Extubation FailureHINFORNCT04125342
Postextubation High-flow Therapy vs Noninvasive Ventilation in Obese or at High-risk Patients
A study testing Preventive Conditioned NIV Therapy after planned extubation and Preventive HFOT after planned extubation in people with Extubation Failure, run by Hospital Virgen de la Salud at 2 sites in Spain.
Trial summary
The main aim is to demonstrate whether reintubation rate is lower with preventive conditioned noninvasive ventilation (NIV) rather than with High-flow oxygen therapy (HFOT) in obese intermediate-risk patients and in high-risk patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Extubation Failure
- What is being tested?
- Preventive Conditioned NIV Therapy after planned extubation and Preventive HFOT after planned extubation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 326 participants
- Where
- 2 sitesSpain
- Study dates
- 1 Jun 2020to 1 Dec 2021
- 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
- High-Risk Patients: Patients under mechanical ventilation for more than 24 hours considered at high risk according to the presence of more than 3 of the following risk factors:
- >65 years.
- Cardiac failure as the primary indication of mechanical ventilation.
- Moderate to severe chronic obstructive pulmonary disease.
- APACHE II >12 points the extubation day.
- Body mass index >30.
Show all 22Show fewer
- Inability to manage respiratory secretions.
- Not simple weaning.
- More than 1 comorbidity.
- More than 7 days under mechanical ventilation.
- Hypercapnia during the spontaneous breathing trial.
- Airway patency problems.
- Obese Intermediate Risk Patients: Patients under mechanical ventilation for more than 24 hours with a Body mass index >30 and considered at intermediate risk according to the presence of less than 3 of the following risk factors:
- >65 years.
- Cardiac failure as the primary indication of mechanical ventilation.
- Moderate to severe chronic obstructive pulmonary disease.
- APACHE II >12 points the extubation day.
- Inability to manage respiratory secretions.
- Not simple weaning.
- More than 1 comorbidity.
- More than 7 days under mechanical ventilation.
- Airway patency problems.
Who cannot join
- <18 years.
- Thacheotomized patients.
- Contraindications for NIV (recent facial or cervical trauma/surgery, active gastro-intestinal bleeding, lack of cooperation).
- Unscheduled extubation.
- Do not reintubate orders.
- No informed consent.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
La princesa University Hospital
Madrid, 28006
Hospital Virgen de la Salud
Toledo, Castille-La Mancha, 45007
About this study
Official title: Effect of Postextubation High-Flow Nasal Cannula vs Noninvasive Ventilation on Reintubation in Obese or High-Risk Patients. A Randomized Clinical Trial.
The main aim is to demonstrate whether reintubation rate is lower with preventive conditioned noninvasive ventilation (NIV) rather than with High-flow oxygen therapy (HFOT) in obese intermediate-risk patients and in high-risk patients.
- Conditions
- Extubation Failure
- Being tested
- Preventive Conditioned NIV Therapy after planned extubation, Preventive HFOT after planned extubation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preventive Conditioned NIV Therapy after planned extubationDevice
Conditioned NIV during 48 hours following extubation.
Preventive HFOT after planned extubationDevice
HFOT set according to patients tolerance during 48 hours following extubation
| Study group | Role | What they receive |
|---|---|---|
| Conditioned NIV in High Risk Patients | Experimental | Not described Receives: Device: Preventive Conditioned NIV Therapy after planned extubation |
| HFOT in High Risk Patients | Active comparator | Not described Receives: Device: Preventive HFOT after planned extubation |
| Conditioned NIV in Obese Intermediate Risk Patients | Experimental | Not described Receives: Device: Preventive Conditioned NIV Therapy after planned extubation |
| HFOT in Obese Intermediate Risk Patient | Active comparator | Not described Receives: Device: Preventive HFOT after planned extubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reintubation rate
Measured: 7 days
Secondary outcomes (5)
Intensive Care Unit mortality rate
Measured: 3 months
Hospital mortality rate
Measured: 3 months
Intensive Care Unit length of stay
Measured: 3 months
Hospital length of stay
Measured: 6 months
Respiratory infection rate
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2019
- Study start1 Jun 2020
- Primary completion1 Jun 2021
- Study completion1 Dec 2021
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 Extubation 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 326 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Virgen de la Salud
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gonzalo Hernandez Martinez, Hospital Virgen de la Salud
- Investigators
- Gonzalo Hernandez, Study chair, SESCAM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04125342
- Sponsor's protocol ID
- 25/9/2019 nº17
- Acronym
- HINFOR
- Status last verified
- Mar 2022
- First submitted
- 3 Oct 2019
- Last updated
- 17 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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, Dianti J, Paredes I, Moran F, Marquez M, Calle A, Colinas L, Alonso G, Carneiro P, Morales G, Suarez-Sipmann F, Canabal A, Goligher E, Roca O. Humidified Noninvasive Ventilation versus High-Flow Therapy to Prevent Reintubation in Patients with Obesity: A Randomized Clinical Trial. Am J Respir Crit Care Med. 2025 Feb;211(2):222-229. doi: 10.1164/rccm.202403-0523OC.
