- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07688954
Difficult Intubation in HoLEP Surgery
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?
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 Overview
Status
Study Type
Enrollment (Estimated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
HoLEP Patients
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
|
Intraoperative period
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Risk Factors for Difficult Intubation
Time Frame: Preoperative and intraoperative periods
|
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
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- TABED1-26-2748
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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