Changes in Pulmonary Ventilation Distribution Assessed by Electrical Impedance Tomography in Healthy Children Under General Anesthesia (EIT_ped)

February 19, 2024 updated by: Queen Fabiola Children's University Hospital

Changes in Pulmonary Ventilation Distribution Assessed by EIT (Electrical Impedance Tomography) in Healthy Children Under General Anesthesia; a Pilot Study Comparing Mask Spontaneous Breathing and Laryngeal Mask Spontaneous Breathing With and Without Ventilatory Support

The incidence of atelectasis is high in patients undergoing general anesthesia. This may cause oxygenation impairment and further contribute to post-operative pulmonary complications. As important airway management devices for general anesthesia, few studies have compared the impact of laryngeal mask airway and spontaneous breathing on atelectasis. Through the study, the distribution of the pulmonary ventilation of children undergoing an elective and standard procedure in our center (H.U.D.E.R.F.) will be studied using electric impedance tomography.

Children from 1 year-old to 6-year-old, ASA physical status I or II who will undergo elective circumcisions under general anesthesia associated with regional anesthesia (Penile Block10) at the One Day Clinic of H.U.D.E.R.F. (Hôpital des Enfants Reine Fabiola - Brussels - Belgium).

Patients will be allocated to three different group in a ration of 1:1:1.

  • Group 1: spontaneous mask ventilation (20 patients).
  • Group 2: spontaneous laryngeal mask (LMA) ventilation (20 patients).
  • Group 3: spontaneous-pressure support LMA ventilation (LMA SV-PS) (20 patients).
  • Standard monitoring for the inductions of the anesthesia will include non-invasive blood pressure (NIBP), pulse oximetry (SpO2), Electrocardiogram (ECG), End-Tidal CO2 (EtCO2), End Tidal Sevoflurane concentration (EtSev %), inspired fraction of oxygen (FiO2), body temperature (rectal thermometer).

Induction is based as well on the local routine protocols using an inhalation induction of the patient with Sevoflurane (Fet of 6-8%) and a recommended FiO2 from 80-90% maximum until the stabilization of the induction. Then the FiO2 will be decreased at least under 40% and Sevoflurane adapted to the need of the deepness of the anesthesia (both at the discretion of the anesthesiologist in charge of the patient).

Depending on the randomization, the patient will undergo the surgery either with spontaneous face mask ventilation (group 1), LMA spontaneous ventilation (group 2), or LMA SV-PS (group 3) (during which the pressure support will be adapted at the discretion of the anesthesiologist but with a tidal volume included in the range of 6-10ml/kg).

Electrical impedance tomography measurements:

The effects of the spontaneous breathing (mask ventilation or LMA) or the pressure support ventilation (LMA SV-PS) on atelectasis formations and the distribution of the ventilation will be assessed using electrical impedance tomography.

The device used during the study will be the "PulmoVista 500"; it will be provided by Dräger (Lübeck, Germany) free of charge and without any obligation or results/conclusions requested by Dräger. The device is approved CE (European regulation) and will be used in the conditions for which it has been designed.

A reusable belt with 16 evenly spaced electrodes will be placed around the chest of each patient included in the study between the 4th and 6th ribs as recommended by Dräger.

The EIT measurements will be taken of 4 different moments:

T1: Before induction of the anesthesia in the preoperatory waiting room (and at least 30 min after the premedication).

T2: After the induction of anesthesia (GA and penile block), just before the beginning of the surgical procedure.

T3: After the end of the surgical procedure, just before discontinuing the general anesthesia.

T4: Before the discharge of the PACU.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

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, Belgium, 1020
        • Recruiting
        • H.U.B - Hôpital Universitaire des Enfants Reine Fabiola
        • Contact:

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

Description

Inclusion Criteria:

  • Children undergoing elective circumcision
  • Age 1 to 6 years
  • ASA class I or II

Exclusion Criteria:

  • Any history of lung diseases, congenital heart diseases or abdominal diseases that could interfere with lungs dynamic.
  • ASA physical status11 > II.
  • Patients whose weight is less than 10 kg.
  • The use of Jackson-Rees device12.
  • Contraindication for premedication.
  • Contraindication for mask ventilation or laryngeal mask ventilation13.
  • Contraindication for regional anesthesia.
  • Need for opioids administration during surgery.
  • Patients with uncontrollable movements of the body.
  • Inability of parents/tutors to understand French or Dutch.
  • Patients whose parents do not agree with their participation in the study
  • Patients with thoracic perimeters (between 4th and 6th ribs) less than 37.5 cm (minimal size for the pediatric EIT belt) or more than 72 cm (maximal size for the pediatric EIT belt)
  • Patients with damaged skin or impaired skin contact of the electrodes due to wound dressings.
  • Patients with spinal lesions or fractures (acute or recent)
  • Patients with pacemaker, defibrillators, or other electrically active implants

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

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: General anesthesia with spontaneous mask ventilation
Patients under general anesthesia with spontaneous mask ventilation
Procedure: General anesthesia with mask ventilation
Randomization to General anesthesia with mask ventilation
Experimental: General anesthesia and spontaneous laryngeal mask ventilation
Patients under general anesthesia and spontaneous laryngeal mask ventilation
Procedure: General anesthesia and spontaneous laryngeal mask ventilation
Randomization to General anesthesia and spontaneous laryngeal mask ventilation
Experimental: General anesthesia with spontaneous laryngeal mask ventilation with pressure support
Patients under general anesthesia with spontaneous laryngeal mask ventilation with pressure support
Procedure: General anesthesia with spontaneous laryngeal mask ventilation with pressure support
Randomization to General anesthesia with spontaneous laryngeal mask ventilation with pressure support

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Variation of poorly ventilated pulmonary zones
Time Frame: 4 hours
Primary outcome will be the variation of poorly ventilated zones between period T1 (before induction of anesthesia) and period T2 (at the discharge from the PACU) that we may surrogate as atelectasis. The Pulmovista device divides the lungs in 4 areas (front to back in a supine patient) and the percentage of ventilation going to each area is measure by electric impedance variation. The difference in the distribution between the 4 areas will be measured (expressed as % of total ventilation).
4 hours

Collaborators and Investigators

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

Sponsor

Queen Fabiola Children's University Hospital

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 (Actual)

February 16, 2024

Primary Completion (Estimated)

June 30, 2024

Study Completion (Estimated)

September 30, 2024

Study Registration Dates

First Submitted

February 6, 2024

First Submitted That Met QC Criteria

February 14, 2024

First Posted (Actual)

February 16, 2024

Study Record Updates

Last Update Posted (Estimated)

February 21, 2024

Last Update Submitted That Met QC Criteria

February 19, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P2023457

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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