Difficult Intubation in HoLEP Surgery | NCT07688954

Studies
Difficult Intubation in HoLEP Surgery

NCT07688954

Sponsor

Ankara City Hospital Bilkent

Status

Not yet recruiting

Last Update Posted

Jul 7, 2026Actual

Enrollment

300Estimated

Phase

Not provided

Conditions

Difficult Intubation
Holmium Laser Enucleation of the Prostate

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 5, 2026Estimated

Primary Completion Date

Aug 31, 2026Estimated

Completion Date

Dec 31, 2026Estimated

First Submitted Date

Jun 30, 2026

First Submission Date that Met QC Criteria

Jun 30, 2026

First Posted Date

Jul 7, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 30, 2026

Last Update Posted Date

Jul 7, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

300Estimated

Label	Type	Description	Intervention Names
HoLEP Patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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).	Intraoperative period

Secondary Outcomes

Measure	Description	Time Frame
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	Preoperative and intraoperative periods

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients aged over 18 years Underwent elective HoLEP (Holmium Laser Enucleation of the Prostate) surgery Received general anesthesia

Exclusion Criteria:

Emergency surgery Missing or incomplete anesthesia records Pre-existing known advanced airway anomalies History of tracheostomy

Accepts Healthy Volunteers

Not provided

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients who underwent elective HoLEP surgery under general anesthesia

Sampling Method

Non-Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided