High Flow Oxygen TherapyHFNC-NIVNCT07896616
Predicting the Need for Invasive Mechanical Ventilation Using Different Risk Scores
An observational study of High Flow Oxygen Therapy and Non Invasive Ventilation (NIV), run by Ankara Ataturk Sanatorium Training and Research Hospital.
Trial summary
This prospective, single-center observational study aims to evaluate the predictive performance of the ROX index, modified ROX index, and HACOR score for the need for invasive mechanical ventilation in adult intensive care unit patients with acute respiratory failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- High Flow Oxygen Therapy, Non Invasive Ventilation (NIV)
- How many people
- 84 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2026to 1 May 2027
- How long will I take part?
- 8 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: The study population will consist of adult patients aged 18 years or older admitted to the tertiary-level Anesthesiology and Reanimation Intensive Care Units of Ankara Ataturk Sanatorium Training and Research Hospital with acute respiratory failure (Type I, Type II, or combined Type I-II) who receive high-flow nasal oxygen (HFNO), noninvasive ventilation (NIV), or sequential HFNO-NIV respiratory support. Eligible patients will be enrolled prospectively after obtaining informed consent from the patient or their legally authorized representative. Patients will be followed for 24 hours to evaluate the ability of ROX, modified ROX, and HACOR scores to predict the need for invasive mechanical ventilation. All respiratory support decisions will be made by the treating clinicians as part of routine clinical care, without any study-related intervention.
Who may be able to join
- Age 18 years or older.
- Diagnosis of acute respiratory failure.
- Type I, type II, or combined type I-II respiratory failure.
- Initiation of noninvasive respiratory support after admission to the intensive care unit.
- Written informed consent obtained from the patient or legally authorized representative.
Who cannot join
- Patients admitted to the intensive care unit already intubated.
- Patients for whom immediate invasive mechanical ventilation is decided at the initial assessment.
- Patients undergoing cardiopulmonary resuscitation during follow-up.
- Patients with missing essential clinical data.
- Patients with type III or type IV respiratory failure.
- Patients with active malignancy who are currently receiving treatment.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluation of ROX, Modified ROX, and HACOR Indices for Predicting Invasive Mechanical Ventilation Requirement in Patients Receiving HFNO and NIV
This prospective, single-center observational study aims to evaluate the predictive performance of the ROX index, modified ROX index, and HACOR score for the need for invasive mechanical ventilation in adult intensive care unit patients with acute respiratory failure.
Patients receiving high-flow nasal oxygen (HFNO), noninvasive ventilation (NIV), or sequential HFNO and NIV will be included. Patients will be followed for 24 hours, and clinical and laboratory parameters will be recorded at baseline and at 2, 6, 12, and 24 hours.
Read more
The predictive performance of these indices and their changes over time will be evaluated according to respiratory support modality and type of respiratory failure.
No additional diagnostic or therapeutic interventions will be performed as part of the study. All treatment decisions will be made by the attending clinicians according to routine clinical practice.
- Keywords
- rox index, invasive mechanical ventilation, HACOR index, modified rox index
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| HFNO Group | Patients with acute respiratory failure receiving high-flow nasal oxygen as their respiratory support modality. | |
| NIV Group | Patients with acute respiratory failure receiving noninvasive ventilation as their respiratory support modality. | |
| Sequential HFNO-NIV Group | Patients receiving sequential or alternating high-flow nasal oxygen and noninvasive ventilation during the first 24 hours of intensive care follow-up. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Predictive Performance of the ROX Index for Invasive Mechanical Ventilation Requirement
The predictive performance of the baseline ROX index for the need for invasive mechanical ventilation within 24 hours of ICU admission will be assessed using receiver operating characteristic (ROC) curve analysis. The outcome will be reported as the area under the ROC curve (AUC), ranging from 0 to 1.
Measured: Within 24 hours of ICU admission.
Predictive Performance of the Modified ROX Index for Invasive Mechanical Ventilation Requirement
The predictive performance of the baseline modified ROX index, calculated as (PaO2/FiO2)/respiratory rate, for the need for invasive mechanical ventilation within 24 hours of ICU admission will be assessed using ROC curve analysis. The outcome will be reported as the AUC, ranging from 0 to 1.
Measured: Within 24 hours of ICU admission.
Predictive Performance of the HACOR Score for Invasive Mechanical Ventilation Requirement
The predictive performance of the baseline HACOR score, incorporating heart rate, acidosis, consciousness, oxygenation, and respiratory rate, for the need for invasive mechanical ventilation within 24 hours of ICU admission will be assessed using ROC curve analysis. The outcome will be reported as the AUC, ranging from 0 to 1.
Measured: Within 24 hours of ICU admission.
Secondary outcomes (5)
Changes in ROX Score Over Time
Changes in ROX score from baseline to 2, 6, 12, and 24 hours will be evaluated in relation to invasive mechanical ventilation requirement.
