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.

NCT06149338 | Completed Results DMC

• 1 other identifier: 141/09.07.2023
• Study Type: interventional
• Target: 264
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Vie Scope; Macintosh; Rate of successful intubation; Intubation time

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Rate of Successful Intubation

  Evaluation immediately after the intubation attempts

• Visualization of the Glottis, According to Cormack Lehane Classification

  This outcome will be evaluated during laryngoscopy and intubation of each patient

Study Arms (2)

Patients being intubated using Macintosh laryngoscope

EXPERIMENTAL

Device: Macintosh laryngoscope

Patients being intubated using Vie Scope laryngoscope

EXPERIMENTAL

Device: Vie Scope

Interventions

Macintosh laryngoscope DEVICE

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.

Patients being intubated using Macintosh laryngoscope

Vie Scope DEVICE

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.

Patients being intubated using Vie Scope laryngoscope

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Saint Andrew's General Hospital of Patras

Pátrai, 263 32, Greece

Location

Limitations and Caveats

The airway operator was an anesthesiologist trainee with minimum experience. Thereby, the outcomes are not indicative of the Macintosh and Vie Scope use by consultants. Moreover, patients in both groups were not reassessed after endotracheal intubation, by direct laryngoscopy, in order to detect any potential complications. Finally, the current study was focused on the easy airway management of adults, providing no data about difficult airway management in adults and pediatric patients.

Results Point of Contact

• Title: Dr. Vasileios Boviatsis
• Organization: Saint Andrew's General Hospital of Patras

billboviatsis@gmail.com

+306982925945

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 20, 2023
• First Posted: November 29, 2023
• Study Start: January 26, 2024
• Primary Completion: August 21, 2024
• Study Completion: August 21, 2024
• Last Updated: February 7, 2025
• Results First Posted: December 6, 2024

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)