Prospective, Open, Non-interventional Study to Assess the Ability of an Electrical Impedance Tomograph (PlumoVista 500)

Prospective, Open, Non-interventional Study to Assess the Ability of an Electrical Impedance Tomograph (PlumoVista 500) to Monitor Changes in Lung Ventilation Over Time in Mechanically Ventilated Children.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04873999

Acronym

PV500ped

Enrollment

Registered

2021-05-05

Start date

2021-05-03

Completion date

2021-07-28

Last updated

2022-03-29

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

Conditions

Monitoring of Lung Volume, Monitoring of Regional Distribution of Ventilation

Brief summary

This observational PMCF study will be conducted to generate and gather clinical data from the intended target population of pediatric patients. The intention for Post-Market Clinical Follow-up (PMCF) is to confirm the performance and safety of a device throughout the device's lifecycle. PulmoVista 500 is a lung function monitor for clinical use which continuously generates cross-sectional images of the lung function by applying the technique of electrical impedance tomography (EIT).

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

No minimum to 11 Years

Healthy volunteers

Yes

Inclusion criteria

1. Pediatric male or female patients excluding preterm infants 2. Patients with a chest circumference between 36 and 72 cm 3. Patients ≤ 12 years. 4. Patients with a tidal volume \> 20 ml, i.e., children with a body weight of more than 3.3 kg (assuming a targeted tidal volume of 6 mL/kg body weight) 5. Patients for whom mechanical ventilation is intended 6. Patients whose regional distribution of ventilation and of lung volume are of clinical interest 7. Patients who are (should be) ventilated via an artificial airway access, whereby the ventilator used is compatible with PulmoVista 500 8. Patients and / or their legal guardians or legal representatives who have given written informed consent to participate in the study

Exclusion criteria

1. Patients who are supplied with a permanent or temporary pacemaker, an implantable defibrillator or other medical devices that emit electrical energy (e.g. cochlea amplifier implant) 2. Patients with a tidal volume ≤ 20 ml 3. Patients in whom the application of the electrode belt could be impaired by wound care or infections in the chest area 4. Female patients for whom pregnancy cannot be excluded; a pregnancy test should be performed at the discretion of the investigator. 5. Patients with an alleged allergic reaction to the materials of the electrode belt 6. Patients with a Body Mass Index (BMI) \> 40 7. Evidence that suggests that the patient or their legal representative will not comply with the protocol requirements 8. Patients with a proven infectious disease (e.g. SARS-COV-19, MRSA) that requires isolation of the patient

Design outcomes

Primary

Measure	Time frame	Description
assess the capability of PulmoVista 500 for continuous monitoring of ventilation	Duration per participant: 2 - 3 days (screening, procedure with PulmoVista 500, safety follow-up). Measurements with PulmoVista 500 per patient during mechanical ventilation is anticipated for a maximum of 10 minutes in total.	To assess the capability of PulmoVista 500 for continuous monitoring of ventilation, the cross-correlation function (CCF) between the global impedance waveform of EIT and global tidal volume waveforms of a ventilator across multiple respiratory cycles in patients under controlled mechanical ventilation, will be evaluated.

Countries

Germany

Outcome results