LaryngoscopyNCT06149338

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.

A study testing Macintosh laryngoscope and Vie Scope in people with Laryngoscopy, run by St. Andrew's General Hospital, Patras, Greece at 1 site in Greece.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Laryngoscopy
What is being tested?: Macintosh laryngoscope and Vie Scope
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 264 participants
Where: 1 siteGreece
Study dates: 26 Jan 2024to 21 Aug 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Greece1 site

Saint Andrew's General Hospital of Patras
Pátrai, 263 32

Other trials in Greece

About this study

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

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
Being tested: Macintosh laryngoscope, Vie Scope
Keywords: Vie Scope, Macintosh, Rate of successful intubation, Intubation time

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Macintosh laryngoscopeDevice
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.
Vie ScopeDevice
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.

Study groups in NCT06149338
Study group	Role	What they receive
Patients being intubated using Macintosh laryngoscope	Experimental	Not described Receives: Device: Macintosh laryngoscope
Patients being intubated using Vie Scope laryngoscope	Experimental	Not described Receives: Device: Vie Scope

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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
Measured: 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
This outcome depends on whether the intubation of each patient will be successful or not
Measured: 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.
Measured: This outcome will be evaluated during laryngoscopy and intubation of each patient

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Jan 202421 Aug 2024

First posted29 Nov 2023
Study start26 Jan 2024
Primary completion21 Aug 2024
Study completion21 Aug 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for LaryngoscopyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 264 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06149338
Sponsor's protocol ID: 141/09.07.2023
Status last verified: Jan 2025
First submitted: 20 Nov 2023
Last updated: 7 Feb 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Laryngoscopy trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Vie Scope Versus Macintosh Laryngoscope in Expected Easy Airways: A Randomized Controlled Trial
ClinicalTrials.gov ID: NCT06149338
Acronym / sponsor ID: 141/09.07.2023
Conditions: Laryngoscopy
Keywords: Vie Scope, Macintosh, Rate of successful intubation, Intubation time
Study type: Interventional
Recruitment status: Completed
Enrolment: 264 participants (actual)
Lead sponsor: St. Andrew's General Hospital, Patras, GreeceUniversity, hospital or other
Study start: 26 Jan 2024 (actual)
Primary completion: 21 Aug 2024 (actual)
Study completion: 21 Aug 2024 (actual)
First posted: 29 Nov 2023 (actual)
Results: Posted 6 Dec 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Patients being intubated using Macintosh laryngoscope	Experimental	Device: Macintosh laryngoscope
Patients being intubated using Vie Scope laryngoscope	Experimental	Device: Vie Scope

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (3 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Macintosh laryngoscopeMacintosh 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	Patients being intubated using Macintosh laryngoscope
Vie ScopeVie 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.	Device	Patients being intubated using Vie Scope laryngoscope

Primary outcome

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

2 secondary outcomes

Rate of Successful Intubation
Time frame: Evaluation immediately after the intubation attempts
Visualization of the Glottis, According to Cormack Lehane Classification
Time frame: This outcome will be evaluated during laryngoscopy and intubation of each patient

Results and safety

Results posted to the registry on 6 Dec 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Patients Being Intubated Using Macintosh Laryngoscope	132	132
Patients Being Intubated Using Vie Scope Laryngoscope	132	132

Primary outcome: Rate of Successful Intubation With One Attempt

Time frame: Evaluation immediately after the first attempt of intubation. Count of participants. Unit: Participants

Measure	Patients Being Intubated Using Macintosh Laryngoscope n = 132	Patients Being Intubated Using Vie Scope Laryngoscope n = 132
Value	132	119

Patients Being Intubated Using Macintosh Laryngoscope vs Patients Being Intubated Using Vie Scope Laryngoscope: p = 0.0002, Chi-squared
Patients Being Intubated Using Macintosh Laryngoscope vs Patients Being Intubated Using Vie Scope Laryngoscope: p <0.05, Fisher Exact

Primary outcome: Mean Intubation Time

Time frame: Assessment of the required mean time interval for intubation, immediately after the insertion of laryngoscope's blade into the patient's mouth. Mean (Standard Deviation). Unit: seconds

Measure	Patients Being Intubated Using Macintosh Laryngoscope n = 132	Patients Being Intubated Using Vie Scope Laryngoscope n = 132
Value	8.08 (5.34)	16.65 (5.02)

Patients Being Intubated Using Macintosh Laryngoscope vs Patients Being Intubated Using Vie Scope Laryngoscope: p < 0.0001, Kruskal-Wallis

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: During the intubation process (< 60 sec), the patient was simultaneously assessed for complications like injury of the structures of the upper airway, caused by the manipulations of the airway operator for the airway establishment. After the successful endotracheal intubation, the patients were not reassessed for any complications.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Patients Being Intubated Using Macintosh Laryngoscope	0 of 132 (0%)	0 of 132 (0%)	0 of 132
Patients Being Intubated Using Vie Scope Laryngoscope	0 of 132 (0%)	0 of 132 (0%)	0 of 132

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Laryngoscopy

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Recruiting
Hyperangulated vs Standard Videolaryngoscopy vs Direct Laryngoscopy for Double-Lumen Endobronchial Tube Intubation
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Not yet recruitingObservational study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Macintosh laryngoscope and Vie Scope in people with Laryngoscopy, run by St. Andrew's General Hospital, Patras, Greece at 1 site in Greece.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of Successful Intubation With One Attempt (time frame: Evaluation immediately after the first attempt of intubation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06149338.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2025.