NCT07688954

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
5mo left

Started Jul 2026

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress15%
Jul 2026Dec 2026

First Submitted

Initial submission to the registry

June 30, 2026

Completed
5 days until next milestone

Study Start

First participant enrolled

July 5, 2026

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 7, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2026

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

July 7, 2026

Status Verified

June 1, 2026

Enrollment Period

2 months

First QC Date

June 30, 2026

Last Update Submit

June 30, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • Risk Factors for Difficult Intubation

    Preoperative and intraoperative periods

Study Arms (1)

HoLEP Patients

Eligibility Criteria

Age18 Years+
Sexmale
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who underwent elective HoLEP surgery under general anesthesia

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assos prof

Study Record Dates

First Submitted

June 30, 2026

First Posted

July 7, 2026

Study Start

July 5, 2026

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

July 7, 2026

Record last verified: 2026-06