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: Hence, a Randomized Controlled Prospective Single-blind Clinical Trial Will be Conducted

Sponsor

St. Andrew's General Hospital, Patras, Greece (Other)

Overall Status

Recruiting

CT.gov ID

NCT06149338

Collaborator

(none)

240

Enrollment

Location

Arms

12.5

Anticipated Duration (Months)

19.2

Patients Per Site Per Month

Study Details

Study Description

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. Hence, a randomized controlled prospective single-blind 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.

Condition or Disease	Intervention/Treatment	Phase
Laryngoscopy	Device: Macintosh laryngoscope Device: Vie Scope	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

240 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

VIE SCOPE: An Alternative Method of Laryngoscopy and Airway Management

Actual Study Start Date :

Nov 16, 2022

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Rate of successful intubation [This outcome depends on whether the intubation of each patient will be successful or not, during]
Required mean intubation time [From insertion of the laryngoscope into the patient's mouth to the inflation of tube's cuff on each patient]

Secondary Outcome Measures

rate of successful intubation with the first attempt [This outcome depends on whether the intubation of each patient will be successful or not, during]
Visualization of glottis, according to Cormack Lehane classification [This outcome will be evaluated during intubation of each patient]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Saint Andrew's General Hospital of Patras	Patra		Greece	263 32

Sponsors and Collaborators

St. Andrew's General Hospital, Patras, Greece

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Vasileios Boviatsis, Medical Doctor, St. Andrew's General Hospital, Patras, Greece

ClinicalTrials.gov Identifier:

NCT06149338

Other Study ID Numbers:

141/09.07.2023

First Posted:

Nov 29, 2023

Last Update Posted:

Nov 29, 2023

Last Verified:

Nov 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Vasileios Boviatsis, Medical Doctor, St. Andrew's General Hospital, Patras, Greece

Vie Scope, Macintosh, rate of successful intubation, intubation time

Study Results

No Results Posted as of Nov 29, 2023