UrolithiasisNCT07555535
Videolaryngoscope vs VideoLMA for Endotracheal Intubation in RIRS
A study testing Videolaryngoscope and VideoLMA in people with Urolithiasis and Airway Management, run by Ela Erdem Hıdiroglu at 1 site in Turkey (Türkiye).
Trial summary
This study is a prospective, randomized, parallel-group clinical trial comparing videolaryngoscope and videoLMA for endotracheal intubation in adult patients undergoing surgery. Patients will be randomly assigned into two groups. The primary outcome is intubation time. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Urolithiasis, Airway Management
- What is being tested?
- Videolaryngoscope and VideoLMA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 Apr 2026to 14 Jun 2026
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults aged 18 years and older ASA physical status I-III Patients scheduled for surgery requiring endotracheal intubation Ability to provide written informed consent
Who cannot join
- History of tracheostomy Known or predicted difficult airway Presence of oral mass or tumor Pregnant patients Patients unable to provide informed consent Patients requiring reoperation within 24 hours
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Etlik city hospital
Yenimahalle, Ankara, 06000
About this study
Official title: Comparison of Videolaryngoscope and VideoLMA for Endotracheal Intubation in Patients Undergoing Retrograde Intrarenal Surgery: A Randomized Controlled Trial
This study is a prospective, randomized, parallel-group clinical trial comparing videolaryngoscope and videoLMA for endotracheal intubation in adult patients undergoing surgery. Patients will be randomly assigned into two groups. The primary outcome is intubation time. Secondary outcomes include first attempt success rate, number of attempts, oxygen desaturation, hemodynamic changes, and postoperative complications.
Read the detailed description
Airway management is a critical component of anesthesia practice. Videolaryngoscopes and videoLMA devices are widely used tools for endotracheal intubation. While videolaryngoscopes provide improved visualization of the glottis, videoLMA devices can facilitate both airway management and guided intubation.
In this prospective randomized study, 100 patients will be assigned to either videolaryngoscope or videoLMA groups. Standard anesthesia induction will be applied. Intubation time, success rates, hemodynamic responses, and complications will be recorded and analyzed.
- Conditions
- Urolithiasis, Airway Management
- Being tested
- Videolaryngoscope, VideoLMA
- Medical subject headings
- Urolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VideolaryngoscopeDevice
Patients undergoing endotracheal intubation using videolaryngoscope
VideoLMADevice
Patients undergoing endotracheal intubation using videoLMA
| Study group | Role | What they receive |
|---|---|---|
| Videolaryngoscope Group | Experimental | Patients undergoing endotracheal intubation using videolaryngoscope Receives: Device: Videolaryngoscope |
| VideoLMA Group | Experimental | Patients undergoing endotracheal intubation using videoLMA Receives: Device: VideoLMA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intubation Time
Time from insertion of the airway device into the patient's mouth until successful placement of the endotracheal tube, confirmed by continuous capnography.
Measured: From insertion of the airway device to confirmation of endotracheal tube placement (during anesthesia induction, within approximately 0-5 minutes)
Secondary outcomes (8)
First Attempt Success
Successful placement of the endotracheal tube on the first attempt without the need for additional airway maneuvers.
Measured: During first intubation attempt (within 0-2 minutes)
Number of Attempts
Total number of attempts required to achieve successful endotracheal intubation.
Measured: During intubation procedure (within approximately 0-10 minutes
Oxygen Desaturation
Occurrence of oxygen desaturation defined as peripheral oxygen saturation (SpO₂) below 92% during the intubation procedure.
Measured: During intubation procedure (from induction until successful intubation, approximately 0-10 minutes)
Heart rate
changes in heart rate measured at predefined time points
Measured: At baseline (pre-induction), immediately after intubation, and at 1, 3, and 5 minutes post-intubation
Postoperative Sore Throat
Presence of sore throat assessed using a standardized patient-reported scale.
Measured: At postoperative 1 hour and 2 hours
Hoarseness
Presence of voice changes (hoarseness) assessed based on patient self-report.
Measured: At postoperative 1 hour and 2 hours
Complications
Occurrence of airway-related complications including mucosal injury, dental trauma, or esophageal intubation observed during the procedure.
