Intubation; Difficult or FailedUED-VLGNCT05721690
UED-A Videolaryngoscope vs. Glidescope Titanium for Elective Tracheal Intubation
A study testing UED-A Videolaryngoscopy and Glidescope Videolaryngoscopy in people with Intubation; Difficult or Failed, run by Campus Bio-Medico University at 1 site in Italy.
Trial summary
The present randomized clinical trial wants to compare the efficacy and safety of UED-A videolaryngoscope to Glidescope Titanium for routinely tracheal intubation in 60 adults, in terms of successful rate, no. attempts and manoeuvre duration. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intubation; Difficult or Failed
- What is being tested?
- UED-A Videolaryngoscopy and Glidescope Videolaryngoscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 1 Feb 2023to 13 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients candidates for general anesthesia in elective general surgery
- Age over 18 years
- American Society of Anesthesiologists (ASA) physical status I-III.
Who cannot join
- Refusal to sign informed consent
- Paediatric population
- ASA physical status IV
- Emergency tracheal intubation
- Independent Predictors of difficult Videolaryngoscopy (Neck extension < 80°, macroglossia, interincisor distance < 3 cm, anatomical alterations of the neck, cardiac surgery, ear-nose-throat surgery)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: UED-A Videolaryngoscope vs. Glidescope Titanium for Elective Tracheal Intubation: a Randomized Clinical Trial
The present randomized clinical trial wants to compare the efficacy and safety of UED-A videolaryngoscope to Glidescope Titanium for routinely tracheal intubation in 60 adults, in terms of successful rate, no. attempts and manoeuvre duration.
- Conditions
- Intubation; Difficult or Failed
- Being tested
- UED-A Videolaryngoscopy, Glidescope Videolaryngoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UED-A VideolaryngoscopyDevice
Tracheal Intubation with UED-A videolaryngoscope
Glidescope VideolaryngoscopyDevice
Tracheal Intubation with Glidescope Titanium videolaryngoscope
| Study group | Role | What they receive |
|---|---|---|
| UED-A | Experimental | Tracheal Intubation with UED-A videolaryngoscope Receives: Device: UED-A Videolaryngoscopy |
| GLIDESCOPE | Active comparator | Tracheal Intubation with Glidescope Titanium videolaryngoscope Receives: Device: Glidescope Videolaryngoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tracheal intubation rate
Successful tracheal intubation rate
Measured: 30 minutes
Number of attempts
Number of attempts for a successful tracheal intubation
Measured: 30 minutes
Total time of intubation
Time needed to perform a tracheal intubation from the insertion of the video laryngoscope into the patient mouth
Measured: 15 minutes
Time to glottis visualization
Time needed to visualize the glottis from the insertion of the video laryngoscope into the patient mouth
Measured: 15 minutes
Cormack-Lehane grade
Cormack-Lehane grade observed at videolaryngoscopy Grade 1: Full view of glottis Grade 2: Partial view of glottis Grade 3: Only epiglottis seen, none of glottis seen Grade 4: Neither glottis nor epiglottis seen
Measured: 15 minutes
Secondary outcomes (4)
Rate of External laryngeal pressure
Rate of external laryngeal pressure during laryngoscopy
Measured: 15 minutes
Rate of of post-laryngoscopy side effects
Rate of of post-laryngoscopy side effects (bleeding, postoperative sore throat and/or dysphonia)
Measured: 24 hours
Rate of Desaturation
Rate of Desaturation (spO2 < 93%) during tracheal intubation attempts
Measured: 15 minutes
Satisfaction Scale
Clinicians Satisfaction with the use of the videolaryngoscope, expressed by a 0-10 numeric rating scale (0 = the worst videolaryngoscopy ever performed; 10 = the best videolaryngoscopy ever performed)
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2023
- Study start1 Feb 2023
- Primary completion12 May 2023
- Study completion13 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Intubation; Difficult or FailedStudies 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
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Campus Bio-Medico University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giuseppe Pascarella, Campus Bio-Medico University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05721690
- Sponsor's protocol ID
- PAR 72.22
- Acronym
- UED-VLG
- Status last verified
- Aug 2023
- First submitted
- 1 Feb 2023
- Last updated
- 30 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Agro FE, Doyle DJ, Vennari M. Use of GlideScope(R) in adults: an overview. Minerva Anestesiol. 2015 Mar;81(3):342-51. Epub 2014 May 27.
