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

NCT06474559 | Recruiting

• 1 other identifier: Protector-1
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Mechanical Ventilation

Outcome Measures

Primary Outcomes (2)

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

  Measured by Ventilator

  Intraoperative

• 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

  through study completion, an average of 1 year

Secondary Outcomes (1)

• Differences in lung mechanics between the two patient groups

  Intraoperative

Study Arms (2)

LMA Protector

EXPERIMENTAL

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

Device: LMA Protector; Device: Endotracheal tube

Endotracheal tube

EXPERIMENTAL

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

Device: LMA Protector; Device: Endotracheal tube

Interventions

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; LMA Protector

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

Endotracheal tube; LMA Protector

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital of Patras: lead

Study Sites (1)

General Univerisity Hospital of Patras

Pátrai, Greece

RECRUITING

Central Study Contacts

Stella Antoniou, MD

CONTACT

+306994255120; stella_A@windowslive.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 5, 2024
• First Posted: June 25, 2024
• Study Start: June 1, 2024
• Primary Completion: October 1, 2024
• Study Completion: March 1, 2025
• Last Updated: June 25, 2024

Record last verified: 2024-06

Locations

GR (1)