Clinical trial NCT04249414: Post-hoc Analysis of Regional Pulmonary Perfusion and Hemodynamic Parameters Measured by Electrical Impedance Tomography
Official title: Post-hoc Analysis of Regional Pulmonary Perfusion and Hemodynamic Parameters Measured by Electrical Impedance Tomography
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Mechanical Ventilation
Ventilation Perfusion Mismatch
Keywords: Ventilation Monitoring
Electrical Impedance Tomography
Perfusion Monitoring
Hemodynamic Monitoring
Lead sponsor: Drägerwerk AG & Co. KGaA
Sponsor class: INDUSTRY
Collaborators: name: University of Göttingen
name: Prof. Dr. med. Imhoff
First posted: 2020-01-31
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients in the ICU who are mandatorily ventilated for at least 48 hours.

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

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Assess regional distribution of pulmonary perfusion
timeFrame: within 24 hours
Secondary outcomes:
measure: Assess hemodynamic parameter cardiac output
timeFrame: within 24 hours
measure: Assess hemodynamic parameter heart rate
timeFrame: within 24 hours
measure: Assess hemodynamic parameter stroke volume variability
timeFrame: within 24 hours
measure: Assess oxygenation status
timeFrame: within 24 hours
Other outcomes:
Locations:
city: Göttingen
country: Germany
facility: University Medical Center Göttingen
Study officials:
affiliation: Centre of Anaesthesiology University Medical Center Göttingen
name: Onnen Mörer, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre of Anaesthesiology University Medical Center Göttingen
name: Michael Quintel, Prof. Dr.
role: STUDY_DIRECTOR
References: