Acute Respiratory FailureNCT02834325
Predicting Success of HFNC: The Utility of the ROX Index
An observational study of Acute Respiratory Failure and Pneumonia, run by Hospital Universitari Vall d'Hebron Research Institute.
Trial summary
The purpose of the study was to describe early predictors and to develop a prediction tool that accurately identifies the need for mechanical ventilation in pneumonia patients with acute respiratory failure treated with High Flow nasal cannula. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Failure, Pneumonia
- What is being tested?
- mechanical ventilation
- Type of treatment
- Surgery or procedure
- How many people
- 201 participants
- Where
- No sites listed yet
- Study dates
- Jan 2009to Dec 2012
- 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: patients with acute respiratory failure admitted to intensive care unit receiving high-flow nasal cannula treatment.
Who may be able to join
- diagnosis of acute respiratory failure secondary to pneumonia receiving HFNC therapy
Who cannot join
- younger than 18 years old
- indication for mechanical ventilation at ICU admission
- limitation of therapeutic effort
About this study
Official title: Predicting Failure of High Flow Nasal Cannula in Pneumonia Patients With Hypoxemic Respiratory Failure: The Utility of ROX Index
The purpose of the study was to describe early predictors and to develop a prediction tool that accurately identifies the need for mechanical ventilation in pneumonia patients with acute respiratory failure treated with High Flow nasal cannula.
Read the detailed description
Purpose The purpose of the study is to describe early predictors and to develop a prediction tool that accurately identifies the need for mechanical ventilation (MV) in pneumonia patients with hypoxemic acute respiratory failure (ARF) treated with high-flow nasal cannula (HFNC).
Materials and methods This is a 4-year prospective observational 2-center cohort study including patients with severe pneumonia treated with HFNC. High-flow nasal cannula failure was defined as need for MV. ROX index was defined as the ratio of pulse oximetry/fraction of inspired oxygen to respiratory rate.
- Conditions
- Acute Respiratory Failure, Pneumonia
- Being tested
- mechanical ventilation
- Keywords
- high flow nasal cannula, success, failure, ROX index
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mechanical ventilationProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| exit | HFNC with no need for mechanical ventilation | |
| failure | HFNC with need for mechanical ventilation Receives: Procedure: mechanical ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
prediction of need for mechanical ventilation using ROX index
participants will be followed during their stay in the ICU registering the days with HFNC treatment and their need or not for mechanical ventilation.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2016 (estimated)
- Study startJan 2009
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory FailureStudies of the same condition, open and under way.
- More trials run by Hospital Universitari Vall d'Hebron Research InstituteThe 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
- Prospective
- Enrolment
- 201 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02834325
- Sponsor's protocol ID
- PR(AG)101/2011
- Status last verified
- Jul 2016
- First submitted
- 31 Aug 2015
- Last updated
- 15 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting Failure of High Flow Nasal Cannula in Pneumonia Patients With Hypoxemic Respiratory Failure: The Utility of ROX Index
- ClinicalTrials.gov ID
- NCT02834325
- Acronym / sponsor ID
- PR(AG)101/2011
- Conditions
- Acute Respiratory Failure, Pneumonia
- Keywords
- high flow nasal cannula, success, failure, ROX index
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 15 Jul 2016 (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 was to describe early predictors and to develop a prediction tool that accurately identifies the need for mechanical ventilation in pneumonia patients with acute respiratory failure treated with High Flow nasal cannula.
Detailed description
Purpose The purpose of the study is to describe early predictors and to develop a prediction tool that accurately identifies the need for mechanical ventilation (MV) in pneumonia patients with hypoxemic acute respiratory failure (ARF) treated with high-flow nasal cannula (HFNC).
Materials and methods This is a 4-year prospective observational 2-center cohort study including patients with severe pneumonia treated with HFNC. High-flow nasal cannula failure was defined as need for MV. ROX index was defined as the ratio of pulse oximetry/fraction of inspired oxygen to respiratory rate.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| exit | – | –HFNC with no need for mechanical ventilation |
| failure | – | Procedure: mechanical ventilationHFNC with need for mechanical ventilation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with acute respiratory failure admitted to intensive care unit receiving high-flow nasal cannula treatment.
Key inclusion criteria (1 listed)
- diagnosis of acute respiratory failure secondary to pneumonia receiving HFNC therapy
Key exclusion criteria (3 listed)
- younger than 18 years old
- indication for mechanical ventilation at ICU admission
- limitation of therapeutic effort
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 |
|---|---|---|
| mechanical ventilation | Procedure or surgery | failure |
Primary outcome
prediction of need for mechanical ventilation using ROX index
Time frame: through study completion, an average of 1 year
participants will be followed during their stay in the ICU registering the days with HFNC treatment and their need or not for mechanical ventilation.
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 15 Jul 2016.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Respiratory Failure and Pneumonia, run by Hospital Universitari Vall d'Hebron Research Institute.
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 1 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: finished, as of the sponsor's last update on 15 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
prediction of need for mechanical ventilation using ROX index (time frame: through study completion, an average of 1 year). 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 15 Jul 2016.