Ventilator LungNCT06151886
Life-dependent Home Mechanical Ventilation
An observational study of Ventilator Lung, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ventilator Lung
- How many people
- 126 participants
- Where
- 1 siteDenmark
- Study dates
- 18 Sep 2023to 1 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- No informed consent to participate
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Anaesthesia, Pain and REspiratory Support
Glostrup Municipality, 2600
About this study
Official title: 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
- Conditions
- Ventilator Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Not described | |
| Relatives | Not described | |
| Trained respiratory patient caregiver | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severe respiratory insufficiency questionnaire
The patients will be asked to fullfill the questionnaire
Measured: Assessed within the last 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2023
- Study start18 Sep 2023
- Primary completion1 Dec 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventilator LungStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anne Kathrine Staehr-Rye, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06151886
- Sponsor's protocol ID
- J-23039527
- Status last verified
- May 2026
- First submitted
- 6 Sep 2023
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Experiences and Challenges in Life-dependent Home Mechanical Ventilation - a Part of the Air For Life Project
- ClinicalTrials.gov ID
- NCT06151886
- Acronym / sponsor ID
- J-23039527
- Conditions
- Ventilator Lung
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 18 Sep 2023 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 30 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients | – | – |
| Relatives | – | – |
| Trained respiratory patient caregiver | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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
- 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
Key exclusion criteria (1 listed)
- No informed consent to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Severe respiratory insufficiency questionnaire
Time frame: Assessed within the last 7 days
The patients will be asked to fullfill the questionnaire
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
- Individual participant dataSharing planned: Undecided
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Not yet recruitingObservational study
Early Identification of Pathogens in Children With Respiratory Tract Infection by Mechanical Ventilation Using mNGS
VAP - Ventilator Associated Pneumonia
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ventilator Lung, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severe respiratory insufficiency questionnaire (time frame: Assessed within the last 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2026.