Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
ID06474559

Comparison of Protector Laryngeal Mask 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

21 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are comparing two airway management devices, the Laryngeal Mask Airway (LMA) Protector and the endotracheal tube, in adults aged 18 years and older undergoing planned urological surgeries of low or intermediate severity under general anesthesia. The study aims to evaluate differences in respiratory mechanical parameters during controlled mechanical ventilation and assess the risk of pulmonary aspiration by measuring pepsin and alpha-amylase levels in bronchoalveolar lavage samples. This prospective, randomized, controlled trial is led by the University Hospital of Patras. Participants will be randomly assigned to receive either the LMA Protector or an endotracheal tube after standard anesthesia induction. The larynx view will be assessed using a fiberoptic grading scale for the LMA Protector group and the Cormack Lehane system for the endotracheal tube group. Mini bronchoalveolar lavage samples will be collected at the end of the surgical procedure to detect markers of aspiration. During the study, respiratory mechanics such as peak inspiratory pressure will be measured intraoperatively. Researchers will analyze the lavage samples for pepsin and alpha-amylase to assess aspiration risk throughout the study, which will continue for about one year. The trial involves standard anesthesia procedures and airway assessments, with safety and mechanical ventilation parameters closely monitored. Participation includes surgery under anesthesia, airway device placement, airway visualization, and sample collection for laboratory analysis.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged 18 years or older
  • Patients with ASA score 1 or 2
  • Scheduled for planned urological surgery of low or intermediate severity
  • General anesthesia planned in the lithotomy position
Not Eligible

You will not qualify if you...

  • Patients younger than 18 years old
  • Emergency or urgent surgery patients
  • Trauma patients
  • Pregnant or maternal population
  • Patients not receiving general anesthesia
  • Patients with contraindications for LMA placement such as high risk of reflux or aspiration (e.g., history of gastroesophageal reflux, hiatal hernia, pyloric stenosis, gastrointestinal obstruction, 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

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Implementation

Duration - Duration of the surgery procedure

Participants receive either the LMA Protector or Endotracheal tube after standard anesthesia induction during planned urological surgery. Respiratory parameters and larynx view are assessed during the procedure.

1 visit (in-person) during surgery

Long-term Monitoring

Duration - Up to 1 year after surgery

Participants are monitored for aspiration risk and lung mechanics differences through quantitative measurements and follow-up assessments.

Trial Site Locations

Total: 1 location

1

General Univerisity Hospital of Patras

Pátrai, Greece

Actively Recruiting

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Research Team

S

Stella Antoniou, MD

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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