Comparison of Protector Laryngeal Mask With Endotracheal Tube: Evaluation of Respiratory Mechanical Parameters During Controlled Ventilation & Possibility of Pulmonary Aspiration
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Mechanical Ventilation
- Sponsor
- University Hospital of Patras
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Difference in PIP cmH20 (Peak inspiratory pressure ) between the two groups of patients.
- Status
- Recruiting
- Last Updated
- last year
Overview
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.
Investigators
Stella Antoniou
MD
University Hospital of Patras
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.
Outcomes
Primary Outcomes
Difference in PIP cmH20 (Peak inspiratory pressure ) between the two groups of patients.
Time Frame: 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.
Time Frame: through study completion, an average of 1 year
Measured by ELISA method
Secondary Outcomes
- Differences in lung mechanics between the two patient groups(Intraoperative)