Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2025-12-24 @ 7:58 PM
NCT ID:
NCT05405504
Eligibility Criteria:
Inclusion Criteria:
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 Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05405504
Study Brief:
Protocol Section:
NCT05405504