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

Mechanical Ventilation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04249414
• Other study ID #: PV500PERF
• Status: Suspended
• Start date: January 2024
• Est. completion date: December 2024

Study information

• Verified date: March 2023
• Source: Drägerwerk AG & Co. KGaA
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 22
• Est. completion date: December 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Mechanical Ventilation
• Ventilation Perfusion Mismatch

Intervention

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

Locations

Country	Name	City	State
Germany	University Medical Center Göttingen	Göttingen

Sponsors (3)

Lead Sponsor	Collaborator
Drägerwerk AG & Co. KGaA	Prof. Dr. med. Imhoff, University of Göttingen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Assess hemodynamic parameter heart rate	The capability of PulmoVista® 500 for assessing heart rate (1/min) will be explored.	within 24 hours
Secondary	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
Secondary	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