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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-30

Study Completion Date

2025-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Mechanical Ventilation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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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 colected at the end of the procedure

Group Type EXPERIMENTAL

LMA Protector

Intervention Type DEVICE

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

Endotracheal tube

Intervention Type DEVICE

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

Endotracheal tube

Patients will be intubated after standard anesthesia induction.The view of the larynx will be assessed ( Cormack Lehane system).Mini bronchoalveolar lavage will be colected at the end of the procedure

Group Type EXPERIMENTAL

LMA Protector

Intervention Type DEVICE

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

Endotracheal tube

Intervention Type DEVICE

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

Interventions

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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

Intervention Type 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

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes