Hypercapnic Respiratory FailurePhase 4NCT00775710
Clinical Trial Assessing Two Protocols to Withdraw Non-invasive Ventilation in Hypercapnic Respiratory Failure
A Phase 4 study testing Nocturnal non-invasive ventilation in people with Hypercapnic Respiratory Failure, run by Hospital Clinic of Barcelona at 3 sites in Spain.
Trial summary
The purpose of the study is to determine the optimal method to withdraw non-invasive ventilation after an episode of hypercapnic respiratory failure. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hypercapnic Respiratory Failure
- What is being tested?
- Nocturnal non-invasive ventilation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 3 sitesSpain
- Study dates
- Mar 2006to Aug 2010
- Phase
- Phase 4
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Acute hypercapnic respiratory failure.
- Use of NIV to treat respiratory failure.
- Persistence of hypercapnia after discontinuation of NIV
Who cannot join
- Home NIV
- Facial or cranial trauma or surgery,
- Recent gastric or esophageal surgery,
- Active upper gastrointestinal bleeding,
- Excessive amount of respiratory secretions,
- Tracheostomy
- Lack of cooperation
Trial locations and contacts
3 sites in 1 country.
Spain3 sites
Hospital del Mar
Barcelona, Barcelona, 08003
Hospital de Sant Pau
Barcelona, Barcelona, 08025
Hospital Clinic
Barcelona, Barcelona, 08036
About this study
Official title: A Randomized Controlled Trial Comparing Two Protocols to Withdraw Non-invasive Ventilation (NIV) After an Episode of Hypercapnic Respiratory Failure
The purpose of the study is to determine the optimal method to withdraw non-invasive ventilation after an episode of hypercapnic respiratory failure.
- Conditions
- Hypercapnic Respiratory Failure
- Being tested
- Nocturnal non-invasive ventilation
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nocturnal non-invasive ventilationDevice
Prolongation of non-invasive ventilation during 3 nights.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Non-invasive ventilation is maintained during three nights after recovery of an episode of hypercapnic respiratory failure. Receives: Device: Nocturnal non-invasive ventilation |
| 2 | No intervention | Discontinuation of NIV after the recovery of hypercapnic respiratory failure, without prolong it during night. |
What is being measured
The primary outcome is the main question the study is designed to answer.
New episode of hypercapnic respiratory failure after discontinuation of non-invasive ventilation
Measured: At the end of enrollment time
Secondary outcomes (2)
Incidence of long term dependency on non-invasive ventilation
Measured: At the end of enrollment time
Hospital and 6-month survival
Measured: At the end of enrollment time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2008 (estimated)
- Study startMar 2006
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Investigators
- Jacobo Sellares, MD, Principal investigator, Hospital Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00775710
- Sponsor's protocol ID
- NIV-JS1
- Status last verified
- Oct 2008
- First submitted
- 17 Oct 2008
- Last updated
- 22 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Sellares J, Ferrer M, Anton A, Loureiro H, Bencosme C, Alonso R, Martinez-Olondris P, Sayas J, Penacoba P, Torres A. Discontinuing noninvasive ventilation in severe chronic obstructive pulmonary disease exacerbations: a randomised controlled trial. Eur Respir J. 2017 Jul 5;50(1):1601448. doi: 10.1183/13993003.01448-2016. Print 2017 Jul.
PubMed 28679605
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing Two Protocols to Withdraw Non-invasive Ventilation (NIV) After an Episode of Hypercapnic Respiratory Failure
- ClinicalTrials.gov ID
- NCT00775710
- Acronym / sponsor ID
- NIV-JS1
- Conditions
- Hypercapnic Respiratory Failure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Study start
- Mar 2006
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 20 Oct 2008 (estimated)
- 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 purpose of the study is to determine the optimal method to withdraw non-invasive ventilation after an episode of hypercapnic respiratory failure.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Device: Nocturnal non-invasive ventilationNon-invasive ventilation is maintained during three nights after recovery of an episode of hypercapnic respiratory failure. |
| 2 | No intervention | –Discontinuation of NIV after the recovery of hypercapnic respiratory failure, without prolong it during night. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Acute hypercapnic respiratory failure.
- Use of NIV to treat respiratory failure.
- Persistence of hypercapnia after discontinuation of NIV
Key exclusion criteria (7 listed)
- Home NIV
- Facial or cranial trauma or surgery,
- Recent gastric or esophageal surgery,
- Active upper gastrointestinal bleeding,
- Excessive amount of respiratory secretions,
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 |
|---|---|---|
| Nocturnal non-invasive ventilationProlongation of non-invasive ventilation during 3 nights. | Device | 1 |
Primary outcome
New episode of hypercapnic respiratory failure after discontinuation of non-invasive ventilation
Time frame: At the end of enrollment time
2 secondary outcomes
Incidence of long term dependency on non-invasive ventilation
Time frame: At the end of enrollment time
Hospital and 6-month survival
Time frame: At the end of enrollment time
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 22 Jun 2011.
- Derived from this study: PubMed 28679605Sellares J, Ferrer M, Anton A, Loureiro H, Bencosme C, Alonso R, Martinez-Olondris P, Sayas J, Penacoba P, Torres A. Discontinuing noninvasive ventilation in severe chronic obstructive pulmonary disease exacerbations: a randomised controlled trial. Eur Respir J. 2017 Jul 5;50(1):1601448. doi: 10.1183/13993003.01448-2016. Print 2017 Jul.
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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.
Jacobo Sellares, MD principal investigator
Hospital Clinic
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nocturnal non-invasive ventilation in people with Hypercapnic Respiratory Failure, run by Hospital Clinic of Barcelona at 3 sites in Spain.
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 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: finished, as of the sponsor's last update on 22 Jun 2011. 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 Spain. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
New episode of hypercapnic respiratory failure after discontinuation of non-invasive ventilation (time frame: At the end of enrollment time). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00775710, which also lists 1 linked publication.
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 22 Jun 2011.