Clinical trial NCT05495477: Effects of NIV and CPAP on Ventilation Distribution, Measured by EIT, During Deep Sedation in Paediatric Patients
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
Overall status: UNKNOWN
Phase: NA
Conditions: Respiratory Failure
Sedation
Mechanical Ventilation Complication
Keywords: NIV; CPAP; EIT;
Lead sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Sponsor class: OTHER
First posted: 2022-08-10
Enrollment: 20
Sex: ALL
Minimum age (years): 1
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Regional Ventilation Delay (pixels %), RDV
timeFrame: 1 day
Secondary outcomes:
measure: Inhomogeneity Index (pixels), GI
timeFrame: 1 day
measure: Gravity Centre(pixels %), GC
timeFrame: 1 day
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico Milano
Study officials:
affiliation: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
name: Giovanna Chidini
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.