Respiratory FailureNCT06715644
ROX Index Versus MROX Index to Predict Treatment Outcome for High Flow Nasal Cannula And/or Noninvasive Ventilation in Patients with Respiratory Failure
An observational study of Respiratory Failure, run by Assiut University.
Trial summary
One of managing steps in respiratory failure is high flow nasal cannula (HFNC), but the exact time to turn to invasive machine ventilation (IMV) is necessarily being determined. Respiratory rate and oxygenation (ROX) index, defined as the ratio of oxygen saturation as measured by pulse oximetry (SO2)/ FiO2 to… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Respiratory Failure
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2025to 1 Feb 2027
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient diagnosed with acute type 1or 2 or chronic type 1or 2 respiratory failure.
Who may be able to join
- Adult patients of both sex aged between 18 to 80 years
- Patient diagnosed with acute type 1or 2 or chronic type 1or 2 respiratory failure.
- Patient for chest ICU admission
- Patient for HFNC and/ or Noninvasive mechanical ventilation.
Who cannot join
- Pediatric patients
- Pregnant females
- Patients who are for intubation on ICU admissionc.
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
One of managing steps in respiratory failure is high flow nasal cannula (HFNC), but the exact time to turn to invasive machine ventilation (IMV) is necessarily being determined. Respiratory rate and oxygenation (ROX) index, defined as the ratio of oxygen saturation as measured by pulse oximetry (SO2)/ FiO2 to respiratory rate (RR), is used to determine when to intubate the patients who are on HFNC and prevent the delayed intubation. Modified Respiratory rate and oxygenation (mROX), defined as (PaO2/ FiO2) / respiratory rate, is also used to point the time of intubation in case HFNC of patients with respiratory failure . The diagnostic and prognostic accuracy of both parameters are reported in previous papers, but the preference of them is under research. In this study, we aim to observe and compare the diagnostic accuracy between ROX and mROX in determine the time of invasive mechanical ventilation.
Read the detailed description
Respiratory Failure (RF) is a condition where there's insufficient oxygenation in the body tissue, whether acute, chronic or acute on chronic; occurring due to decreased oxygen or excessive carbon-dioxide in the blood . There are four types of respiratory failure; Hypoxemic respiratory failure (Type1), hypercapnic respiratory failure (Type2), ) . Causes of RF are varied and accounted for any abnormality related upper respiratory tract, lower respiratory tract, central and peripheral nervous system or muscles of respiration . However, in the last three decades, the most common causes of RF is acute myocardial infarction (AMI), acute respiratory distress syndrome (ARDS), RF related to corona virus (Covid-19) and acute exacerbation of chronic obstructive lung disease (COPD).
- Conditions
- Respiratory Failure
- Keywords
- ROX index, mROX index, high flow nasal cannula, noninvasive ventilation
- Medical subject headings
- Respiratory Insufficiency
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 |
|---|---|---|
| group 1 | patients with respiratory failure treated with high flow nasal cannula | |
| group 2 | patients with respiratory failure treated with noninvasive ventilation in |
What is being measured
The primary outcome is the main question the study is designed to answer.
diagnostic accuracy of ROX in determine the time of invasive mechanical ventilation.
Sensitivity and Specificity in determine the time of invasive mechanical ventilation.
Measured: baseline
Secondary outcomes (1)
diagnostic accuracy mROX index in determine the time of invasive mechanical ventilation.
Sensitivity and Specificity of mROX index in determine the time of invasive mechanical ventilation.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2024
- Study start1 Jan 2025 (estimated)
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory FailureStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esraa Ramadan Abd el rahman Ibraheim, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06715644
- Sponsor's protocol ID
- ROX mROX HFNC RF
- Status last verified
- Nov 2024
- First submitted
- 29 Nov 2024
- Last updated
- 4 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ROX Index Versus MROX Index to Predict Treatment Outcome for High Flow Nasal Cannula And/or Noninvasive Ventilation in Patients with Respiratory Failure
- ClinicalTrials.gov ID
- NCT06715644
- Acronym / sponsor ID
- ROX mROX HFNC RF
- Conditions
- Respiratory Failure
- Keywords
- ROX index, mROX index, high flow nasal cannula, noninvasive ventilation
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 4 Dec 2024 (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.
One of managing steps in respiratory failure is high flow nasal cannula (HFNC), but the exact time to turn to invasive machine ventilation (IMV) is necessarily being determined. Respiratory rate and oxygenation (ROX) index, defined as the ratio of oxygen saturation as measured by pulse oximetry (SO2)/ FiO2 to respiratory rate (RR), is used to determine when to intubate the patients who are on HFNC and prevent the delayed intubation. Modified Respiratory rate and oxygenation (mROX), defined as (PaO2/ FiO2) / respiratory rate, is also used to point the time of intubation in case HFNC of patients with respiratory failure . The diagnostic and prognostic accuracy of both parameters are reported in previous papers, but the preference of them is under research. In this study, we aim to observe and compare the diagnostic accuracy between ROX and mROX in determine the time of invasive mechanical ventilation.
Detailed description
Respiratory Failure (RF) is a condition where there's insufficient oxygenation in the body tissue, whether acute, chronic or acute on chronic; occurring due to decreased oxygen or excessive carbon-dioxide in the blood . There are four types of respiratory failure; Hypoxemic respiratory failure (Type1), hypercapnic respiratory failure (Type2), ) . Causes of RF are varied and accounted for any abnormality related upper respiratory tract, lower respiratory tract, central and peripheral nervous system or muscles of respiration . However, in the last three decades, the most common causes of RF is acute myocardial infarction (AMI), acute respiratory distress syndrome (ARDS), RF related to corona virus (Covid-19) and acute exacerbation of chronic obstructive lung disease (COPD).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group 1 | – | –patients with respiratory failure treated with high flow nasal cannula |
| group 2 | – | –patients with respiratory failure treated with noninvasive ventilation in |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient diagnosed with acute type 1or 2 or chronic type 1or 2 respiratory failure.
Key inclusion criteria (4 listed)
- Adult patients of both sex aged between 18 to 80 years
- Patient diagnosed with acute type 1or 2 or chronic type 1or 2 respiratory failure.
- Patient for chest ICU admission
- Patient for HFNC and/ or Noninvasive mechanical ventilation.
Key exclusion criteria (3 listed)
- Pediatric patients
- Pregnant females
- Patients who are for intubation on ICU admissionc.
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
diagnostic accuracy of ROX in determine the time of invasive mechanical ventilation.
Time frame: baseline
Sensitivity and Specificity in determine the time of invasive mechanical ventilation.
1 secondary outcome
diagnostic accuracy mROX index in determine the time of invasive mechanical ventilation.
Time frame: baseline
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 4 Dec 2024.
- Individual participant dataSharing planned: Undecided
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Smartphone Camera Measurement of Breathing-Related Heart Rate Variability Compared With ECG in Healthy Adults
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Mechanical Ventilator Adjustments and Patient Dyspnea
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Failure, run by Assiut University.
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 4 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: opening soon, as of the sponsor's last update on 4 Dec 2024. 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 Esraa Ramadan Abd el rahman Ibraheim, resident doctor (+201032164070, rmdanasra024@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
diagnostic accuracy of ROX in determine the time of invasive mechanical ventilation. (time frame: baseline). 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 4 Dec 2024.