Prospective, Open, Non-interventional Study to Assess the Ability of an Electrical Impedance Tomograph (PlumoVista 500) (PV500ped)

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.

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).

Study Overview

• Status: Completed
• Conditions: Monitoring of Regional Distribution of Ventilation; Monitoring of Lung Volume

• Study Type: Observational
• Enrollment (Actual): 23

Contacts and Locations

Study Locations

• Germany
  • Traunstein, Germany, 83278
    • Klinik für Kinder- und Jugendmedizin Klinikum Traunstein

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 11 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
assess the capability of PulmoVista 500 for continuous monitoring of ventilation	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.	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.

Collaborators and Investigators

• Sponsor: Drägerwerk AG & Co. KGaA
• Investigators: Principal Investigator: Gerhard Wolf, PD Dr., Children's hospital Traunstein

Study record dates

Study Major Dates

• Study Start (Actual): May 3, 2021
• Primary Completion (Actual): July 28, 2021
• Study Completion (Actual): July 28, 2021

Study Registration Dates

• First Submitted: April 30, 2021
• First Submitted That Met QC Criteria: April 30, 2021
• First Posted (Actual): May 5, 2021

Study Record Updates

• Last Update Posted (Actual): March 29, 2022
• Last Update Submitted That Met QC Criteria: March 28, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: PV500ped

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No