Post-hoc Analysis of Regional Pulmonary Perfusion and Hemodynamic Parameters Measured by Electrical Impedance Tomography

Define the capability and reliability of the PulmoVista® 500 (PV500) to detect changes in global and regional ventilation and perfusion.

Study Overview

• Status: Suspended
• Conditions: Mechanical Ventilation; Ventilation Perfusion Mismatch
• Intervention / Treatment: Device: PulmoVista 500

Detailed Description

The results of this study will help defining the capability and reliability of PulmoVista® 500 (PV500) to detect changes in both global and regional ventilation and perfusion. As this is a non-invasive, observational trial, neither a positive nor a negative impact on the actual study participants is expected. The results will, however, improve the knowledge about the electrical impedance tomography (EIT) technology and thus aid the use of this technology for the benefit of future patients.

• Study Type: Observational
• Enrollment (Anticipated): 22

Contacts and Locations

• Study Contact: Name: Birgit Stender; Phone Number: 6448 +49451882; Email: birgit.stender@draeger.com
• Study Contact Backup: Name: Ulla Schöning, M.Sc.; Phone Number: 5612 +49451882; Email: ClinicalAffairs@draeger.com

Study Locations

• Germany
  • Göttingen, Germany, 37075
    • University Medical Center Göttingen
    • Contact: Onnen Mörer, Prof. Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients in the ICU who are mandatorily ventilated for at least 48 hours.

Description

Inclusion Criteria:

• Age 18 - 80 years
• Mandatorily ventilated intensive-care patients with impairment in oxygenation (P/F ratio < 300 at PEEP ≥ 5) ventilated at a positive end-expiratory pressure (PEEP) not exceeding 10 mbar and an fraction of inspired oxygen (FiO2) chosen, such that pulse oximetry is sensitive towards arterial oxygen pressure (PaO2) changes.
• Expected ventilation time >48h
• Existing central venous and arterial access
• Chest circumference 70 - 150 cm
• Mandatory mechanical ventilation (patients without spontaneous efforts)
• Serum levels of sodium and chloride within normal range
• Cardiac output monitoring in place (PICCO)

Exclusion Criteria:

• Contraindication to central venous injection of 5 % sodium chloride (NaCl) (e.g. elevated Na+ and/or Cl- concentration: Na+ should not exceed 150 mmol/l, Chloride should not exceed 115 mmol/l, known hypernatremia, known high serum osmolality)

• Contraindications of PulmoVista 500:

  • Patients with pacemakers, defibrillators or other electrically active implants
  • Patients with damaged skin or impaired skin contact of the electrodes due to wound dressings
  • Patients where the attachment of the patient belt could pose a risk to the patient, e.g. patients with spinal lesions or fractures
  • Patients with uncontrolled body movements
  • Extremely obese patients (BMI>50)
  • Patients during pregnancy
  • Patients with massive lung edema
  • Use during electricity-based therapies, such as electrosurgery or electrocautery
  • Use in the presence of strong magnetic fields
  • Use in conjunction with other bioimpedance measurement devices
• Infection or colonization with multi-resistant pathogens that require isolation of the patient (e.g. MRSA)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess regional distribution of pulmonary perfusion	The capability of PulmoVista® 500 for assessing regional distribution of pulmonary perfusion based on pulsatility signals and based on indicator dilution and changes at different points in time during varying states of regional ventilation will be evaluated.	within 24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess hemodynamic parameter cardiac output	The capability of PulmoVista® 500 for assessing cardiac output (relative values compared to reference given in l/min) will be explored.	within 24 hours
Assess hemodynamic parameter heart rate	The capability of PulmoVista® 500 for assessing heart rate (1/min) will be explored.	within 24 hours
Assess hemodynamic parameter stroke volume variability	The capability of PulmoVista® 500 for assessing stroke volume variability (relative value in % for 30 seconds compared to reference given in ml) will be explored.	within 24 hours
Assess oxygenation status	The capability PulmoVista® 500 for assessing the oxygenation status from both the regional distribution of alveolar ventilation and the regional distribution of pulmonary perfusion will be explored.	within 24 hours

Collaborators and Investigators

• Sponsor: Drägerwerk AG & Co. KGaA
• Collaborators: University of Göttingen; Prof. Dr. med. Imhoff
• Investigators: Principal Investigator: Onnen Mörer, Prof. Dr., Centre of Anaesthesiology University Medical Center Göttingen; Study Director: Michael Quintel, Prof. Dr., Centre of Anaesthesiology University Medical Center Göttingen

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2024
• Primary Completion (Anticipated): June 1, 2024
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: January 27, 2020
• First Submitted That Met QC Criteria: January 29, 2020
• First Posted (Actual): January 31, 2020

Study Record Updates

• Last Update Posted (Estimate): March 6, 2023
• Last Update Submitted That Met QC Criteria: March 3, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Electrical Impedance Tomography; Ventilation Monitoring; Perfusion Monitoring; Hemodynamic Monitoring
• Other Study ID Numbers: PV500PERF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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