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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT06151886
Other study ID # J-23039527
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date September 18, 2023
Est. completion date December 1, 2023

Study information

Verified date November 2023
Source Rigshospitalet, Denmark
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

In Denmark, life-dependent home-mechanical ventilation (HMV) is given under the surveillance of a specifically trained respiratory patient caregiver (tPCG). The HMV can be invasive through a tracheostomy or non-invasive via a mask. The purpose of this study is to uncover experiences and challenges associated with having a trained respiratory patient care giver (tPCG) to surveil home-mechanical ventilation (HMV) from the perspective of the patients and their families and to gather information about the expirence of working in a home as a tPCG


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 200
Est. completion date December 1, 2023
Est. primary completion date December 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: Patient Age > 18 years Has trained patient care givers to surveil the respiratory treatment and working on the responsibility of the Respiratory Center East Parent Age > 18 years Has a child less than 18 years old with tPCG, working on the responsibility of the Respiratory Center East, to surveil the home-mechanical ventilation Other relative: Age > 18 years Involved in the treatment or support of a relative with tPCG, working on the responsibility of the Respiratory Center East, to surveil the home-mechanical ventilation Trained patient caregivers (tPCG) Age > 18 years Employed by an external agency or by the patient (BPA) to surveil home-mechanical ventilation Certified as tPCG working on the responsibility of the Respiratory Center East Exclusion Criteria: - No informed consent to participate

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Denmark Department of Anaesthesia, Pain and REspiratory Support GLostrup

Sponsors (1)

Lead Sponsor Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Severe respiratory insufficiency questionnaire The patients will be asked to fullfill the questionnaire Assessed within the last 7 days
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