Status:
COMPLETED
Prospective, Open, Non-interventional Study to Assess the Ability of an Electrical Impedance Tomograph (PlumoVista 500)
Lead Sponsor:
Drägerwerk AG & Co. KGaA
Conditions:
Monitoring of Regional Distribution of Ventilation
Monitoring of Lung Volume
Eligibility:
All Genders
Up to 11 years
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)...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
May 3 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 28 2021
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT04873999
Start Date
May 3 2021
End Date
July 28 2021
Last Update
March 29 2022
Active Locations (1)
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1
Klinik für Kinder- und Jugendmedizin Klinikum Traunstein
Traunstein, Germany, 83278