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.

NCT ID: NCT06149338

Last Updated: 2025-02-07

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

264 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-26

Study Completion Date

2024-08-21

Brief Summary

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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.

Detailed Description

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Conditions

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Laryngoscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Patients being intubated using Macintosh laryngoscope

Group Type EXPERIMENTAL

Macintosh laryngoscope

Intervention Type 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 Vie Scope laryngoscope

Group Type EXPERIMENTAL

Vie Scope

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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St. Andrew's General Hospital, Patras, Greece

OTHER

Sponsor Role lead

Responsible Party

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Vasileios Boviatsis

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Saint Andrew's General Hospital of Patras

Pátrai, , Greece

Site Status

Countries

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Greece

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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141/09.07.2023

Identifier Type: -

Identifier Source: org_study_id

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