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

ConditionMechanical Ventilation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital of Patras

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • LMA Protector

    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

    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

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: LMA ProtectorExperimental treatment 2 interventions
Group B: Endotracheal tubeExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Difference in PIP cmH20 (Peak inspiratory pressure ) between the two groups of patients.

Measured by Ventilator

Time frame
Intraoperative
2

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.

Measured by ELISA method

Time frame
through study completion, an average of 1 year

Secondary outcomes

1

Differences in lung mechanics between the two patient groups

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.

Time frame
Intraoperative

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital of Patras

Lead sponsor

Source ClinicalTrials.gov
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