Effects of NIV and CPAP on Ventilation Distribution, Measured by EIT, During Deep Sedation in Paediatric Patients (NIVEIT-ped)

August 8, 2022 updated by: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Effects of Non-invasive Ventilation (NIV) and Continuous Positive Airway Pressure (CPAP) on Ventilation Distribution, Measured by Electrical Impedance Tomography (EIT), During Deep Sedation in Paediatric Patients

In patients undergoing spontaneous breathing (SB) deep sedation there is a re-distribution of ventilation towards lungs non-dependant areas (ventral areas in supine position).

Non-invasive ventilation (NIV), offering positive pressure, should favour a better ventilation of dependant areas (dorsal areas in supine position), making ventilation more homogeneous and increasing functional residual capacity.

Electrical impedance tomography (EIT) is a non-invasive, non-operator dependent, bedside, radiations-free diagnostic tool, feasible in paediatric patients and repeatable; it allows to study ventilation distribution, and it can measure and calculate also parameters that are related to the homogeneity of ventilation and the response to certain therapeutic maneuvers, such as anaesthesia or PEEP-application.

Uses of EIT in paediatric age are described in literature, but it has never been described as being used in Non-Operating Room Anaesthesia, nor in other cases of SB deep sedation. In addition, the impact of NIV on the distribution of ventilation in healthy paediatric patients undergoing deep sedation has never been described.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

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

  • Italy
      • Milan, Italy, 20122
        • Recruiting
        • Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico Milano
        • Principal Investigator:
          • Giovanna Chidini, MD
        • Contact:
        • Sub-Investigator:
          • Veronica D'oria, RD
        • Sub-Investigator:
          • Stefano Scalia Catenacci, MD
        • Sub-Investigator:
          • Tiziana Marchesi, MD
        • Sub-Investigator:
          • Cinzia Montani, MD
        • Sub-Investigator:
          • Giada Donà, MD
        • Sub-Investigator:
          • Ludovica Ughi, 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

1 year to 10 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Paediatric age (from 1 to 10 years old)
  • ASA score ≤ 2
  • Sedation time ≥ 30 min

Exclusion Criteria:

  • ASA score ≥ 3
  • Lung pathologies (such as asthma, bronchopulmonary dysplasia, obstructive sleep apnoea) Preterm infant
  • Severe obesity
  • Dorso-lumbar pathologies or other bone pathologies associated with restrictive lung disease (such as scoliosis, kyphosis)
  • Neuromuscular, mitochondrial, metabolic or chromosomal disease with hypotonia
  • CPAP or NIV treatment at home
  • Hand-Bag Ventilation (HBV) during the procedure (loss of the respiratory drive)
  • Non-Total IntraVenous Anaesthesia (TIVA), adherence to the sedation protocol
  • Implantable devices not compatible with EIT (such as pace-makers and implantable cardioverter defibrillator)

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Spontaneous breathing
Electrical impedance tomography (EIT).
Device: EIT
Evaluation of ventilation distrinution during deep sedation through EIT
Active Comparator: CPAP mode
Electrical impedance tomography (EIT).
Device: EIT
Evaluation of ventilation distrinution during deep sedation through EIT
Active Comparator: NIV- S/T mode
Electrical impedance tomography (EIT).
Device: EIT
Evaluation of ventilation distrinution during deep sedation through EIT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Regional Ventilation Delay (pixels %), RDV
Time Frame: 1 day
It's an index of atelectrauma, supra-distension and in general an inhomogeneous ventilation
1 day

Secondary Outcome Measures

Outcome Measure
Time Frame
Inhomogeneity Index (pixels), GI
Time Frame: 1 day
1 day
Gravity Centre(pixels %), GC
Time Frame: 1 day
1 day

Collaborators and Investigators

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

Sponsor

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Investigators

  • Principal Investigator: Giovanna Chidini, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Milano

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)

April 20, 2021

Primary Completion (Anticipated)

June 28, 2023

Study Completion (Anticipated)

October 30, 2024

Study Registration Dates

First Submitted

February 25, 2022

First Submitted That Met QC Criteria

August 8, 2022

First Posted (Actual)

August 10, 2022

Study Record Updates

Last Update Posted (Actual)

August 10, 2022

Last Update Submitted That Met QC Criteria

August 8, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021/2178

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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