Urolithiasis, Airway Management
Conditions
Brief summary
This study is a prospective, randomized, parallel-group clinical trial comparing videolaryngoscope and videoLMA for endotracheal intubation in adult patients undergoing surgery. Patients will be randomly assigned into two groups. The primary outcome is intubation time. Secondary outcomes include first attempt success rate, number of attempts, oxygen desaturation, hemodynamic changes, and postoperative complications.
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.
Interventions
DEVICEVideolaryngoscope
Patients undergoing endotracheal intubation using videolaryngoscope
DEVICEVideoLMA
Patients undergoing endotracheal intubation using videoLMA
Sponsors
Ela Erdem Hıdiroglu
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
this study is conducted as an open label trial no masking is applied the clinicians performing the intubation and collecting the data are aware of the intervention
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intubation Time | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| First Attempt Success | 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. |
| Number of Attempts | During intubation procedure (within approximately 0-10 minutes | Total number of attempts required to achieve successful endotracheal intubation. |
| Oxygen Desaturation | 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. |
| Heart rate | 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 |
| Postoperative Sore Throat | At postoperative 1 hour and 2 hours | Presence of sore throat assessed using a standardized patient-reported scale. |
| Hoarseness | At postoperative 1 hour and 2 hours | Presence of voice changes (hoarseness) assessed based on patient self-report. |
| Complications | 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. |
| mean arterial pressure | baseline, post intubation,1,3,5 min | changes in mean arterial pressure measured at predefined time points |
Contacts
CONTACTEla Erdem Hidiroglu, MD
PRINCIPAL_INVESTIGATOREla Erdem Hidiroglu, MD
Ankara Etlik City Hospital
Outcome results
None listed