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

Primary Purpose

Respiratory Failure, Sedation, Mechanical Ventilation Complication

Status

Recruiting

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

EIT

About this trial

This is an interventional treatment trial for Respiratory Failure focused on measuring NIV; CPAP; EIT;

Eligibility Criteria

1 Year - 10 Years (Child)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico MilanoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

Spontaneous breathing

CPAP mode

NIV- S/T mode

Arm Description

Electrical impedance tomography (EIT).

Outcomes

Primary Outcome Measures

Regional Ventilation Delay (pixels %), RDV

It's an index of atelectrauma, supra-distension and in general an inhomogeneous ventilation

Secondary Outcome Measures

Inhomogeneity Index (pixels), GI

Gravity Centre(pixels %), GC

Full Information

NCT ID

NCT05495477

First Posted

February 25, 2022

Last Updated

August 8, 2022

Sponsor

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

1. Study Identification

Unique Protocol Identification Number

NCT05495477

Brief Title

Effects of NIV and CPAP on Ventilation Distribution, Measured by EIT, During Deep Sedation in Paediatric Patients

Acronym

NIVEIT-ped

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Recruiting

Study Start Date

April 20, 2021 (Actual)

Primary Completion Date

June 28, 2023 (Anticipated)

Study Completion Date

October 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Respiratory Failure, Sedation, Mechanical Ventilation Complication

Keywords

NIV; CPAP; EIT;

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

Participant

Allocation

Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Spontaneous breathing

Arm Type

Active Comparator

Arm Description

Electrical impedance tomography (EIT).

Arm Title

CPAP mode

Arm Type

Active Comparator

Arm Description

Electrical impedance tomography (EIT).

Arm Title

NIV- S/T mode

Arm Type

Active Comparator

Arm Description

Electrical impedance tomography (EIT).

Intervention Type

Device

Intervention Name(s)

EIT

Intervention Description

Evaluation of ventilation distrinution during deep sedation through EIT

Primary Outcome Measure Information:

Title

Regional Ventilation Delay (pixels %), RDV

Description

It's an index of atelectrauma, supra-distension and in general an inhomogeneous ventilation

Time Frame

1 day

Secondary Outcome Measure Information:

Title

Inhomogeneity Index (pixels), GI

Time Frame

1 day

Title

Gravity Centre(pixels %), GC

Time Frame

1 day

10. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Year

Maximum Age & Unit of Time

10 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Giovanna Chidini, MD

Phone

0255032242

giovanna.chidini@policlinico.mi.it

First Name & Middle Initial & Last Name or Official Title & Degree

Stefano Scalia Catenacci, MD

Phone

0255032242

stefano.scaliacatenacci@policlinico.mi.it

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Giovanna Chidini

Organizational Affiliation

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Milano

Official's Role

Principal Investigator

Facility Information:

Facility Name

Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico Milano

City

Milan

ZIP/Postal Code

20122

Country

Italy

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Giovanna Chidini, MD

Phone

0255032242

giovanna.chidini@policlinico.mi.it

First Name & Middle Initial & Last Name & Degree

Giovanna Chidini, MD

First Name & Middle Initial & Last Name & Degree

Veronica D'oria, RD

First Name & Middle Initial & Last Name & Degree

Stefano Scalia Catenacci, MD

First Name & Middle Initial & Last Name & Degree

Tiziana Marchesi, MD

First Name & Middle Initial & Last Name & Degree

Cinzia Montani, MD

First Name & Middle Initial & Last Name & Degree

Giada Donà, MD

First Name & Middle Initial & Last Name & Degree

Ludovica Ughi, MD

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

22992946

Citation

Leonhardt S, Lachmann B. Electrical impedance tomography: the holy grail of ventilation and perfusion monitoring? Intensive Care Med. 2012 Dec;38(12):1917-29. doi: 10.1007/s00134-012-2684-z. Epub 2012 Sep 20.

Results Reference

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PubMed Identifier

19652949

Citation

Zhao Z, Moller K, Steinmann D, Frerichs I, Guttmann J. Evaluation of an electrical impedance tomography-based Global Inhomogeneity Index for pulmonary ventilation distribution. Intensive Care Med. 2009 Nov;35(11):1900-6. doi: 10.1007/s00134-009-1589-y. Epub 2009 Aug 4.

Results Reference

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PubMed Identifier

31390977

Citation

Spinelli E, Mauri T, Fogagnolo A, Scaramuzzo G, Rundo A, Grieco DL, Grasselli G, Volta CA, Spadaro S. Electrical impedance tomography in perioperative medicine: careful respiratory monitoring for tailored interventions. BMC Anesthesiol. 2019 Aug 7;19(1):140. doi: 10.1186/s12871-019-0814-7. Erratum In: BMC Anesthesiol. 2019 Sep 4;19(1):172.

Results Reference

background

PubMed Identifier

27687426

Citation

Bordes J, Goutorbe P, Cungi PJ, Boghossian MC, Kaiser E. Noninvasive ventilation during spontaneous breathing anesthesia: an observational study using electrical impedance tomography. J Clin Anesth. 2016 Nov;34:420-6. doi: 10.1016/j.jclinane.2016.04.016. Epub 2016 Jun 16.

Results Reference

background

PubMed Identifier

21395895

Citation

Humphreys S, Pham TM, Stocker C, Schibler A. The effect of induction of anesthesia and intubation on end-expiratory lung level and regional ventilation distribution in cardiac children. Paediatr Anaesth. 2011 Aug;21(8):887-93. doi: 10.1111/j.1460-9592.2011.03547.x. Epub 2011 Mar 14.

Results Reference

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Effects of NIV and CPAP on Ventilation Distribution, Measured by EIT, During Deep Sedation in Paediatric Patients

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