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

NCT06474559 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2024-06-25

No results posted yet for this study

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.

Conditions

  • Mechanical Ventilation

Interventions

DEVICE

LMA Protector

LMA Protector will be inserted by a researcher after standard anesthesia induction. The view of the larynx will be assessed using fiberoptic grading scale.Mini bronchoalveolar lavage will be collected before the end of the procedure

DEVICE

Endotracheal tube

tracheal intubation will be perform after standard anaesthetic induction. Cormack Lehane will be recorded. Mini bronchoalveolar lavage will be collected before the end of the procedure

Sponsors & Collaborators

  • University Hospital of Patras

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-06-30
Primary Completion
2024-10-01
Completion
2025-03-31

Countries

  • Greece

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06474559 on ClinicalTrials.gov