Life-dependent Home Mechanical Ventilation

Ventilator Lung Clinical Trial

Official title:

Experiences and Challenges in Life-dependent Home Mechanical Ventilation - a Part of the Air For Life Project

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06151886
• Other study ID #: J-23039527
• Status: Enrolling by invitation
• 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
• 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

Related Conditions & MeSH terms

• Ventilator Lung

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