Difficult IntubationNCT07688954
Difficult Intubation in HoLEP Surgery
An observational study of Difficult Intubation and Holmium Laser Enucleation of the Prostate, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
The goal of this observational study is to determine the incidence of difficult intubation and evaluate the associated clinical risk factors in patients undergoing Holmium Laser Enucleation of the Prostate (HoLEP) surgery under general anesthesia. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Difficult Intubation, Holmium Laser Enucleation of the Prostate
- How many people
- 700 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Jul 2026to 15 Sep 2026
- Phase
- Observational
- 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
- Men only
- Adult, Older adult
Study population: Patients who underwent elective HoLEP surgery under general anesthesia
Who may be able to join
- Patients aged over 18 years Underwent elective HoLEP (Holmium Laser Enucleation of the Prostate) surgery Received general anesthesia
Who cannot join
- Emergency surgery Missing or incomplete anesthesia records Pre-existing known advanced airway anomalies History of tracheostomy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Retrospective Evaluation of Difficult Intubation Incidence and Associated Risk Factors in Holmium Laser Enucleation of the Prostate (HoLEP) Surgery
The goal of this observational study is to determine the incidence of difficult intubation and evaluate the associated clinical risk factors in patients undergoing Holmium Laser Enucleation of the Prostate (HoLEP) surgery under general anesthesia. The main questions it aims to answer are:
What is the incidence of difficult intubation among patients undergoing HoLEP surgery? Are clinical parameters such as increased BMI, alpha-blocker use, high prostate volume, high ASA score, and high Mallampati class independent risk factors for difficult intubation in this specific patient population?
Read more
Participants' data will be evaluated retrospectively, and the study involves the following tasks based on medical records:
Reviewing preoperative demographic and clinical data including age, BMI, ASA score, comorbid diseases, alpha-blocker use, smoking history, and Mallampati class.
Extracting intraoperative airway management data such as Cormack-Lehane score, number of intubation attempts, and the use of alternative devices like videolaryngoscopes or gum elastic bougies.
Analyzing surgical parameters including prostate volume and total operation duration to identify their relationship with intubation outcomes.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| HoLEP Patients | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Difficult Intubation
Percentage of patients who experienced difficult intubation (defined by Cormack-Lehane score, number of intubation attempts, or use of alternative airway devices like videolaryngoscope/buji).
Measured: Intraoperative period
Secondary outcomes (1)
Risk Factors for Difficult Intubation
Association of clinical and demographic parameters (including BMI, alpha-blocker use, prostate volume, ASA score, and Mallampati class) with the occurrence of difficult intubation
Measured: Preoperative and intraoperative periods
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2026
- Study start5 Jul 2026
- Primary completion31 Jul 2026
- Study completion15 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Difficult IntubationStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 700 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Betül Güven, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07688954
- Sponsor's protocol ID
- TABED1-26-2748
- Status last verified
- Oct 2026
- First submitted
- 30 Jun 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Evaluation of Difficult Intubation Incidence and Associated Risk Factors in Holmium Laser Enucleation of the Prostate (HoLEP) Surgery
- ClinicalTrials.gov ID
- NCT07688954
- Acronym / sponsor ID
- TABED1-26-2748
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 700 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 5 Jul 2026 (actual)
- Primary completion
- 31 Jul 2026 (actual)
- Study completion
- 15 Sep 2026 (actual)
- First posted
- 7 Jul 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.
The goal of this observational study is to determine the incidence of difficult intubation and evaluate the associated clinical risk factors in patients undergoing Holmium Laser Enucleation of the Prostate (HoLEP) surgery under general anesthesia. The main questions it aims to answer are:
What is the incidence of difficult intubation among patients undergoing HoLEP surgery? Are clinical parameters such as increased BMI, alpha-blocker use, high prostate volume, high ASA score, and high Mallampati class independent risk factors for difficult intubation in this specific patient population?
Participants' data will be evaluated retrospectively, and the study involves the following tasks based on medical records:
Reviewing preoperative demographic and clinical data including age, BMI, ASA score, comorbid diseases, alpha-blocker use, smoking history, and Mallampati class.
Extracting intraoperative airway management data such as Cormack-Lehane score, number of intubation attempts, and the use of alternative devices like videolaryngoscopes or gum elastic bougies.
Analyzing surgical parameters including prostate volume and total operation duration to identify their relationship with intubation outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HoLEP Patients | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent elective HoLEP surgery under general anesthesia
Key inclusion criteria (1 listed)
- Patients aged over 18 years Underwent elective HoLEP (Holmium Laser Enucleation of the Prostate) surgery Received general anesthesia
Key exclusion criteria (1 listed)
- Emergency surgery Missing or incomplete anesthesia records Pre-existing known advanced airway anomalies History of tracheostomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of Difficult Intubation
Time frame: Intraoperative period
Percentage of patients who experienced difficult intubation (defined by Cormack-Lehane score, number of intubation attempts, or use of alternative airway devices like videolaryngoscope/buji).
1 secondary outcome
Risk Factors for Difficult Intubation
Time frame: Preoperative and intraoperative periods
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 8 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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?
An observational study of Difficult Intubation and Holmium Laser Enucleation of the Prostate, run by Ankara City Hospital Bilkent 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 8 Oct 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?
Incidence of Difficult Intubation (time frame: Intraoperative period). 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 8 Oct 2026; AzTrials last refreshed its copy on 29 Oct 2026.