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

NCT05495477 | Unknown DMC

• 1 other identifier: 2021/2178
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Failure; Sedation; Mechanical Ventilation Complication

Keywords

NIV; CPAP; EIT;

Outcome Measures

Primary Outcomes (1)

• Regional Ventilation Delay (pixels %), RDV

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

  1 day

Secondary Outcomes (2)

• Inhomogeneity Index (pixels), GI

  1 day

• Gravity Centre(pixels %), GC

  1 day

Study Arms (3)

Spontaneous breathing

ACTIVE COMPARATOR

Electrical impedance tomography (EIT).

Device: EIT

CPAP mode

ACTIVE COMPARATOR

Electrical impedance tomography (EIT).

Device: EIT

NIV- S/T mode

ACTIVE COMPARATOR

Electrical impedance tomography (EIT).

Device: EIT

Interventions

EIT DEVICE

Evaluation of ventilation distrinution during deep sedation through EIT

CPAP mode; NIV- S/T mode; Spontaneous breathing

Eligibility Criteria

• Age: 1 Year - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico: lead

Study Sites (1)

Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico Milano

Milan, 20122, Italy

RECRUITING

Related Publications (6)

• 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.

  PMID: 22992946 BACKGROUND

• 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.

  PMID: 19652949 BACKGROUND

• 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.

  PMID: 31390977 BACKGROUND

• 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.

  PMID: 27687426 BACKGROUND

• 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.

  PMID: 21395895 BACKGROUND

• Chidini G, Marchesi T, Catenacci SS, Florio G, Conti G, Lanni S, Filocamo G, Patria F, Guerrini M, Milani G, Grasselli G. Effects of Noninvasive Respiratory Support on Ventilation Distribution During Spontaneous Breathing Sedation in Preschool/School-Aged Children: An Electrical Impedance Tomography Study. Paediatr Anaesth. 2025 Jul;35(7):562-572. doi: 10.1111/pan.15098. Epub 2025 Mar 22.

  PMID: 40119601 DERIVED

MeSH Terms

Conditions

Respiratory Insufficiency; Microcephaly, Primary Autosomal Recessive, 6

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Giovanna Chidini

  Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Giovanna Chidini, MD

CONTACT

0255032242; giovanna.chidini@policlinico.mi.it

Stefano Scalia Catenacci, MD

CONTACT

0255032242; stefano.scaliacatenacci@policlinico.mi.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2022
• First Posted: August 10, 2022
• Study Start: April 20, 2021
• Primary Completion: June 28, 2023
• Study Completion: October 30, 2024
• Last Updated: August 10, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)