Chronic Hypercapnic Respiratory FailureNCT04872062
Monitoring of Patients With Chronic Respiratory Failure Treated With Non-invasive Home Ventilation: Contribution of New Monitoring Tools
An observational study of Chronic Hypercapnic Respiratory Failure, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
Single-center retrospective study conducted on a population of patients with chronic hypercapnic respiratory failure treated by non-invasive ventilation at home, followed at the CHRU of Nancy. The objective is to assess the contribution of reading the NIV card with a standardized grid in their follow-up. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Hypercapnic Respiratory Failure
- What is being tested?
- NIV cards and Medical file
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 1 Nov 2020to May 2021
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with chronic hypercapnic respiratory failure, treated with NIV at home, followed at the CHRU of Nancy in the UMA department between 11/01/2020 and 05/30/2021
Who may be able to join
- Major patients
- Patients with chronic hypercapnic respiratory failure with a validated indication of long-term NIV
- Follow-up at the CHRU of Nancy at "Unité de Médecine Ambulatoire" (UMA) department between 11/01/2020 and 05/30/2021
Who cannot join
- Data not usable / missing
- Tracheal ventilation
- Patients' opposition to the use of their data for the purposes of this research
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHRU de Nancy - Site de Brabois
Nancy, 54000
Julien Soler, +33647961454, soler.julien@yahoo.fr
About this study
Official title: Monitoring of Patients With Chronic Respiratory Failure Traeted With Non-invasive Home Ventilation: Contribution of New Monitoring Tools
Single-center retrospective study conducted on a population of patients with chronic hypercapnic respiratory failure treated by non-invasive ventilation at home, followed at the CHRU of Nancy. The objective is to assess the contribution of reading the NIV card with a standardized grid in their follow-up. The main objective is to assess the inter-observer agreement of a standardized NIV card reading grid, the secondary objective is to compare the results of NIV card reading between the usual NIV card reading method in the service and this same method completed by the addition of the standardized reading grid. The hypothesis is that the use of a standardized NIV card reading grid improves patient follow-up by standardizing their care.
- Conditions
- Chronic Hypercapnic Respiratory Failure
- Being tested
- NIV cards, Medical file
- Keywords
- chronic hypercapnic respiratory failure, non-invasive ventilation, standardized NIV reading grid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NIV cardsDevice
Reading the data available on the NIV cards
Medical fileOther
Using the data available in the medical file including clinical data, blood gas results, nocturnal oximetry results
| Study group | Role | What they receive |
|---|---|---|
| Chronic hypercapnic respiratory failure treated by home non-invasive ventilation (NIV) | Not described Receives: Device: NIV cards; Other: Medical file |
What is being measured
The primary outcome is the main question the study is designed to answer.
Agreement of responses to a standardized NIV reading grid between 2 observers
Measured: Day 0
Secondary outcomes (1)
Comparison of the results between two observers between the method of reading NIV card usually performed in the department and this same method supplemented with a standardized NIV reading grid
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2021
- Study start1 Nov 2020
- Primary completionMay 2021 (estimated)
- Study completionMay 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hypercapnic Respiratory FailureStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- Retrospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SOLER Julien, Central Hospital, Nancy, France
- Investigators
- Julien Soler, Study director, CentraHNF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04872062
- Sponsor's protocol ID
- 2020PI282
- Status last verified
- May 2021
- First submitted
- 21 Apr 2021
- Last updated
- 4 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring of Patients With Chronic Respiratory Failure Traeted With Non-invasive Home Ventilation: Contribution of New Monitoring Tools
- ClinicalTrials.gov ID
- NCT04872062
- Acronym / sponsor ID
- 2020PI282
- Conditions
- Chronic Hypercapnic Respiratory Failure
- Keywords
- chronic hypercapnic respiratory failure, non-invasive ventilation, standardized NIV reading grid
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- May 2021 (estimated)
- Study completion
- May 2021 (estimated)
- First posted
- 4 May 2021 (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.
Single-center retrospective study conducted on a population of patients with chronic hypercapnic respiratory failure treated by non-invasive ventilation at home, followed at the CHRU of Nancy. The objective is to assess the contribution of reading the NIV card with a standardized grid in their follow-up. The main objective is to assess the inter-observer agreement of a standardized NIV card reading grid, the secondary objective is to compare the results of NIV card reading between the usual NIV card reading method in the service and this same method completed by the addition of the standardized reading grid. The hypothesis is that the use of a standardized NIV card reading grid improves patient follow-up by standardizing their care.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronic hypercapnic respiratory failure treated by home non-invasive ventilation (NIV) | – | Device: NIV cards, Other: Medical file |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with chronic hypercapnic respiratory failure, treated with NIV at home, followed at the CHRU of Nancy in the UMA department between 11/01/2020 and 05/30/2021
Key inclusion criteria (3 listed)
- Major patients
- Patients with chronic hypercapnic respiratory failure with a validated indication of long-term NIV
- Follow-up at the CHRU of Nancy at "Unité de Médecine Ambulatoire" (UMA) department between 11/01/2020 and 05/30/2021
Key exclusion criteria (3 listed)
- Data not usable / missing
- Tracheal ventilation
- Patients' opposition to the use of their data for the purposes of this research
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NIV cardsReading the data available on the NIV cards | Device | Chronic hypercapnic respiratory failure treated by home non-invasive ventilation (NIV) |
| Medical fileUsing the data available in the medical file including clinical data, blood gas results, nocturnal oximetry results | Other | Chronic hypercapnic respiratory failure treated by home non-invasive ventilation (NIV) |
Primary outcome
Agreement of responses to a standardized NIV reading grid between 2 observers
Time frame: Day 0
1 secondary outcome
Comparison of the results between two observers between the method of reading NIV card usually performed in the department and this same method supplemented with a standardized NIV reading grid
Time frame: Day 0
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2021.
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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.
Julien Soler study director
CentraHNF
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 Chronic Hypercapnic Respiratory Failure, run by Central Hospital, Nancy, France at 1 site in France.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 4 May 2021. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Julien Soler (+33647961454, soler.julien@yahoo.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Agreement of responses to a standardized NIV reading grid between 2 observers (time frame: Day 0). 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 4 May 2021.