Post-extubation Respiratory FailurePhase 3NCT01191489
High-flow Conditioned Oxygen Therapy Versus Non-invasive Ventilation: Prevention of Post-extubation Failure
A Phase 3 study testing High Flow Conditioned Oxygen Therapy in High Risk Patients, Non-invasive mechanical ventilation and Conventional Oxygen Therapy in people with Post-extubation Respiratory Failure, run by Hospital Infanta Sofia at 2 sites in Spain.
Trial summary
The main aim is to demonstrate whether the high flow conditioned oxygen therapy reduces the reintubation rate. Post-extubation respiratory failure risk will be stratified (as the randomization). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-extubation Respiratory Failure
- What is being tested?
- High Flow Conditioned Oxygen Therapy in High Risk Patients, Non-invasive mechanical ventilation and Conventional Oxygen Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,042 participants
- Where
- 2 sitesSpain
- Study dates
- Sep 2012to Sep 2014
- Phase
- Phase 3
- 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
- Low Risk Patients:
- Any extubated patients after tolerating a spontaneous breathing trial.
- High Risk Patients:
- Any extubated patients after >48 hours under mechanical ventilation and any of the following:
- >65 years
- cardiac failure as the primary indication of mechanical ventilation
Show all 13Show fewer
- COPD
- APACHE II >12 points the extubation day
- BMI >30
- inability to manage respiratory secretions
- 1 failed spontaneous breathing trial
- 1 comorbidity
- 7 days under mechanical ventilation
Who cannot join
- <18 years
- thacheotomized patients
- recent facial or cervical trauma/surgery
- active gastro-intestinal bleeding
- lack of cooperation and patients with any failed spontaneous breathing trial because of hypercapnia development.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Hospital General de Ciudad Real
Ciudad Real, Ciudad Real, 13005
Hospital Infanta Sofia
San Sebastián de los Reyes, Madrid, 28703
About this study
Official title: Comparison Between High-flow Conditioned Oxygen Therapy and Non-invasive Ventilation in Prevention of Post-extubation Respiratory Failure. A Randomized Controlled Trial
The main aim is to demonstrate whether the high flow conditioned oxygen therapy reduces the reintubation rate. Post-extubation respiratory failure risk will be stratified (as the randomization). In high risk patients high flow conditioned oxygen therapy will be compared with with not conditioned non-invasive mechanical ventilation. In low risk patients comparison will be conventional oxygen therapy. Hypercapnic patients will be excluded.
- Conditions
- Post-extubation Respiratory Failure
- Being tested
- High Flow Conditioned Oxygen Therapy in High Risk Patients, Non-invasive mechanical ventilation, Conventional Oxygen Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Flow Conditioned Oxygen Therapy in High Risk PatientsDevice
OptiFlow system (R) with nasal cannula.
Non-invasive mechanical ventilationDevice
Bilevel pressure support through a facial mask
Conventional Oxygen TherapyDevice
Conventional Oxygen Therapy with nasal cannula or Venturi facial mask.
| Study group | Role | What they receive |
|---|---|---|
| High Flow Conditioned Oxygen Therapy in high risk patients | Experimental | Not described Receives: Device: High Flow Conditioned Oxygen Therapy in High Risk Patients |
| Non-invasive mechanical ventilation in High Risk Patients | Active comparator | Not described Receives: Device: Non-invasive mechanical ventilation |
| High Flow Conditioned Oxygen Therapy in Low Risk Patients | Experimental | Not described Receives: Device: High Flow Conditioned Oxygen Therapy in High Risk Patients |
| Conventional Oxygen Therapy in Low Risk Patients | Active comparator | Not described Receives: Device: Conventional Oxygen Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-extubation respiratory failure and Reintubation rate
Measured: 3 months
Secondary outcomes (6)
Intensive Care Unit mortality rate
Measured: 3 month
Hospital mortality rate
Measured: 6 months
Intensive Care Unit length of stay
Measured: 3 months
Hospital length of stay
Measured: 6 months
Nosocomial pneumonia rate
Measured: 3 months
Tracheobronchitis rate
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2010 (estimated)
- Study startSep 2012
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Post-extubation 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 1,042 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Infanta Sofia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gonzalo Hernandez Martinez, Hospital Infanta Sofia
- Investigators
- Gonzalo Hernandez, MD, Study chair, Hospital Infanta Sofia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01191489
- Sponsor's protocol ID
- HULP-3116
- Status last verified
- Sep 2014
- First submitted
- 27 Aug 2010
- Last updated
- 12 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Rodriguez Villamizar P, Thille AW, Marquez Doblas M, Frat JP, Leal Sanz P, Alonso E, Pais V, Morales G, Colinas L, Propin A, Fernandez Olivares A, Martinez Balaguer M, Alvaredo Rodrigo D, Hernandez G. Best clinical model predicting extubation failure: a diagnostic accuracy post hoc analysis. Intensive Care Med. 2025 Jan;51(1):106-114. doi: 10.1007/s00134-024-07758-0. Epub 2025 Jan 7.
PubMed 39774863Hernandez G, Vaquero C, Colinas L, Cuena R, Gonzalez P, Canabal A, Sanchez S, Rodriguez ML, Villasclaras A, Fernandez R. Effect of Postextubation High-Flow Nasal Cannula vs Noninvasive Ventilation on Reintubation and Postextubation Respiratory Failure in High-Risk Patients: A Randomized Clinical Trial. JAMA. 2016 Oct 18;316(15):1565-1574. doi: 10.1001/jama.2016.14194.
