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Life-dependent Home Mechanical Ventilation

Sponsor
Rigshospitalet, Denmark (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT06151886
Collaborator
(none)
200
Enrollment
1
Location
2.4
Anticipated Duration (Months)
82.3
Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    200 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Experiences and Challenges in Life-dependent Home Mechanical Ventilation - a Part of the Air For Life Project
    Actual Study Start Date :
    Sep 18, 2023
    Anticipated Primary Completion Date :
    Dec 1, 2023
    Anticipated Study Completion Date :
    Dec 1, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    Patients
    Relatives
    Trained respiratory patient caregiver

    Outcome Measures

    Primary Outcome Measures

    1. Severe respiratory insufficiency questionnaire [Assessed within the last 7 days]

      The patients will be asked to fullfill the questionnaire

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Anaesthesia, Pain and REspiratory Support GLostrup Denmark 2600

    Sponsors and Collaborators

    • Rigshospitalet, Denmark

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Anne Kathrine Staehr-Rye, Principal investigator, clinical associate professor, Rigshospitalet, Denmark
    ClinicalTrials.gov Identifier:
    NCT06151886
    Other Study ID Numbers:
    • J-23039527
    First Posted:
    Nov 30, 2023
    Last Update Posted:
    Nov 30, 2023
    Last Verified:
    Nov 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Nov 30, 2023