Status:
UNKNOWN
Evaluation of ReDS Pro System V2.7 and ReDS ICU in Patients With Heart Failure
Lead Sponsor:
Christian Hassager
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Brief Summary
The study is an investigator-initiated, prospective cohort trial. The trial aims to evaluate ReDS Pro System V2.7 and ReDS ICU in patients with heart failure (HF).
Detailed Description
The study is an investigator-initiated, prospective cohort trial. The trial aims to evaluate ReDS Pro System V2.7 and ReDS ICU in patients with heart failure (HF). The overall purposes are: * to eval...
Eligibility Criteria
Inclusion
- ICU part:
- at least 18 years of age
- hospitalized in ICU setting at Rigshospitalet
- intubated
- unconscious or sedated (Glasgow Coma Score \<8)
- monitored using Swan-Ganz and arterial catherization.
- Out-patient part:
- at least 18 years of age
- history of Chronic heart failure \> 3 months
- CardioMEMS
Exclusion
- ICU part:
- pacemaker or ICD on the right side
- congenital heart malformations or intra-thoracic mass that would affect the right lung anatomy (e.g. dextrocardia, lung carcinoma)
- wounds, burns, healing tissue, skin infection or recent skin graft or flap where the sensors should be attached to the skin
- habitus is out of range due to one or more of the following
- height less than 155 cm or higher than 195 cm
- estimated BMI of less than 22 or more than 36
- standard active therapy has been stopped as the patient is inevitably dying.
- Out-patient part:
- pacemaker or ICD on the right side
- congenital heart malformations or intra-thoracic mass that would affect the right lung anatomy (e.g. dextrocardia, lung carcinoma)
- wounds, burns, healing tissue, skin infection or recent skin graft or flap where the sensors should be attached to the skin
- habitus is out of range due to one or more of the following Height less than 155 cm or higher than 195 cm BMI of less than 22 or more than 38 For BMI 36 to 38, chest size ruler should be 39 or less
- cancer or other severe non-cardiac disease with estimated life expectancy less than 1 year
- planned hospitalization for ICD, pacemaker, lung or heart surgery including heart transplantation during the study period.
Key Trial Info
Start Date :
June 13 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 1 2024
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT05405504
Start Date
June 13 2022
End Date
February 1 2024
Last Update
June 14 2022
Active Locations (1)
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1
Rigshospitalet
Copenhagen, Denmark, 2100