NIVEIT-ped: Effects of NIV and CPAP on Ventilation Distribution, Measured by EIT, During Deep Sedation in Paediatric Patients
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Spontaneous breathing Electrical impedance tomography (EIT). |
Device: EIT
Evaluation of ventilation distrinution during deep sedation through EIT
|
| Active Comparator: CPAP mode Electrical impedance tomography (EIT). |
Device: EIT
Evaluation of ventilation distrinution during deep sedation through EIT
|
| Active Comparator: NIV- S/T mode Electrical impedance tomography (EIT). |
Device: EIT
Evaluation of ventilation distrinution during deep sedation through EIT
|
Outcome Measures
Primary Outcome Measures
- Regional Ventilation Delay (pixels %), RDV [1 day]
It's an index of atelectrauma, supra-distension and in general an inhomogeneous ventilation
Secondary Outcome Measures
- Inhomogeneity Index (pixels), GI [1 day]
- Gravity Centre(pixels %), GC [1 day]
Eligibility Criteria
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
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Severe obesity
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Dorso-lumbar pathologies or other bone pathologies associated with restrictive lung disease (such as scoliosis, kyphosis)
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Neuromuscular, mitochondrial, metabolic or chromosomal disease with hypotonia
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CPAP or NIV treatment at home
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Hand-Bag Ventilation (HBV) during the procedure (loss of the respiratory drive)
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Non-Total IntraVenous Anaesthesia (TIVA), adherence to the sedation protocol
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Implantable devices not compatible with EIT (such as pace-makers and implantable cardioverter defibrillator)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico Milano | Milan | Italy | 20122 |
Sponsors and Collaborators
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Investigators
- Principal Investigator: Giovanna Chidini, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Milano
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- 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.
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