Measured: Baseline, 2, 6, 12, and 24 hours.
Changes in Modified ROX Score Over Time
Changes in modified ROX score from baseline to 2, 6, 12, and 24 hours will be evaluated in relation to invasive mechanical ventilation requirement.
Measured: Baseline, 2, 6, 12, and 24 hours.
Changes in HACOR Score Over Time
Changes in HACOR score from baseline to 2, 6, 12, and 24 hours will be evaluated in relation to invasive mechanical ventilation requirement.
Measured: Baseline, 2, 6, 12, and 24 hours.
Predictive Performance According to Respiratory Support Modality
The predictive performance of ROX, modified ROX, and HACOR indices will be compared among patients receiving HFNO, NIV, or sequential HFNO-NIV support.
Measured: Within 24 hours after intensive care admission.
Predictive Performance According to Respiratory Failure Type
The predictive performance of ROX, modified ROX, and HACOR indices will be evaluated in patients with type I, type II, and combined type I-II acute respiratory failure.
Measured: Within 24 hours after intensive care admission.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 May 2027 (estimated)
- Study completion1 May 2027 (estimated)
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 High Flow Oxygen TherapyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 84 participants (estimated)
- Target duration
- 8 Months
Sponsor and investigators
- Lead sponsor
- Ankara Ataturk Sanatorium Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Aslan Mert, Ankara Ataturk Sanatorium Training and Research Hospital
- Investigators
- GÜLER ERARSLAN DOGANAY, Principal investigator, ANKARA ATATURK SANATORYUM EDUCATION AND RESEARCH HOSPİTAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07896616
- Sponsor's protocol ID
- HFNC-NIV-001
- Acronym
- HFNC-NIV
- Status last verified
- Oct 2026
- First submitted
- 18 Oct 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Okano H, Yamamoto R, Iwasaki Y, Irimada D, Konno D, Tanaka T, Oishi T, Nawa H, Yano A, Taniguchi H, Otawara M, Matsuoka A, Yamauchi M. External validation of the HACOR score and ROX index for predicting treatment failure in patients with coronavirus disease 2019 pneumonia managed on high-flow nasal cannula therapy: a multicenter retrospective observational study in Japan. J Intensive Care. 2024 Feb 15;12(1):7. doi: 10.1186/s40560-024-00720-8.
PubMed 38360681Muhetaer Y, Zhang SM, Moming A, Liu K, Zhong M. Prediction of high-flow nasal cannula failure in critically ill patients: a narrative review. J Intensive Care. 2026 Mar 3;14(1):27. doi: 10.1186/s40560-026-00871-w.
PubMed 41776692Zhou X, Liu J, Pan J, Xu Z, Xu J. The ROX index as a predictor of high-flow nasal cannula outcome in pneumonia patients with acute hypoxemic respiratory failure: a systematic review and meta-analysis. BMC Pulm Med. 2022 Apr 1;22(1):121. doi: 10.1186/s12890-022-01914-2.
PubMed 35365110
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of ROX, Modified ROX, and HACOR Indices for Predicting Invasive Mechanical Ventilation Requirement in Patients Receiving HFNO and NIV
- ClinicalTrials.gov ID
- NCT07896616
- Acronym / sponsor ID
- HFNC-NIV / HFNC-NIV-001
- Keywords
- rox index, invasive mechanical ventilation, HACOR index, modified rox index
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Ankara Ataturk Sanatorium Training and Research HospitalOther government
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 27 Oct 2026 (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.
This prospective, single-center observational study aims to evaluate the predictive performance of the ROX index, modified ROX index, and HACOR score for the need for invasive mechanical ventilation in adult intensive care unit patients with acute respiratory failure.
Patients receiving high-flow nasal oxygen (HFNO), noninvasive ventilation (NIV), or sequential HFNO and NIV will be included. Patients will be followed for 24 hours, and clinical and laboratory parameters will be recorded at baseline and at 2, 6, 12, and 24 hours.
The predictive performance of these indices and their changes over time will be evaluated according to respiratory support modality and type of respiratory failure.
No additional diagnostic or therapeutic interventions will be performed as part of the study. All treatment decisions will be made by the attending clinicians according to routine clinical practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 8 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HFNO Group | – | –Patients with acute respiratory failure receiving high-flow nasal oxygen as their respiratory support modality. |
| NIV Group | – | –Patients with acute respiratory failure receiving noninvasive ventilation as their respiratory support modality. |
| Sequential HFNO-NIV Group | – | –Patients receiving sequential or alternating high-flow nasal oxygen and noninvasive ventilation during the first 24 hours of intensive care follow-up. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of adult patients aged 18 years or older admitted to the tertiary-level Anesthesiology and Reanimation Intensive Care Units of Ankara Ataturk Sanatorium Training and Research Hospital with acute respiratory failure (Type I, Type II, or combined Type I-II) who receive high-flow nasal oxygen (HFNO), noninvasive ventilation (NIV), or sequential HFNO-NIV respiratory support. Eligible patients will be enrolled prospectively after obtaining informed consent from the patient or their legally authorized representative. Patients will be followed for 24 hours to evaluate the ability of ROX, modified ROX, and HACOR scores to predict the need for invasive mechanical ventilation. All respiratory support decisions will be made by the treating clinicians as part of routine clinical care, without any study-related intervention.
