Intubating Laryngeal AirwayVL or DLNCT07004621
Videolaryngoscopy Versus Direct Laryngoscopy for Endotracheal Intubation of Obese Patients: a Prospective Randomized Trial
A study testing measurment of intubation time in seconds in people with Intubating Laryngeal Airway, run by Jagiellonian University at 1 site in Poland.
Trial summary
Patients were randomly assigned (1:1) to either a Macintosh laryngoscope group ("Macintosh group") or a videolaryngoscope group ("Video group"). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intubating Laryngeal Airway
- What is being tested?
- measurment of intubation time in seconds
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 268 participants
- Where
- 1 sitePoland
- Study dates
- 1 Mar 2024to 31 Dec 2024
- 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
- Inclusion criteria: Adult patients (> 18 years) of both sexes with BMI > 35 kg/m² scheduled for laparoscopic sleeve gastrectomy (ASA < IV).
- Exclusion criteria:
- Patient's refusal to participate.
- Known allergy to drugs used during anaesthesia.
- Chronic pain syndromes.
- Chronic opioid use.
Trial locations and contacts
1 site in 1 country.
Poland1 site
SP ZOZ Szpital Uniwersytecki w Krakowie
Krakow, Lesser Poland Voivodeship, 30-688
About this study
Patients were randomly assigned (1:1) to either a Macintosh laryngoscope group ("Macintosh group") or a videolaryngoscope group ("Video group").
Read the detailed description
In the Macintosh group, intubation was performed with a standard curved Macintosh blade. In the Video group, intubation was performed with the assigned videolaryngoscope. If intubation proved difficult with the initially assigned device, anaesthesiologists could switch to the alternative method at their discretion (rescue technique).
- Conditions
- Intubating Laryngeal Airway
- Being tested
- measurment of intubation time in seconds
- Keywords
- laryngoscopy, tracheal intubation, o besity patients ,, v ideolaryngoscopes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
measurment of intubation time in secondsOther
determine whether modern technologies such as videolaryngoscopy shorten intubation time.
| Study group | Role | What they receive |
|---|---|---|
| Conventional | Active comparator | traditional laryngoscope for the first laryngoscopy Receives: Other: measurment of intubation time in seconds |
| Video-Laryngoscope | Experimental | video laryngoscope will be used to intubate half of the people Receives: Other: measurment of intubation time in seconds |
What is being measured
The primary outcome is the main question the study is designed to answer.
determine whether modern technologies such as videolaryngoscopy shorten intubation time.
measurment of intubation time in seconds
Measured: 1 day
Secondary outcomes (1)
complications
included the incidence of failed intubation with the assigned device, the number of intubation attempts, and the use of an introducer (bougie). Any intubation attempt that failed could be rescued with the alternative device.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2025
- Study start1 Mar 2024
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intubating Laryngeal AirwayStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study group will be male and female patients, ASA II or III, over 18 years of age and under 75 years of age. Each patient will undergo abdominal (bariatric) surgery.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 268 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jagiellonian University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tomasz Skladzien, Jagiellonian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07004621
- Sponsor's protocol ID
- 1072.6120.135.2023 (Cracow)
- Acronym
- VL or DL
- Status last verified
- May 2025
- First submitted
- 26 May 2025
- Last updated
- 4 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Participatned did not agree
Publications
Yumul R, Elvir-Lazo OL, White PF, Sloninsky A, Kaplan M, Kariger R, Naruse R, Parker N, Pham C, Zhang X, Wender RH. Comparison of three video laryngoscopy devices to direct laryngoscopy for intubating obese patients: a randomized controlled trial. J Clin Anesth. 2016 Jun;31:71-7. doi: 10.1016/j.jclinane.2015.12.042. Epub 2016 Mar 23.
PubMed 27185681
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Videolaryngoscopy Versus Direct Laryngoscopy for Endotracheal Intubation of Obese Patients: a Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT07004621
- Acronym / sponsor ID
- VL or DL / 1072.6120.135.2023 (Cracow)
- Conditions
- Intubating Laryngeal Airway
- Keywords
- laryngoscopy, tracheal intubation, o besity patients ,, v ideolaryngoscopes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 268 participants (actual)
- Lead sponsor
- Jagiellonian UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 4 Jun 2025 (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.
Patients were randomly assigned (1:1) to either a Macintosh laryngoscope group ("Macintosh group") or a videolaryngoscope group ("Video group").
Detailed description
In the Macintosh group, intubation was performed with a standard curved Macintosh blade. In the Video group, intubation was performed with the assigned videolaryngoscope. If intubation proved difficult with the initially assigned device, anaesthesiologists could switch to the alternative method at their discretion (rescue technique).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- The study group will be male and female patients, ASA II or III, over 18 years of age and under 75 years of age. Each patient will undergo abdominal (bariatric) surgery.
| Arm | Type | Receives |
|---|---|---|
| Conventional | Active comparator | Other: measurment of intubation time in secondstraditional laryngoscope for the first laryngoscopy |
| Video-Laryngoscope | Experimental | Other: measurment of intubation time in secondsvideo laryngoscope will be used to intubate half of the people |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| measurment of intubation time in secondsdetermine whether modern technologies such as videolaryngoscopy shorten intubation time. | Other | Conventional, Video-Laryngoscope |
Primary outcome
determine whether modern technologies such as videolaryngoscopy shorten intubation time.
Time frame: 1 day
measurment of intubation time in seconds
1 secondary outcome
complications
Time frame: 1 day
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 4 Jun 2025.
- Results publication: PubMed 27185681Yumul R, Elvir-Lazo OL, White PF, Sloninsky A, Kaplan M, Kariger R, Naruse R, Parker N, Pham C, Zhang X, Wender RH. Comparison of three video laryngoscopy devices to direct laryngoscopy for intubating obese patients: a randomized controlled trial. J Clin Anesth. 2016 Jun;31:71-7. doi: 10.1016/j.jclinane.2015.12.042. Epub 2016 Mar 23.
- Individual participant dataSharing planned: No. Participatned did not agree
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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 measurment of intubation time in seconds in people with Intubating Laryngeal Airway, run by Jagiellonian University at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 4 Jun 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 Poland. 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?
determine whether modern technologies such as videolaryngoscopy shorten intubation time. (time frame: 1 day). 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 NCT07004621, which also lists 1 linked publication.
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 4 Jun 2025.