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

Not Applicable

Recruiting

• Conditions: Mechanical Ventilation

• Registration Number: NCT06474559
• Lead Sponsor: University Hospital of Patras

Brief Summary

The aim of this prospective, randomized, comparative, controlled clinical study is to compare laryngeal mask airway ProtectorTM with the endotracheal tube, regarding to the respiratory mechanical parameters during controlled mechanical ventilation and the prevalence of aspiration. Aspiration will be evaluated by detecting and quantifying pepsin (a marker of gastric aspiration) and α-amylase (a marker of salivary aspiration) in the bronchoalveolar lavage ( mini BAL) of patients ≥18 years old, ASA 1-2, undergoing selective low-risk surgery under general anesthesia in a lithotomy position.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-06
• Study Start: 2024-06
• Study First Submitted: 2024-06-05
• Study First Submitted QC: 2024-06-19
• Last Update Submitted: 2024-06-19
• Study First Posted: 2024-06-25
• Last Update Posted: 2024-06-25
• Primary Completion: 2024-10-01
• Study Completion: 2025-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Difference in PIP cmH20 (Peak inspiratory pressure ) between the two groups of patients.	Intraoperative	Measured by Ventilator
Assessment of aspiration risk by quantitative measurements of pepsin (ng/ml) and α-amylase (IU/ml) in BAL of patients and differences in its incidence between the two groups.	through study completion, an average of 1 year	Measured by ELISA method

Secondary Outcome Measures

Name	Time	Method
Differences in lung mechanics between the two patient groups	Intraoperative	Pplat cmH20( plataeu pressure) Dynamic Compliance ml/cmH20 , MAP cmH20( Mean Airway pressure ), PEEP cmH20,( positive end-expiratory pressure VTins, VTexp ( t, Raw cmH20/ml/sec( resistance of airway), ΔP cmH20(Driving Pressure, inspired (VTinsp) and expired (VTexp) tidal volumes, VTins - VTexp.

Trial Locations

Locations (1)

General Univerisity Hospital of Patras; 🇬🇷 Patras, Greece