Pulmonary Ultrasound for the Assessment of Atelectasis in Anesthetized Children Using a Laryngeal Mask Airway.

January 17, 2024 updated by: Centre Hospitalier Universitaire Saint Pierre

Pulmonary Ultrasound for the Assessment of Atelectasis in Anesthetized Children Using a Laryngeal Mask Airway: a Randomized Double-Blinded Controlled Trial That Compares Spontaneous and Pressure Support Ventilation

This study will use lung ultrasounds (LUS) to evaluate the incidence and severity of intraoperative atelectasis in anesthetized children undergoing minor surgery using a laryngeal mask airway. The children will be randomly assigned to be left in spontaneous ventilation with a Positive End Expiratory Pressure (PEEP) of 5cmH2O or to be ventilated with a pressure support mode.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

It is well known and described the deleterious effect that general anesthesia (GA) has on functional residual capacity (FRC), especially in children. This population is at higher risk of decreasing FRC during GA because of their lower capacity for elastic retraction and lower relaxation volume comparing to adults, predisposing them to the development of atelectasis and airway closure. These factors will lead to intrapulmonary shunts, which may impair the gas exchange and consequently oxygenation. By reducing the intrapulmonary shunt, Positive End Expiratory Pressure (PEEP) during controlled mechanical ventilation in patients with healthy lungs optimizes the FRC. However, the available data for an optimal ventilation strategy, including optimal PEEP, using a laryngeal mask airway (LMA) in the pediatric population are scarce, even though this device is frequently used in all age groups for brief general anesthesia.

Diagnosing anesthesia-induced atelectasis in the perioperative period can be possible by using lung ultrasounds (LUS), a simple, easily accessible, non-invasive and radiation free technique, which might help determine the impact in pulmonary aeration between different ventilation strategies. In our study, we will focus on comparing spontaneous ventilation (VS) with a PEEP of 5 cmH2O and pressure-support ventilation using a LMA in anesthetized children undergoing minor and elective outpatient surgery.

Study Type

Observational

Enrollment (Estimated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Belgium
    • Brussels
      • Brussel, Brussels, Belgium, 1000
        • Recruiting
        • Chu St. Pierre
        • Principal Investigator:
          • Andrea Carini, MD
        • Contact:
        • Sub-Investigator:
          • Mariana Carvalho, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Children aged between 12 months and 8 years scheduled for minor urologic surgery under general anesthesia.

Description

Inclusion Criteria:

  • fasted children between 12 months and 8 years of age; American Society of Anesthesiology (ASA) score I or II without lung disease; baseline pulse oximetry in room air >96%; scheduled for minor urological surgery (circumcision) under general anesthesia; written parent's agreement.

Exclusion Criteria:

  • ASA score > II, chronic lung disease, airway infection in the last 15 days, impossibility of insertion of LMA.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Spontaneous ventilation
Anesthetized Children ventilated with a laryngeal mask airway in spontaneous ventilation with a positive end expiratory pressure of 5cmH2O.
Diagnostic test: Lung Ultrasounds
An ultrasound exam of the lungs to identify possible areas of atelectasis.
Pressure support ventilation
Anesthetized Children ventilated with a laryngeal mask airway in pressure support ventilation with a positive end expiratory pressure of 5cmH2O, maximum pressure not exceeding 15cmH2O.
Diagnostic test: Lung Ultrasounds
An ultrasound exam of the lungs to identify possible areas of atelectasis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pulmonary aeration
Time Frame: during surgery and in the immediate postoperative period
Compare the Lung Aeration Score in the two groups
during surgery and in the immediate postoperative period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plethysmography
Time Frame: during surgery and in the immediate postoperative period.
Correlation between Lung Aeration Score and Plethysmography
during surgery and in the immediate postoperative period.
Ventilatory parameters
Time Frame: during surgery
Correlation between Lung Aeration Score and Ventilatory parameters
during surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire Saint Pierre

Investigators

  • Principal Investigator: Andrea Carini, MD, Resident in Anesthesiology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 15, 2024

Primary Completion (Estimated)

April 30, 2024

Study Completion (Estimated)

June 30, 2024

Study Registration Dates

First Submitted

December 4, 2023

First Submitted That Met QC Criteria

January 17, 2024

First Posted (Estimated)

January 19, 2024

Study Record Updates

Last Update Posted (Estimated)

January 19, 2024

Last Update Submitted That Met QC Criteria

January 17, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B0762023231006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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