Life-dependent Home Mechanical Ventilation

May 6, 2026 updated by: Anne Kathrine Staehr-Rye, Rigshospitalet, Denmark

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

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

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

126

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Glostrup Municipality, Denmark, 2600
        • Department of Anaesthesia, Pain and REspiratory Support

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

All patients assigned with a trained patient care giver to surveil the respiratory treatment (invasive and noninvasive mechanical ventilation) and working on the responsibility of the Respiratory Center East, their relatives as well as trained respiratory patient caregivers working on the responsibility of the Respiratory Center East

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Patients
Relatives
Trained respiratory patient caregiver

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Severe respiratory insufficiency questionnaire
Time Frame: Assessed within the last 7 days
The patients will be asked to fullfill the questionnaire
Assessed within the last 7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 18, 2023

Primary Completion (Actual)

December 1, 2023

Study Completion (Actual)

December 1, 2023

Study Registration Dates

First Submitted

September 6, 2023

First Submitted That Met QC Criteria

November 21, 2023

First Posted (Actual)

November 30, 2023

Study Record Updates

Last Update Posted (Actual)

May 11, 2026

Last Update Submitted That Met QC Criteria

May 6, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • J-23039527

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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