An observational study in High Flow Oxygen Therapy and Non Invasive Ventilation (NIV), sponsored by Ankara Ataturk Sanatorium Training and Research Hospital. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-27.
Sponsored by Ankara Ataturk Sanatorium Training and Research Hospital · Observational
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.
Ankara Ataturk Sanatorium Training and Research Hospital is the lead sponsor of 38 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with acute respiratory failure receiving high-flow nasal oxygen as their respiratory support modality.
Patients with acute respiratory failure receiving noninvasive ventilation as their respiratory support modality.
Patients receiving sequential or alternating high-flow nasal oxygen and noninvasive ventilation during the first 24 hours of intensive care follow-up.
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.
Time frame: 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.
Time frame: 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.
Time frame: Within 24 hours of ICU admission.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Within 24 hours after intensive care admission.
No study locations are listed for this record.
Plan to share: No
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Ankara Ataturk Sanatorium Training and Research Hospital