Scope Laryngoscope	16.65	± 5.02

Rate of Successful Intubation Secondary · Evaluation immediately after the intubation attempts

This outcome depends on whether the intubation of each patient will be successful or not

Group	Value	95% CI
Patients Being Intubated Using Macintosh Laryngoscope	132
Patients Being Intubated Using Vie Scope Laryngoscope	124

Visualization of the Glottis, According to Cormack Lehane Classification Secondary · This outcome will be evaluated during laryngoscopy and intubation of each patient

Ability to visualize the glottis, according to Cormack Lehane classification. The specific classification is divided into four grades (1-4). The higher the grade, the higher the likelihood of difficult intubation.

Group	Value	95% CI
Patients Being Intubated Using Macintosh Laryngoscope	100
Patients Being Intubated Using Vie Scope Laryngoscope	102
Patients Being Intubated Using Macintosh Laryngoscope	20
Patients Being Intubated Using Vie Scope Laryngoscope	21
Patients Being Intubated Using Macintosh Laryngoscope	12
Patients Being Intubated Using Vie Scope Laryngoscope	9

Sponsor's own description

The rate of successful intubation and the required time for intubation, using Vie Scope and Macintosh Laryngoscope will be compared, in order to evaluate the efficacy of Vie Scope in comparison with Macintosh in expected easy airways. Hence, a prospective randomized controlled single-blind superiority clinical trial will be conducted.

Inclusion criteria: patients of both sexes, positive or negative rapid test for COVID-19 or possible contamination, age ≥18 years old, BMI: 18.5 - 30 kg/m2, visualization of the glottis grade 1 or 2, according to Cormack-Lehane Classification.

Exclusion criteria: age under 18 years old, BMI under 18.5 kg/m2 and BMI over 30 kg/m2, visualization of the glottis grade 3 - 4, according to Cormack-Lehane Classification.

The laryngoscopy and intubation of the patients will be attempted by the same person-resident of Anesthesiology, under the supervision of experienced Anesthesiologist consultants.

Publications & conference data

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

1. Comparison of Vie Scope and Macintosh Laryngoscope in Adults With an Expected Easy Airway: A Randomized Controlled Trial.
   Boviatsis VI, Triantopoulos A, Pouliakis A, Boviatsi D, et al · · 2025 · PMID 40861572 · DOI 10.7759/cureus.88566