Comparing Laryngeal Mask Airway with Endotracheal Tube for Ventilation

Comparison of Protector Laryngeal Mask With Endotracheal Tube: Evaluation of Respiratory Mechanical Parameters During Controlled Ventilation & Possibility of Pulmonary Aspiration

This study is testing whether a new breathing device works better than the standard tube for patients having low-risk urological surgeries under general anesthesia.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University Hospital of Patras (Academic / other)
• Locations: 1 site (Pátrai)
• Trial ID: NCT06474559 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to compare the effectiveness of the Laryngeal Mask Airway Protector with the traditional endotracheal tube during controlled mechanical ventilation in patients undergoing low-risk urological surgeries. It will evaluate respiratory mechanical parameters and the prevalence of pulmonary aspiration by measuring specific biomarkers in bronchoalveolar lavage. The study will involve patients aged 18 and older who are classified as ASA 1-2 and will be conducted under general anesthesia in a lithotomy position.

Who should consider this trial

Good fit: Ideal candidates are patients aged 18 and older, classified as ASA 1-2, scheduled for elective low-risk urological surgery under general anesthesia.

Not a fit: Patients under 18, those undergoing emergency surgeries, or individuals with contraindications for LMA placement will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve ventilation strategies and reduce the risk of pulmonary aspiration during surgeries.

How similar studies have performed: Similar studies have shown varying degrees of success in comparing airway management techniques, but this specific comparison is less commonly tested.

Eligibility criteria

Inclusion Criteria:

* Patients aged ≥18 years ASA1-2 who are to undergo planned urological surgery of low or intermediate severity, under general anesthesia in the lithotomy position.

Exclusion Criteria:

* patients \< 18 years old.
* Patients who are going to undergo an emergency/urgent operation/ trauma patients.
* Maternal population.
* Patients who are not scheduled to receive general anesthesia, but some other type of anesthesia.
* Patients in whom LMA placement is contraindicated, such as patients at high risk for reflux and aspiration of gastric contents (eg, history of gastroesophageal reflux, hiatal hernia, pyloric stenosis, gastrointestinal obstruction, morbid obesity).
* Patients who meet at least one of the four RODS difficulty criteria.
* Contraindicated patients: administration of neuromuscular blockade, suppression of spontaneous respiration, and those with an indication for awake intubation or surgical airway.
* Patients who refuse to participate in the study.

Where this trial is running

Pátrai

• General Univerisity Hospital of Patras — Pátrai, Greece (Recruiting)

Study contacts

• Study coordinator: Stella Antoniou, MD

Conditions Mechanical Ventilation