PubMed 39514845Hernandez G, Paredes I, Moran F, Buj M, Colinas L, Rodriguez ML, Velasco A, Rodriguez P, Perez-Pedrero MJ, Suarez-Sipmann F, Canabal A, Cuena R, Blanch L, Roca O. Effect of postextubation noninvasive ventilation with active humidification vs high-flow nasal cannula on reintubation in patients at very high risk for extubation failure: a randomized trial. Intensive Care Med. 2022 Dec;48(12):1751-1759. doi: 10.1007/s00134-022-06919-3. Epub 2022 Nov 18.
PubMed 36400984
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Postextubation High-Flow Nasal Cannula vs Noninvasive Ventilation on Reintubation in Obese or High-Risk Patients. A Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT04125342
- Acronym / sponsor ID
- HINFOR / 25/9/2019 nº17
- Conditions
- Extubation Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 326 participants (actual)
- Lead sponsor
- Hospital Virgen de la SaludUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 14 Oct 2019 (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 main aim is to demonstrate whether reintubation rate is lower with preventive conditioned noninvasive ventilation (NIV) rather than with High-flow oxygen therapy (HFOT) in obese intermediate-risk patients and in high-risk patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Conditioned NIV in High Risk Patients | Experimental | Device: Preventive Conditioned NIV Therapy after planned extubation |
| HFOT in High Risk Patients | Active comparator | Device: Preventive HFOT after planned extubation |
| Conditioned NIV in Obese Intermediate Risk Patients | Experimental | Device: Preventive Conditioned NIV Therapy after planned extubation |
| HFOT in Obese Intermediate Risk Patient | Active comparator | Device: Preventive HFOT after planned extubation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- High-Risk Patients: Patients under mechanical ventilation for more than 24 hours considered at high risk according to the presence of more than 3 of the following risk factors:
- Obese Intermediate Risk Patients: Patients under mechanical ventilation for more than 24 hours with a Body mass index >30 and considered at intermediate risk according to the presence of less than 3 of the following risk factors:
Key exclusion criteria (6 listed)
- <18 years.
- Thacheotomized patients.
- Contraindications for NIV (recent facial or cervical trauma/surgery, active gastro-intestinal bleeding, lack of cooperation).
- Unscheduled extubation.
- Do not reintubate orders.
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 |
|---|---|---|
| Preventive Conditioned NIV Therapy after planned extubationConditioned NIV during 48 hours following extubation. | Device | Conditioned NIV in High Risk Patients, Conditioned NIV in Obese Intermediate Risk Patients |
| Preventive HFOT after planned extubationHFOT set according to patients tolerance during 48 hours following extubation | Device | HFOT in High Risk Patients, HFOT in Obese Intermediate Risk Patient |
Primary outcome
Reintubation rate
Time frame: 7 days
5 secondary outcomes
Intensive Care Unit mortality rate
Time frame: 3 months
Hospital mortality rate
Time frame: 3 months
Intensive Care Unit length of stay
Time frame: 3 months
Hospital length of stay
Time frame: 6 months
Respiratory infection rate
Time frame: 6 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 17 Mar 2022.
- 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 39514845Hernandez G, Dianti J, Paredes I, Moran F, Marquez M, Calle A, Colinas L, Alonso G, Carneiro P, Morales G, Suarez-Sipmann F, Canabal A, Goligher E, Roca O. Humidified Noninvasive Ventilation versus High-Flow Therapy to Prevent Reintubation in Patients with Obesity: A Randomized Clinical Trial. Am J Respir Crit Care Med. 2025 Feb;211(2):222-229. doi: 10.1164/rccm.202403-0523OC.
- Derived from this study: PubMed 36400984Hernandez G, Paredes I, Moran F, Buj M, Colinas L, Rodriguez ML, Velasco A, Rodriguez P, Perez-Pedrero MJ, Suarez-Sipmann F, Canabal A, Cuena R, Blanch L, Roca O. Effect of postextubation noninvasive ventilation with active humidification vs high-flow nasal cannula on reintubation in patients at very high risk for extubation failure: a randomized trial. Intensive Care Med. 2022 Dec;48(12):1751-1759. doi: 10.1007/s00134-022-06919-3. Epub 2022 Nov 18.
- Individual participant dataSharing planned: No
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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 study chair
SESCAM
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preventive Conditioned NIV Therapy after planned extubation and Preventive HFOT after planned extubation in people with Extubation Failure, run by Hospital Virgen de la Salud 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 22 inclusion and 6 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 17 Mar 2022. 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.
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?
Reintubation rate (time frame: 7 days). 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 NCT04125342, 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 17 Mar 2022.