Measured: During intubation and intraoperative period (approximately 0-60 minutes)
mean arterial pressure
changes in mean arterial pressure measured at predefined time points
Measured: baseline, post intubation,1,3,5 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2026
- Study start28 Apr 2026
- Primary completion30 May 2026
- Study completion14 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UrolithiasisStudies 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ela Erdem Hıdiroglu
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Ela Erdem Hıdiroglu, Ankara Etlik City Hospital
- Investigators
- Ela Erdem Hidiroglu, MD, Principal investigator, Ankara Etlik City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07555535
- Sponsor's protocol ID
- AEŞH-EK1-2025-296
- Status last verified
- Apr 2026
- First submitted
- 7 Apr 2026
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Videolaryngoscope and VideoLMA for Endotracheal Intubation in Patients Undergoing Retrograde Intrarenal Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07555535
- Acronym / sponsor ID
- AEŞH-EK1-2025-296
- Conditions
- Urolithiasis, Airway Management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Ela Erdem HıdirogluOther government
- Study start
- 28 Apr 2026 (actual)
- Primary completion
- 30 May 2026 (actual)
- Study completion
- 14 Jun 2026 (actual)
- First posted
- 29 Apr 2026 (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.
This study is a prospective, randomized, parallel-group clinical trial comparing videolaryngoscope and videoLMA for endotracheal intubation in adult patients undergoing surgery. Patients will be randomly assigned into two groups. The primary outcome is intubation time. Secondary outcomes include first attempt success rate, number of attempts, oxygen desaturation, hemodynamic changes, and postoperative complications.
Detailed description
Airway management is a critical component of anesthesia practice. Videolaryngoscopes and videoLMA devices are widely used tools for endotracheal intubation. While videolaryngoscopes provide improved visualization of the glottis, videoLMA devices can facilitate both airway management and guided intubation.
In this prospective randomized study, 100 patients will be assigned to either videolaryngoscope or videoLMA groups. Standard anesthesia induction will be applied. Intubation time, success rates, hemodynamic responses, and complications will be recorded and analyzed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Videolaryngoscope Group | Experimental | Device: VideolaryngoscopePatients undergoing endotracheal intubation using videolaryngoscope |
| VideoLMA Group | Experimental | Device: VideoLMAPatients undergoing endotracheal intubation using videoLMA |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults aged 18 years and older ASA physical status I-III Patients scheduled for surgery requiring endotracheal intubation Ability to provide written informed consent
Key exclusion criteria (1 listed)
- History of tracheostomy Known or predicted difficult airway Presence of oral mass or tumor Pregnant patients Patients unable to provide informed consent Patients requiring reoperation within 24 hours
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 |
|---|---|---|
| VideolaryngoscopePatients undergoing endotracheal intubation using videolaryngoscope | Device | Videolaryngoscope Group |
| VideoLMAPatients undergoing endotracheal intubation using videoLMA | Device | VideoLMA Group |
Primary outcome
Intubation Time
Time frame: From insertion of the airway device to confirmation of endotracheal tube placement (during anesthesia induction, within approximately 0-5 minutes)
Time from insertion of the airway device into the patient's mouth until successful placement of the endotracheal tube, confirmed by continuous capnography.
8 secondary outcomes
First Attempt Success
Time frame: During first intubation attempt (within 0-2 minutes)
Number of Attempts
Time frame: During intubation procedure (within approximately 0-10 minutes
Oxygen Desaturation
Time frame: During intubation procedure (from induction until successful intubation, approximately 0-10 minutes)
Heart rate
Time frame: At baseline (pre-induction), immediately after intubation, and at 1, 3, and 5 minutes post-intubation
Postoperative Sore Throat
Time frame: At postoperative 1 hour and 2 hours
Hoarseness
Time frame: At postoperative 1 hour and 2 hours
Complications
Time frame: During intubation and intraoperative period (approximately 0-60 minutes)
mean arterial pressure
Time frame: baseline, post intubation,1,3,5 min
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 16 Jun 2026.
- 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.
Ela Erdem Hidiroglu, MD principal investigator
Ankara Etlik City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Videolaryngoscope and VideoLMA in people with Urolithiasis and Airway Management, run by Ela Erdem Hıdiroglu at 1 site in Turkey (Türkiye).
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 1 inclusion and 1 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 16 Jun 2026. 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 Turkey (Türkiye). 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?
Intubation Time (time frame: From insertion of the airway device to confirmation of endotracheal tube placement (during anesthesia induction, within approximately 0-5 minutes)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Jun 2026.