Effects of NIV and CPAP on Ventilation Distribution, Measured by EIT, During Deep Sedation in Paediatric Patients
NCT ID: NCT05495477
Last Updated: 2022-08-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
20 participants
INTERVENTIONAL
2021-04-20
2024-10-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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Spontaneous breathing
Electrical impedance tomography (EIT).
EIT
Evaluation of ventilation distrinution during deep sedation through EIT
CPAP mode
Electrical impedance tomography (EIT).
EIT
Evaluation of ventilation distrinution during deep sedation through EIT
NIV- S/T mode
Electrical impedance tomography (EIT).
EIT
Evaluation of ventilation distrinution during deep sedation through EIT
Interventions
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EIT
Evaluation of ventilation distrinution during deep sedation through EIT
Eligibility Criteria
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Inclusion Criteria
* ASA score ≤ 2
* Sedation time ≥ 30 min
Exclusion Criteria
* 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)
1 Year
10 Years
ALL
No
Sponsors
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Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
OTHER
Responsible Party
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Principal Investigators
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Giovanna Chidini
Role: PRINCIPAL_INVESTIGATOR
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Locations
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Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico Milano
Milan, , Italy
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
Other Identifiers
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2021/2178
Identifier Type: -
Identifier Source: org_study_id
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