PubMed 24861718Law JA, Duggan LV, Asselin M, Baker P, Crosby E, Downey A, Hung OR, Kovacs G, Lemay F, Noppens R, Parotto M, Preston R, Sowers N, Sparrow K, Turkstra TP, Wong DT, Jones PM; Canadian Airway Focus Group. Canadian Airway Focus Group updated consensus-based recommendations for management of the difficult airway: part 2. Planning and implementing safe management of the patient with an anticipated difficult airway. Can J Anaesth. 2021 Sep;68(9):1405-1436. doi: 10.1007/s12630-021-02008-z. Epub 2021 Jun 8.
PubMed 34105065Aziz MF, Healy D, Kheterpal S, Fu RF, Dillman D, Brambrink AM. Routine clinical practice effectiveness of the Glidescope in difficult airway management: an analysis of 2,004 Glidescope intubations, complications, and failures from two institutions. Anesthesiology. 2011 Jan;114(1):34-41. doi: 10.1097/ALN.0b013e3182023eb7.
PubMed 21150569Aziz MF, Bayman EO, Van Tienderen MM, Todd MM; StAGE Investigator Group; Brambrink AM. Predictors of difficult videolaryngoscopy with GlideScope(R) or C-MAC(R) with D-blade: secondary analysis from a large comparative videolaryngoscopy trial. Br J Anaesth. 2016 Jul;117(1):118-23. doi: 10.1093/bja/aew128.
PubMed 27317711Al-Ghamdi AA, El Tahan MR, Khidr AM. Comparison of the Macintosh, GlideScope(R), Airtraq(R), and King Vision laryngoscopes in routine airway management. Minerva Anestesiol. 2016 Dec;82(12):1278-1287. Epub 2016 Apr 22.
PubMed 27103030Brozek T, Bruthans J, Porizka M, Blaha J, Ulrichova J, Michalek P. A Randomized Comparison of Non-Channeled GlidescopeTM Titanium Versus Channeled KingVisionTM Videolaryngoscope for Orotracheal Intubation in Obese Patients with BMI > 35 kg.m-2. Diagnostics (Basel). 2020 Nov 29;10(12):1024. doi: 10.3390/diagnostics10121024.
PubMed 33260374Turkstra TP, Turkstra DC, Pavlosky AW, Jones PM. Simultaneous en bloc endotracheal tube insertion with GlideScope(R) Titanium video laryngoscope use: a randomized-controlled trial. Can J Anaesth. 2020 Nov;67(11):1515-1523. doi: 10.1007/s12630-020-01778-2. Epub 2020 Aug 19.
PubMed 32815101Migliorelli S, Strumia A, Costa F, Puricelli G, Ruggiero A, Schiavoni L, Mattei A, Carassiti M, Cataldo R, Agro FE, Pascarella G. Hyper-angulated (Glidescope) versus intermediate-angled (UED-A) videolaryngoscopy for routine tracheal intubation in adults: a prospective randomized controlled trial. Sci Rep. 2026 Jan 14;16(1):1986. doi: 10.1038/s41598-025-30932-3.
PubMed 41535320
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- UED-A Videolaryngoscope vs. Glidescope Titanium for Elective Tracheal Intubation: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05721690
- Acronym / sponsor ID
- UED-VLG / PAR 72.22
- Conditions
- Intubation; Difficult or Failed
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Campus Bio-Medico UniversityUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 12 May 2023 (actual)
- Study completion
- 13 May 2023 (actual)
- First posted
- 10 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The present randomized clinical trial wants to compare the efficacy and safety of UED-A videolaryngoscope to Glidescope Titanium for routinely tracheal intubation in 60 adults, in terms of successful rate, no. attempts and manoeuvre duration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| UED-A | Experimental | Device: UED-A VideolaryngoscopyTracheal Intubation with UED-A videolaryngoscope |
| GLIDESCOPE | Active comparator | Device: Glidescope VideolaryngoscopyTracheal Intubation with Glidescope Titanium videolaryngoscope |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients candidates for general anesthesia in elective general surgery
- Age over 18 years
- American Society of Anesthesiologists (ASA) physical status I-III.
