Acute Hypercapnic Respiratory FailureTMIRANCT04650412
Integrated Care of Co-morbidities vs Standard Care After AHRF in the Intensive Care Unit
A study testing Bundle of comorbidities care in people with Acute Hypercapnic Respiratory Failure, run by CTU at 3 sites in 2 countries.
Trial summary
The study will assess the potential benefit of implementing a complex bundle of interventions to treat important - often unrecognized - comorbidities in patients surviving an episode of Acute Hypercapnic Respiratory Failure (AHRF). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Hypercapnic Respiratory Failure
- What is being tested?
- Bundle of comorbidities care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 188 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 28 May 2018to 31 Jul 2022
- Phase
- Interventional
- 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
Who may be able to join
- Consent form signed
- Acute hypercapnic respiratory failure defined as PaCO2 > 6.3 kPa requiring invasive or non-invasive mechanical ventilation in the ICU
Who cannot join
- Age < 18 years old
- Known or suspected neuromuscular diseases
- Pregnancy
- Iatrogenic respiratory failure (i.e. drug overdose, AHRF after starting opiates or increasing opiates dose)
- Life expectancy < 3 months
- Confusion or major psychiatric illness
- Patient unable to be weaned from NIV
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Switzerland2 sites
Geneva University Hospitals
Geneva, 1211
Centre Hospitalier Universitaire Vaudois
Lausanne, 1011
About this study
Official title: Integrated Care of Co-morbidities vs Standard Care After Acute Hypercapnic Respiratory Failure in the Intensive Care Unit: a Randomized Controlled Trial
The study will assess the potential benefit of implementing a complex bundle of interventions to treat important - often unrecognized - comorbidities in patients surviving an episode of Acute Hypercapnic Respiratory Failure (AHRF). This study will also provide a comparative analysis of the costs and health consequences of two alternative strategies to inform decision making about healthcare. All interventions are individually evidence-based and seem sound to hypothesize that implementing such interventions might improve patient's outcome and reduce the financial burder of repeated hospitalization in AHRF survivors.
- Conditions
- Acute Hypercapnic Respiratory Failure
- Being tested
- Bundle of comorbidities care
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bundle of comorbidities careOther
Pulmonary function tests, blood gas analysis, transthoracic echocardiography, sleep study after stabilization of patient's index clinical condition, thus 1 month after hospital discharge
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Bundle of comorbidities care Receives: Other: Bundle of comorbidities care |
| Control | No intervention | Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital readmission
Hospital or ICU readmission
Measured: 1-year observation
Secondary outcomes (2)
Health Related Quality of Life
Hospital Anxiety and Depression scale (0 to 21 points with 21 indicating higher levels of anxiety and depression) Saint George Questionnaire (0-100 with 100 indicating more limitations) Impact of dyspea on daily activities measured by mMRC (0 to IV with IV indication more impact of dyspnea)
Measured: Measured at regular 3, 6 and 12 months visits following patient's hospital discharge
Cost-effectiveness
Costs related to unplanned emergency visits and hospital length of stay following readmission
Measured: 1-year observation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2020
- Study start28 May 2018
- Primary completion31 Jul 2022
- Study completion31 Jul 2022
Why it stopped: delayed recruitment and lack of refinancing
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Hypercapnic Respiratory FailureStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial (bundle of comorbidity care vs standard care)
- Masking
- None (open label)
- Enrolment
- 188 participants (actual)
Sponsor and investigators
- Lead sponsor
- CTU
- Sponsor type
- University, hospital or other
- Collaborators
- Dan Adler is not working anymore at UGeneva, and nobody replaced him. This study is stopped
- Responsible party
- Sponsor-investigator, CTU, University Hospital, Geneva
- Investigators
- Dan Adler, MD, Principal investigator, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04650412
- Sponsor's protocol ID
- 2016-01879
- Other IDs
- 2016
- Acronym
- TMIRA
- Status last verified
- May 2023
- First submitted
- 18 Nov 2020
- Last updated
- 12 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated Care of Co-morbidities vs Standard Care After Acute Hypercapnic Respiratory Failure in the Intensive Care Unit: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04650412
- Acronym / sponsor ID
- TMIRA / 2016-01879
- Conditions
- Acute Hypercapnic Respiratory Failure
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: delayed recruitment and lack of refinancing
- Enrolment
- 188 participants (actual)
- Lead sponsor
- CTUUniversity, hospital or other
- Collaborators
- Dan Adler is not working anymore at UGeneva, and nobody replaced him. This study is stopped
- Study start
- 28 May 2018 (actual)
- Primary completion
- 31 Jul 2022 (actual)
- Study completion
- 31 Jul 2022 (actual)
- First posted
- 2 Dec 2020 (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.
