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

NCT04249414 | Suspended

• 1 other identifier: PV500PERF
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Mechanical Ventilation; Ventilation Perfusion Mismatch

Keywords

Ventilation Monitoring; Electrical Impedance Tomography; Perfusion Monitoring; Hemodynamic Monitoring

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Assess hemodynamic parameter cardiac output

  within 24 hours

• Assess hemodynamic parameter heart rate

  within 24 hours

• Assess hemodynamic parameter stroke volume variability

  within 24 hours

• Assess oxygenation status

  within 24 hours

Interventions

PulmoVista 500 DEVICE

Monitoring of Ventilation and Perfusion with the PulmoVista 500 during clinical routine. No medical interventions required

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Drägerwerk AG & Co. KGaA: lead
• University of Göttingen: collaborator
• Prof. Dr. med. Imhoff: collaborator

Study Sites (1)

University Medical Center Göttingen

Göttingen, 37075, Germany

Location

Study Officials

• Onnen Mörer, Prof. Dr.

  Centre of Anaesthesiology University Medical Center Göttingen

  PRINCIPAL INVESTIGATOR

• Michael Quintel, Prof. Dr.

  Centre of Anaesthesiology University Medical Center Göttingen

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: January 27, 2020
• First Posted: January 31, 2020
• Study Start: January 1, 2024
• Primary Completion: June 1, 2024
• Study Completion: December 1, 2024
• Last Updated: March 6, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)