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Air-volume measurement during newborns respiration while breathing calmly using electrical impedance tomography

Evaluation of tidal volume in spontaneous ventilation by electric impedance tomography in eupneic newborns

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
REBEC
Registry ID
RBR-6q3w5k7
Enrollment
Unknown
Registered
2021-12-01
Start date
2020-08-01
Completion date
Unknown
Last updated
2025-10-27

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

Conditions

Infant, Newborn

Interventions

50 newborn individuals will be monitored for the measurement of the volume entering and leaving the lungs using two different equipment. The first is Electrical Impedance Tomography (Enlight 1800, Tim

Sponsors

Faculdade de Medicina de Ribeirão Preto - Universidade de São Paulo
Lead Sponsor
Timpel S.A
Collaborator

Eligibility

Age
32 Weeks to 2 Months

Inclusion criteria

Inclusion criteria: Newborns with 32 weeks of corrected gestational age at the moment of the data acquisition; without the need of ventilatory support; the ones considered eupneic at the moment of the data acquisition

Exclusion criteria

Exclusion criteria: Newborns with cardiac pacemaker or other electronic implantable device; newborns with skin lesions in the area where the electrical impedance tomography belt will be placed; newborns with genetic syndromes or important cardiac malformations; newborns who could not be calmed and became too agitated during the assessments; newborns who had been previously mechanically ventilated or with history of pulmonary compromise

Design outcomes

Primary

MeasureTime frame
It is expected to find similar values ??between the volume of air entering and leaving the lungs (tidal volume) obtained by the two devices. This will be seen by comparing the tidal volume values ??obtained based on the electrical impedance tomography (which after the calculations will give a value in milliliters) against the tidal volume obtained using a flow sensor (ml) Both at the same moment in time of evaluation.

Secondary

MeasureTime frame
It is expected to find similar values ??between the volume of air entering and leaving the lungs (tidal volume) obtained by the two devices, but the values ??of the electrical impedance tomography will be mathematically modified to correct differences that may exist between the children. This will be seen by comparing the tidal volume values ??obtained based on the corrected electrical impedance tomography (which after the calculations will give a value in milliliters) against the tidal volume obtained using a flow sensor (ml) Both at the same time in the evaluation time.;It is expected to find differences in the tidal volume of newborns when comparing newborns from two groups, the first of those born by vaginal delivery, while the other group of those born by caesarean section.

Countries

Brazil

Contacts

Public ContactIsis Hoshino
isis.hoshino@unesp.br17981167659

Outcome results

None listed

Source: REBEC (via WHO ICTRP)