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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05495477
Acronym
NIVEIT-ped
Enrollment
20
Registered
2022-08-10
Start date
2021-04-20
Completion date
2024-10-30
Last updated
2022-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mechanical Ventilation Complication, Respiratory Failure, Sedation

Keywords

NIV; CPAP; EIT;

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.

Interventions

DEVICEEIT

Evaluation of ventilation distrinution during deep sedation through EIT

Sponsors

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
1 Years to 10 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Regional Ventilation Delay (pixels %), RDV1 dayIt's an index of atelectrauma, supra-distension and in general an inhomogeneous ventilation

Secondary

MeasureTime frame
Inhomogeneity Index (pixels), GI1 day
Gravity Centre(pixels %), GC1 day

Countries

Italy

Contacts

Primary ContactGiovanna Chidini, MD
giovanna.chidini@policlinico.mi.it0255032242
Backup ContactStefano Scalia Catenacci, MD
stefano.scaliacatenacci@policlinico.mi.it0255032242

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026