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

NCT04873999 | Completed

• 1 other identifier: PV500ped
• Study Type: observational
• Target: 23
• Locations: 1 country
• Sites: 1

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).

Conditions

Monitoring of Regional Distribution of Ventilation; Monitoring of Lung Volume

Outcome Measures

Primary Outcomes (1)

• 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.

Eligibility Criteria

• Age: Up to 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• Pediatric male or female patients excluding preterm infants
• Patients with a chest circumference between 36 and 72 cm
• Patients ≤ 12 years.
• 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)
• Patients for whom mechanical ventilation is intended
• Patients whose regional distribution of ventilation and of lung volume are of clinical interest
• Patients who are (should be) ventilated via an artificial airway access, whereby the ventilator used is compatible with PulmoVista 500
• Patients and / or their legal guardians or legal representatives who have given written informed consent to participate in the study

You may not qualify if:

• 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)
• Patients with a tidal volume ≤ 20 ml
• Patients in whom the application of the electrode belt could be impaired by wound care or infections in the chest area
• Female patients for whom pregnancy cannot be excluded; a pregnancy test should be performed at the discretion of the investigator.
• Patients with an alleged allergic reaction to the materials of the electrode belt
• Patients with a Body Mass Index (BMI) \> 40
• Evidence that suggests that the patient or their legal representative will not comply with the protocol requirements
• Patients with a proven infectious disease (e.g. SARS-COV-19, MRSA) that requires isolation of the patient

Sponsors & Collaborators

• Drägerwerk AG & Co. KGaA: lead

Study Sites (1)

Klinik für Kinder- und Jugendmedizin Klinikum Traunstein

Traunstein, 83278, Germany

Location

Related Publications (1)

• Clasen D, Winter I, Rietzler S, Wolf GK. Changes in ventilation distribution during general anesthesia measured with EIT in mechanically ventilated small children. BMC Anesthesiol. 2023 Apr 12;23(1):118. doi: 10.1186/s12871-023-02079-z.

  PMID: 37046213 DERIVED

Study Officials

• Gerhard Wolf, PD Dr.

  Children's hospital Traunstein

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2021
• First Posted: May 5, 2021
• Study Start: May 3, 2021
• Primary Completion: July 28, 2021
• Study Completion: July 28, 2021
• Last Updated: March 29, 2022

Record last verified: 2022-03

Locations

DE (1)