Key exclusion criteria (5 listed)
- Refusal to sign informed consent
- Paediatric population
- ASA physical status IV
- Emergency tracheal intubation
- Independent Predictors of difficult Videolaryngoscopy (Neck extension < 80°, macroglossia, interincisor distance < 3 cm, anatomical alterations of the neck, cardiac surgery, ear-nose-throat surgery)
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 |
|---|---|---|
| UED-A VideolaryngoscopyTracheal Intubation with UED-A videolaryngoscope | Device | UED-A |
| Glidescope VideolaryngoscopyTracheal Intubation with Glidescope Titanium videolaryngoscope | Device | GLIDESCOPE |
Primary outcome
Tracheal intubation rate
Time frame: 30 minutes
Successful tracheal intubation rate
Number of attempts
Time frame: 30 minutes
Number of attempts for a successful tracheal intubation
Total time of intubation
Time frame: 15 minutes
Time needed to perform a tracheal intubation from the insertion of the video laryngoscope into the patient mouth
Time to glottis visualization
Time frame: 15 minutes
Time needed to visualize the glottis from the insertion of the video laryngoscope into the patient mouth
Cormack-Lehane grade
Time frame: 15 minutes
Cormack-Lehane grade observed at videolaryngoscopy Grade 1: Full view of glottis Grade 2: Partial view of glottis Grade 3: Only epiglottis seen, none of glottis seen Grade 4: Neither glottis nor epiglottis seen
4 secondary outcomes
Rate of External laryngeal pressure
Time frame: 15 minutes
Rate of of post-laryngoscopy side effects
Time frame: 24 hours
Rate of Desaturation
Time frame: 15 minutes
Satisfaction Scale
Time frame: 30 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2023.
- Background: PubMed 24861718Agro FE, Doyle DJ, Vennari M. Use of GlideScope(R) in adults: an overview. Minerva Anestesiol. 2015 Mar;81(3):342-51. Epub 2014 May 27.
- Background: PubMed 34105065Law JA, Duggan LV, Asselin M, Baker P, Crosby E, Downey A, Hung OR, Kovacs G, Lemay F, Noppens R, Parotto M, Preston R, Sowers N, Sparrow K, Turkstra TP, Wong DT, Jones PM; Canadian Airway Focus Group. Canadian Airway Focus Group updated consensus-based recommendations for management of the difficult airway: part 2. Planning and implementing safe management of the patient with an anticipated difficult airway. Can J Anaesth. 2021 Sep;68(9):1405-1436. doi: 10.1007/s12630-021-02008-z. Epub 2021 Jun 8.
- Background: PubMed 21150569Aziz MF, Healy D, Kheterpal S, Fu RF, Dillman D, Brambrink AM. Routine clinical practice effectiveness of the Glidescope in difficult airway management: an analysis of 2,004 Glidescope intubations, complications, and failures from two institutions. Anesthesiology. 2011 Jan;114(1):34-41. doi: 10.1097/ALN.0b013e3182023eb7.
- Background: PubMed 27317711Aziz MF, Bayman EO, Van Tienderen MM, Todd MM; StAGE Investigator Group; Brambrink AM. Predictors of difficult videolaryngoscopy with GlideScope(R) or C-MAC(R) with D-blade: secondary analysis from a large comparative videolaryngoscopy trial. Br J Anaesth. 2016 Jul;117(1):118-23. doi: 10.1093/bja/aew128.
- Background: PubMed 27103030Al-Ghamdi AA, El Tahan MR, Khidr AM. Comparison of the Macintosh, GlideScope(R), Airtraq(R), and King Vision laryngoscopes in routine airway management. Minerva Anestesiol. 2016 Dec;82(12):1278-1287. Epub 2016 Apr 22.
- Background: PubMed 33260374Brozek T, Bruthans J, Porizka M, Blaha J, Ulrichova J, Michalek P. A Randomized Comparison of Non-Channeled GlidescopeTM Titanium Versus Channeled KingVisionTM Videolaryngoscope for Orotracheal Intubation in Obese Patients with BMI > 35 kg.m-2. Diagnostics (Basel). 2020 Nov 29;10(12):1024. doi: 10.3390/diagnostics10121024.
- Background: PubMed 32815101Turkstra TP, Turkstra DC, Pavlosky AW, Jones PM. Simultaneous en bloc endotracheal tube insertion with GlideScope(R) Titanium video laryngoscope use: a randomized-controlled trial. Can J Anaesth. 2020 Nov;67(11):1515-1523. doi: 10.1007/s12630-020-01778-2. Epub 2020 Aug 19.
- Derived from this study: PubMed 41535320Migliorelli S, Strumia A, Costa F, Puricelli G, Ruggiero A, Schiavoni L, Mattei A, Carassiti M, Cataldo R, Agro FE, Pascarella G. Hyper-angulated (Glidescope) versus intermediate-angled (UED-A) videolaryngoscopy for routine tracheal intubation in adults: a prospective randomized controlled trial. Sci Rep. 2026 Jan 14;16(1):1986. doi: 10.1038/s41598-025-30932-3.
- Individual participant dataSharing planned: No
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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 UED-A Videolaryngoscopy and Glidescope Videolaryngoscopy in people with Intubation; Difficult or Failed, run by Campus Bio-Medico University at 1 site in Italy.
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 3 inclusion and 5 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 30 Aug 2023. 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 Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Tracheal intubation rate (time frame: 30 minutes). The study lists 5 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 NCT05721690, which also lists 8 linked publications.
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 30 Aug 2023.