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.

Vie Scope Versus Macintosh Laryngoscope in Expected Easy Airways: A Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Laryngoscopy
• Intervention / Treatment: Device: Macintosh laryngoscope; Device: Vie Scope

• Study Type: Interventional
• Enrollment (Actual): 264
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Greece
  • Patra, Greece, 263 32
    • Saint Andrew's General Hospital of Patras

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients being intubated using Macintosh laryngoscope	Device: Macintosh laryngoscope; Macintosh laryngoscope has been the gold standard for endotracheal intubation since the middle of 20th century. During laryngoscopy and direct vision of the vocal cords, an endotracheal tube is passed into the trachea, establishing the airway.
Experimental: Patients being intubated using Vie Scope laryngoscope	Device: Vie Scope; Vie Scope is a laryngoscope, whose function is relied on Seldinger technique. Firstly, bougie is passed through the translucent barrel of Vie Scope under direct vision between the vocal cords and into the trachea. Then, Vie Scope is removed and an endotracheal tube is passed over the bougie, which will be finally removed. The inflation of the endotracheal tube's cuff is followed by ventilation and confirmation of the tube placement.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Successful Intubation With One Attempt	This outcome depends on whether the intubation of each patient will be successful or not, after the first attempt of intubation	Evaluation immediately after the first attempt of intubation
Mean Intubation Time	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	Assessment of the required mean time interval for intubation, immediately after the insertion of laryngoscope's blade into the patient's mouth

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Successful Intubation	This outcome depends on whether the intubation of each patient will be successful or not	Evaluation immediately after the intubation attempts
Visualization of the Glottis, According to Cormack Lehane Classification	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.	This outcome will be evaluated during laryngoscopy and intubation of each patient

Collaborators and Investigators

• Sponsor: St. Andrew's General Hospital, Patras, Greece

Study record dates

Study Major Dates

• Study Start (Actual): January 26, 2024
• Primary Completion (Actual): August 21, 2024
• Study Completion (Actual): August 21, 2024

Study Registration Dates

• First Submitted: November 20, 2023
• First Submitted That Met QC Criteria: November 27, 2023
• First Posted (Actual): November 29, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 24, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Vie Scope; Intubation time; Macintosh; Rate of successful intubation
• Other Study ID Numbers: 141/09.07.2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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