Clinical trial NCT04873999: Prospective, Open, Non-interventional Study to Assess the Ability of an Electrical Impedance Tomograph (PlumoVista 500)
Official title: 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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Monitoring of Regional Distribution of Ventilation
Monitoring of Lung Volume
Lead sponsor: Drägerwerk AG & Co. KGaA
Sponsor class: INDUSTRY
First posted: 2021-05-05
Enrollment: 23
Sex: ALL
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric patients that visit the hospital for any kind of surgery, therefore requireing mechanical ventilation. Monitoring of Regional Distribution of Ventilation and Lung Volume are of clinical interest in these patients.

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).


Eligibility criteria: 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

Primary outcomes:
measure: assess the capability of PulmoVista 500 for continuous monitoring of ventilation
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Traunstein
country: Germany
facility: Klinik für Kinder- und Jugendmedizin Klinikum Traunstein
Study officials:
affiliation: Children's hospital Traunstein
name: Gerhard Wolf, PD Dr.
role: PRINCIPAL_INVESTIGATOR
References: