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

Respiratory Failure Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05495477
• Other study ID #: 2021/2178
• Status: Recruiting
• Phase: N/A
• Start date: April 20, 2021
• Est. completion date: October 30, 2024

Study information

• Verified date: February 2022
• Source: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
• Contact: Giovanna Chidini, MD
• Phone: 0255032242
• Email: giovanna.chidini[@]policlinico.mi.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: October 30, 2024
• Est. primary completion date: June 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 10 Years

Eligibility

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)

Related Conditions & MeSH terms

• Mechanical Ventilation Complication
• Respiratory Failure
• Respiratory Insufficiency
• Sedation

Intervention

Device:
• EIT
Evaluation of ventilation distrinution during deep sedation through EIT

Locations

Country	Name	City	State
Italy	Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico Milano	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Country where clinical trial is conducted

Italy, 

References & Publications (5)

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. — View 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. — View 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. Review. — View 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. Review. Erratum in: BMC Anesthesiol. 2019 Sep 4;19(1):172. — View Citation

Zhao Z, Möller 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Regional Ventilation Delay (pixels %), RDV	It's an index of atelectrauma, supra-distension and in general an inhomogeneous ventilation	1 day
Secondary	Inhomogeneity Index (pixels), GI		1 day
Secondary	Gravity Centre(pixels %), GC		1 day