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.

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 264 (actual)
• Sponsor: St. Andrew's General Hospital, Patras, Greece · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Laryngoscopy

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2024-01-26
• Primary completion: 2024-08-21
• Completion: 2024-08-21
• First posted: 2023-11-29
• Last updated: 2025-02-07
• Results posted: 2024-12-06

Locations

1 site across 1 country: Greece