PubMed 27706464Hernandez G, Vaquero C, Gonzalez P, Subira C, Frutos-Vivar F, Rialp G, Laborda C, Colinas L, Cuena R, Fernandez R. Effect of Postextubation High-Flow Nasal Cannula vs Conventional Oxygen Therapy on Reintubation in Low-Risk Patients: A Randomized Clinical Trial. JAMA. 2016 Apr 5;315(13):1354-61. doi: 10.1001/jama.2016.2711.
PubMed 26975498
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between High-flow Conditioned Oxygen Therapy and Non-invasive Ventilation in Prevention of Post-extubation Respiratory Failure. A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01191489
- Acronym / sponsor ID
- HULP-3116
- Conditions
- Post-extubation Respiratory Failure
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,042 participants (actual)
- Lead sponsor
- Hospital Infanta SofiaUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 30 Aug 2010 (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 main aim is to demonstrate whether the high flow conditioned oxygen therapy reduces the reintubation rate. Post-extubation respiratory failure risk will be stratified (as the randomization). In high risk patients high flow conditioned oxygen therapy will be compared with with not conditioned non-invasive mechanical ventilation. In low risk patients comparison will be conventional oxygen therapy. Hypercapnic patients will be excluded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| High Flow Conditioned Oxygen Therapy in high risk patients | Experimental | Device: High Flow Conditioned Oxygen Therapy in High Risk Patients |
| Non-invasive mechanical ventilation in High Risk Patients | Active comparator | Device: Non-invasive mechanical ventilation |
| High Flow Conditioned Oxygen Therapy in Low Risk Patients | Experimental | Device: High Flow Conditioned Oxygen Therapy in High Risk Patients |
| Conventional Oxygen Therapy in Low Risk Patients | Active comparator | Device: Conventional Oxygen Therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Low Risk Patients:
- Any extubated patients after tolerating a spontaneous breathing trial.
- High Risk Patients:
- Any extubated patients after >48 hours under mechanical ventilation and any of the following:
- >65 years
Key exclusion criteria (5 listed)
- <18 years
- thacheotomized patients
- recent facial or cervical trauma/surgery
- active gastro-intestinal bleeding
- lack of cooperation and patients with any failed spontaneous breathing trial because of hypercapnia development.
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 |
|---|---|---|
| High Flow Conditioned Oxygen Therapy in High Risk PatientsOptiFlow system (R) with nasal cannula. | Device | High Flow Conditioned Oxygen Therapy in Low Risk Patients, High Flow Conditioned Oxygen Therapy in high risk patients |
| Non-invasive mechanical ventilationBilevel pressure support through a facial mask | Device | Non-invasive mechanical ventilation in High Risk Patients |
| Conventional Oxygen TherapyConventional Oxygen Therapy with nasal cannula or Venturi facial mask. | Device | Conventional Oxygen Therapy in Low Risk Patients |
Primary outcome
Post-extubation respiratory failure and Reintubation rate
Time frame: 3 months
6 secondary outcomes
Intensive Care Unit mortality rate
Time frame: 3 month
Hospital mortality rate
Time frame: 6 months
Intensive Care Unit length of stay
Time frame: 3 months
Hospital length of stay
Time frame: 6 months
Nosocomial pneumonia rate
Time frame: 3 months
Tracheobronchitis rate
Time frame: 3 months
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 12 Sep 2014.
- Derived from this study: PubMed 39774863Rodriguez Villamizar P, Thille AW, Marquez Doblas M, Frat JP, Leal Sanz P, Alonso E, Pais V, Morales G, Colinas L, Propin A, Fernandez Olivares A, Martinez Balaguer M, Alvaredo Rodrigo D, Hernandez G. Best clinical model predicting extubation failure: a diagnostic accuracy post hoc analysis. Intensive Care Med. 2025 Jan;51(1):106-114. doi: 10.1007/s00134-024-07758-0. Epub 2025 Jan 7.
- Derived from this study: PubMed 27706464Hernandez G, Vaquero C, Colinas L, Cuena R, Gonzalez P, Canabal A, Sanchez S, Rodriguez ML, Villasclaras A, Fernandez R. Effect of Postextubation High-Flow Nasal Cannula vs Noninvasive Ventilation on Reintubation and Postextubation Respiratory Failure in High-Risk Patients: A Randomized Clinical Trial. JAMA. 2016 Oct 18;316(15):1565-1574. doi: 10.1001/jama.2016.14194.
- Derived from this study: PubMed 26975498Hernandez G, Vaquero C, Gonzalez P, Subira C, Frutos-Vivar F, Rialp G, Laborda C, Colinas L, Cuena R, Fernandez R. Effect of Postextubation High-Flow Nasal Cannula vs Conventional Oxygen Therapy on Reintubation in Low-Risk Patients: A Randomized Clinical Trial. JAMA. 2016 Apr 5;315(13):1354-61. doi: 10.1001/jama.2016.2711.
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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.
Gonzalo Hernandez, MD study chair
Hospital Infanta Sofia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing High Flow Conditioned Oxygen Therapy in High Risk Patients, Non-invasive mechanical ventilation and Conventional Oxygen Therapy in people with Post-extubation Respiratory Failure, run by Hospital Infanta Sofia at 2 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 13 inclusion and 5 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 12 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Post-extubation respiratory failure and Reintubation rate (time frame: 3 months). 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 NCT01191489, which also lists 3 linked publications.
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 Sep 2014.