Improving respiratory monitoring by directly capturing the electrical activity of the diaphragm

Improving respiratory monitoring by directly capturing the electrical activity of the diaphragm - Explorative study for algorithm testing JBZ

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON49239

Enrollment

Registered

2020-05-29

Start date

2020-06-16

Completion date

Unknown

Last updated

2025-09-08

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

Conditions

Monitoring van ademhalingsfrequentie (en hartfrequentie) in neonaten Cardio-respiratory status premature infants

Interventions

None listed

Eligibility

Age

2 Years to 11 Years

Inclusion criteria

Inclusion criteria: Gestational age 26 - 42 weeks Written parental informed consent

Exclusion criteria

Exclusion criteria: -Patients requiring defibrillation. The device should be removed prior to start of defibrillation -Patients with implanted electronic devices of any kind, including cardiac pace-makers or similar assistive devices, electronic infusion pumps and implanted stimulators -Patients with irritated skin or open wounds or with allergies to Silver . In case skin irritation or discomfort occurs, use of device must be discontinued. -Patients requiring diagnostic imaging (X-thorax, MRI, cardiac ultrasonography) during the study -Unsuitability for an informed consent conversation; e.g. timewise or attention-wise too much of a burden for parents -Patients with parents who do not speak and/or read the native language or English

Design outcomes

Primary

Measure	Time frame
To collect sufficient reference data of dEMG in neonates, in a representative population and for specific routine caregiving scenarios, to use for testing and optimizaton of the Bambi Belt B.V. algorithm.	—

Countries

Netherlands

Outcome results