The study will assess the potential benefit of implementing a complex bundle of interventions to treat important - often unrecognized - comorbidities in patients surviving an episode of Acute Hypercapnic Respiratory Failure (AHRF). This study will also provide a comparative analysis of the costs and health consequences of two alternative strategies to inform decision making about healthcare. All interventions are individually evidence-based and seem sound to hypothesize that implementing such interventions might improve patient's outcome and reduce the financial burder of repeated hospitalization in AHRF survivors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial (bundle of comorbidity care vs standard care)
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Bundle of comorbidities careBundle of comorbidities care |
| Control | No intervention | –Standard care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Consent form signed
- Acute hypercapnic respiratory failure defined as PaCO2 > 6.3 kPa requiring invasive or non-invasive mechanical ventilation in the ICU
Key exclusion criteria (7 listed)
- Age < 18 years old
- Known or suspected neuromuscular diseases
- Pregnancy
- Iatrogenic respiratory failure (i.e. drug overdose, AHRF after starting opiates or increasing opiates dose)
- Life expectancy < 3 months
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 |
|---|---|---|
| Bundle of comorbidities carePulmonary function tests, blood gas analysis, transthoracic echocardiography, sleep study after stabilization of patient's index clinical condition, thus 1 month after hospital discharge | Other | Intervention |
Primary outcome
Hospital readmission
Time frame: 1-year observation
Hospital or ICU readmission
2 secondary outcomes
Health Related Quality of Life
Time frame: Measured at regular 3, 6 and 12 months visits following patient's hospital discharge
Cost-effectiveness
Time frame: 1-year observation
Results and safety
The study was stopped early (reason given: delayed recruitment and lack of refinancing). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2023.
- Individual participant dataSharing planned: No
Related trials for Acute Hypercapnic Respiratory Failure
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ICU-SUCCEED for Survivors of Acute Respiratory Failure and Their Caregivers
Acute Respiratory Failure, Critical Illness
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Bedside Spirometry for Acute Lung Injury
Respiratory Insufficiency
Recruiting
Management of Post-operative Respiratory Failure by Using NIV and High Velocity Nasal Insufflation (HVNI)
Respiratory Failure Without Hypercapnia, Respiratory Failure With Hypercapnia
Not yet recruiting
Extracorporeal Carbon Dioxide Removal Plus Noninvasive Ventilation in Patients With COPD Not Eligible for Intubation
Acute Exacerbation of Chronic Obstructive Pulmonary Disease
Recruiting
Nasal High Flow Versus Non-invasive Ventilation for Early Treatment of Acute Exacerbation of Chronic Obstructive Pulmonary Disease With Hypercapnic Acidosis
Acute Exacerbation of Chronic Obstructive Pulmonary Disease, Hypercapnic Acidosis
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.
Dan Adler, MD principal investigator
University Hospital, Geneva
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bundle of comorbidities care in people with Acute Hypercapnic Respiratory Failure, run by CTU at 3 sites in 2 countries.
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 2 inclusion and 7 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: stopped early, as of the sponsor's last update on 12 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Switzerland, 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?
The study was stopped early (reason given: delayed recruitment and lack of refinancing). Results are not available in the source record.
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?
Hospital readmission (time frame: 1-year observation). 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 12 May 2023.