Post-hoc Analysis of Regional Pulmonary Perfusion and Hem... | NCT04249414

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

NCT04249414

Sponsor

Drägerwerk AG & Co. KGaA

Status

Suspended

Last Update Posted

Mar 6, 2023Actual

Enrollment

22Estimated

Phase

Not provided

Conditions

Mechanical Ventilation
Ventilation Perfusion Mismatch

Interventions

PulmoVista 500

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2023

Overall Recruitment Status or Expanded Access Status

Suspended

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Due to a lack of resources (human and financial), it is currently unclear if the study will be counducted.

Expanded Access Info

Start Date

Jan 2024Estimated

Primary Completion Date

Jun 2024Estimated

Completion Date

Dec 2024Estimated

First Submitted Date

Jan 27, 2020

First Submission Date that Met QC Criteria

Jan 29, 2020

First Posted Date

Jan 31, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 3, 2023

Last Update Posted Date

Mar 6, 2023Actual

Name	Class
University of Göttingen	OTHER
Prof. Dr. med. Imhoff	UNKNOWN

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

22Estimated

Name	Type	Description	Arm Group Labels	Other Names
PulmoVista 500	Device	Monitoring of Ventilation and Perfusion with the PulmoVista 500 during clinical routine. No medical interventions required

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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
Assess hemodynamic parameter heart rate

Other Outcomes

Not provided

Eligibility Module

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
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