Key inclusion criteria (5 listed)
- Age 18 years or older.
- Diagnosis of acute respiratory failure.
- Type I, type II, or combined type I-II respiratory failure.
- Initiation of noninvasive respiratory support after admission to the intensive care unit.
- Written informed consent obtained from the patient or legally authorized representative.
Key exclusion criteria (6 listed)
- Patients admitted to the intensive care unit already intubated.
- Patients for whom immediate invasive mechanical ventilation is decided at the initial assessment.
- Patients undergoing cardiopulmonary resuscitation during follow-up.
- Patients with missing essential clinical data.
- Patients with type III or type IV respiratory failure.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Predictive Performance of the ROX Index for Invasive Mechanical Ventilation Requirement
Time frame: Within 24 hours of ICU admission.
The predictive performance of the baseline ROX index for the need for invasive mechanical ventilation within 24 hours of ICU admission will be assessed using receiver operating characteristic (ROC) curve analysis. The outcome will be reported as the area under the ROC curve (AUC), ranging from 0 to 1.
Predictive Performance of the Modified ROX Index for Invasive Mechanical Ventilation Requirement
Time frame: Within 24 hours of ICU admission.
The predictive performance of the baseline modified ROX index, calculated as (PaO2/FiO2)/respiratory rate, for the need for invasive mechanical ventilation within 24 hours of ICU admission will be assessed using ROC curve analysis. The outcome will be reported as the AUC, ranging from 0 to 1.
Predictive Performance of the HACOR Score for Invasive Mechanical Ventilation Requirement
Time frame: Within 24 hours of ICU admission.
The predictive performance of the baseline HACOR score, incorporating heart rate, acidosis, consciousness, oxygenation, and respiratory rate, for the need for invasive mechanical ventilation within 24 hours of ICU admission will be assessed using ROC curve analysis. The outcome will be reported as the AUC, ranging from 0 to 1.
5 secondary outcomes
Changes in ROX Score Over Time
Time frame: Baseline, 2, 6, 12, and 24 hours.
Changes in Modified ROX Score Over Time
Time frame: Baseline, 2, 6, 12, and 24 hours.
Changes in HACOR Score Over Time
Time frame: Baseline, 2, 6, 12, and 24 hours.
Predictive Performance According to Respiratory Support Modality
Time frame: Within 24 hours after intensive care admission.
Predictive Performance According to Respiratory Failure Type
Time frame: Within 24 hours after intensive care admission.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Results publication: PubMed 38360681Okano H, Yamamoto R, Iwasaki Y, Irimada D, Konno D, Tanaka T, Oishi T, Nawa H, Yano A, Taniguchi H, Otawara M, Matsuoka A, Yamauchi M. External validation of the HACOR score and ROX index for predicting treatment failure in patients with coronavirus disease 2019 pneumonia managed on high-flow nasal cannula therapy: a multicenter retrospective observational study in Japan. J Intensive Care. 2024 Feb 15;12(1):7. doi: 10.1186/s40560-024-00720-8.
- Results publication: PubMed 41776692Muhetaer Y, Zhang SM, Moming A, Liu K, Zhong M. Prediction of high-flow nasal cannula failure in critically ill patients: a narrative review. J Intensive Care. 2026 Mar 3;14(1):27. doi: 10.1186/s40560-026-00871-w.
- Results publication: PubMed 35365110Zhou X, Liu J, Pan J, Xu Z, Xu J. The ROX index as a predictor of high-flow nasal cannula outcome in pneumonia patients with acute hypoxemic respiratory failure: a systematic review and meta-analysis. BMC Pulm Med. 2022 Apr 1;22(1):121. doi: 10.1186/s12890-022-01914-2.
- 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.
GÜLER ERARSLAN DOGANAY principal investigator
ANKARA ATATURK SANATORYUM EDUCATION AND RESEARCH HOSPİTAL
Questions about this trial
What is this clinical trial studying?
An observational study of High Flow Oxygen Therapy and Non Invasive Ventilation (NIV), run by Ankara Ataturk Sanatorium Training and Research Hospital.
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 5 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: opening soon, as of the sponsor's last update on 27 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ASLAN MERT (+90-544-276-94-71, aslanmert95@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Predictive Performance of the ROX Index for Invasive Mechanical Ventilation Requirement (time frame: Within 24 hours of ICU admission.). The study lists 3 primary outcomes in all. 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 NCT07896616, 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 27 Oct 2026.