Actively Recruiting
Comparison of Lma-Protector With Endotracheal Tube: Evaluation of Respiratory Mechanical Parameters During Controlled Ventilation & Possibility of Pulmonary Aspiration
Led by University Hospital of Patras · Updated on 2024-06-25
80
Participants Needed
1
Research Sites
39 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Comparison of Lma-Protector With Endotracheal Tube: Evaluation of Respiratory Mechanical Parameters During Controlled Ventilation & Possibility of Pulmonary Aspiration
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 6518 years with ASA physical status 1 or 2
- Scheduled for planned urological surgery of low or intermediate severity
- Surgery performed under general anesthesia in the lithotomy position
You will not qualify if you...
- Patients younger than 18 years old
- Patients undergoing emergency or urgent operations or trauma patients
- Pregnant or maternal patients
- Patients not receiving general anesthesia
- Patients with contraindications to LMA placement, including high risk for reflux or aspiration such as history of gastroesophageal reflux, hiatal hernia, pyloric stenosis, gastrointestinal obstruction, or morbid obesity
- Patients meeting any of the four RODS difficulty criteria
- Patients requiring neuromuscular blockade, suppression of spontaneous respiration, awake intubation, or surgical airway
- Patients who refuse to participate in the study
AI-Screening
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Trial Site Locations
Total: 1 location
1
General Univerisity Hospital of Patras
Pátrai, Greece
Actively Recruiting
Research Team
S
Stella Antoniou, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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