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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Total Enrollment

22 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-31

Study Completion Date

2024-12-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Mechanical Ventilation Ventilation Perfusion Mismatch

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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PulmoVista 500

Monitoring of Ventilation and Perfusion with the PulmoVista 500 during clinical routine.

No medical interventions required

Intervention Type DEVICE

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No