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

Sponsor

Drägerwerk AG & Co. KGaA (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT04249414

Collaborator

University of Göttingen (Other), Prof. Dr. med. Imhoff (Other)

Enrollment

Location

6.5

Anticipated Duration (Months)

3.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Mechanical Ventilation Ventilation Perfusion Mismatch	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 Design

Study Type:

Observational

Anticipated Enrollment :

22 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Jun 15, 2022

Anticipated Primary Completion Date :

Dec 15, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Outcome Measures

Primary Outcome Measures

Assess regional distribution of pulmonary perfusion [within 24 hours]
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.

Secondary Outcome Measures

Assess hemodynamic parameter cardiac output [within 24 hours]
The capability of PulmoVista® 500 for assessing cardiac output (relative values compared to reference given in l/min) will be explored.
Assess hemodynamic parameter heart rate [within 24 hours]
The capability of PulmoVista® 500 for assessing heart rate (1/min) will be explored.
Assess hemodynamic parameter stroke volume variability [within 24 hours]
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.
Assess oxygenation status [within 24 hours]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Medical Center Göttingen	Göttingen		Germany	37075

Sponsors and Collaborators

Drägerwerk AG & Co. KGaA
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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Drägerwerk AG & Co. KGaA

ClinicalTrials.gov Identifier:

NCT04249414

Other Study ID Numbers:

PV500PERF

First Posted:

Jan 31, 2020

Last Update Posted:

Mar 29, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Drägerwerk AG & Co. KGaA

Ventilation Monitoring

Electrical Impedance Tomography

Perfusion Monitoring

Hemodynamic Monitoring

Study Results

No Results Posted as of Mar 29, 2022