- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07555535
Videolaryngoscope vs VideoLMA for Endotracheal Intubation in RIRS
Comparison of Videolaryngoscope and VideoLMA for Endotracheal Intubation in Patients Undergoing Retrograde Intrarenal Surgery: A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ela Erdem Hidiroglu, MD
- Phone Number: +90 534 887 41 84
- Email: drelaerdem@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Adults aged 18 years and older ASA physical status I-III Patients scheduled for surgery requiring endotracheal intubation Ability to provide written informed consent
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Videolaryngoscope Group
Patients undergoing endotracheal intubation using videolaryngoscope
|
Patients undergoing endotracheal intubation using videolaryngoscope
|
|
Experimental: VideoLMA Group
Patients undergoing endotracheal intubation using videoLMA
|
Patients undergoing endotracheal intubation using videoLMA
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
From insertion of the airway device to confirmation of endotracheal tube placement (during anesthesia induction, within approximately 0-5 minutes)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
First Attempt Success
Time Frame: During first intubation attempt (within 0-2 minutes)
|
Successful placement of the endotracheal tube on the first attempt without the need for additional airway maneuvers.
|
During first intubation attempt (within 0-2 minutes)
|
|
Number of Attempts
Time Frame: During intubation procedure (within approximately 0-10 minutes
|
Total number of attempts required to achieve successful endotracheal intubation.
|
During intubation procedure (within approximately 0-10 minutes
|
|
Oxygen Desaturation
Time Frame: During intubation procedure (from induction until successful intubation, approximately 0-10 minutes)
|
Occurrence of oxygen desaturation defined as peripheral oxygen saturation (SpO₂) below 92% during the intubation procedure.
|
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
|
changes in heart rate measured at predefined time points
|
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
|
Presence of sore throat assessed using a standardized patient-reported scale.
|
At postoperative 1 hour and 2 hours
|
|
Hoarseness
Time Frame: At postoperative 1 hour and 2 hours
|
Presence of voice changes (hoarseness) assessed based on patient self-report.
|
At postoperative 1 hour and 2 hours
|
|
Complications
Time Frame: During intubation and intraoperative period (approximately 0-60 minutes)
|
Occurrence of airway-related complications including mucosal injury, dental trauma, or esophageal intubation observed during the procedure.
|
During intubation and intraoperative period (approximately 0-60 minutes)
|
|
mean arterial pressure
Time Frame: baseline, post intubation,1,3,5 min
|
changes in mean arterial pressure measured at predefined time points
|
baseline, post intubation,1,3,5 min
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ela Erdem Hidiroglu, MD, Ankara Etlik City Hospital
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- AEŞH-EK1-2025-296
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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