COVID-19 PneumoniaNCT05150886
The Validity of the ROX Index in Predicting Intubation in Patients With Covid-19 Pneumonia
An observational study of COVID-19 Pneumonia, run by Atatürk Chest Diseases and Chest Surgery Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
BACKGROUND: ROX index (SpO2 / FiO2) / respiratory rate, which is the ratio of peripheral oxygen saturation (SpO2) and inspired oxygen fraction (FiO2) divided by respiratory rate, to predict failure of HFNO therapy and intubation in patients with a rapid, easy-to-use, rapidly administered pneumonia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19 Pneumonia
- What is being tested?
- rox index
- How many people
- 137 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2022to 8 Apr 2022
- How long will I take part?
- 68 Days
- 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 admitted to the intensive care unit.
Who may be able to join
- Adult patients (≥18 years of age) with acute respiratory failure due to COVID-19 pneumonia, PCR positive in the nasopharyngeal swab, and HFNO on admission to the intensive care unit will be included in this study.
Who cannot join
- Patients under the age of 18 who received non-invasive or invasive mechanical ventilation therapy before HFNO will not be included in the study. Patients with chronic lung disease will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
BACKGROUND: ROX index (SpO2 / FiO2) / respiratory rate, which is the ratio of peripheral oxygen saturation (SpO2) and inspired oxygen fraction (FiO2) divided by respiratory rate, to predict failure of HFNO therapy and intubation in patients with a rapid, easy-to-use, rapidly administered pneumonia. index used not to delay. This is a rating. HFNO reduces the need for endotracheal intubation in patients with acute hypoxic respiratory failure due to pneumonia. It has been suggested that HFNO may reduce the need for invasive mechanical ventilation compared to conventional oxygen therapy. Recently, experience has been reported that HFNO therapy also reduces the need for endotracheal intubation in patients with COVID-19 pneumonia. However, there are studies showing that insisting on HFNO and delaying intubation increase mortality in patients with acute respiratory distress syndrome (ARDS) and acute respiratory failure. In this study; We aimed to investigate the validity of the ROX index in predicting HFNO failure in patients with COVID-19 pneumonia admitted to the intensive care unit.
Read the detailed description
BACKGROUND: ROX index (SpO2 / FiO2) / respiratory rate, which is the ratio of peripheral oxygen saturation (SpO2) and inspired oxygen fraction (FiO2) divided by respiratory rate, to predict failure of HFNO therapy and intubation in patients with a rapid, easy-to-use, rapidly administered pneumonia. index used not to delay. This is a rating. HFNO reduces the need for endotracheal intubation in patients with acute hypoxic respiratory failure due to pneumonia. It has been suggested that HFNO may reduce the need for invasive mechanical ventilation compared to conventional oxygen therapy. Recently, experience has been reported that HFNO therapy also reduces the need for endotracheal intubation in patients with COVID-19 pneumonia. However, there are studies showing that insisting on HFNO and delaying intubation increase mortality in patients with acute respiratory distress syndrome (ARDS) and acute respiratory failure. In this study; We aimed to investigate the validity of the ROX index in predicting HFNO failure in patients with COVID-19 pneumonia admitted to the intensive care unit.
MATERIAL - METHOD: The population of the research consists of patients who will be hospitalized in the COVID-19 intensive care unit of Health Sciences University Ankara Atatürk Chest Diseases and Thoracic Surgery Training and Research Hospital for 3 months. According to a study conducted in Italy, 87% of COVID-19 patients hospitalized in intensive care go to intubation (6). Adult patients (≥18 years old) with acute respiratory failure due to COVID-19 pneumonia, positive PCR on nasopharyngeal swab, and HFNO when admitted to the intensive care unit will be included in this study. Patients under the age of 18 who received non-invasive or invasive mechanical ventilation therapy before HFNO will not be included in the study. Patients with chronic lung disease will be excluded from the study. RT-PCR tests will be performed with serial samples for detection of viral RNA. Demographic, clinical, treatment and laboratory data of the patients will be recorded. ROX score, APACHE 2 scores, Pneumonia Severity Index (PSI) score, CURB-65 and SOFA score will be calculated and recorded. In addition, the day of hospitalization in the intensive care unit, intensive care and hospital mortality, intubation time, invasive mechanical ventilation day, time of exit from the intensive care unit and discharge from the hospital will be recorded.
ORGANİZATİON AND ANALYSİS OF RESEARCH DATA The sample number of the study was calculated with the OpenEpi online computer program. The number of samples calculated with α= 0.05, d=5 and 87% frequency in the 95% confidence interval is 122. SPSS 23.0 statistical package program will be used for statistical analysis of research data. As a statistical analysis, in the descriptive findings section, categorical variables will be presented as numbers and percentages, and continuous variables will be presented as mean±standard deviation (min-max) for data showing normal distribution and median (IQR; 25-75). For categorical variables for non-normally distributed data, whether there is a frequency difference between groups will be compared using appropriate chi-square tests. Continuous variables will be compared with the normal distribution using Student's t test or Mann-Whitney U test. ROC analysis will be performed to determine whether the ROX index has a good cut-off value in making the intubation decision of COVID-19 patients. Statistical significance level will be accepted as p<0.05.
- Conditions
- COVID-19 Pneumonia
- Being tested
- rox index
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rox indexDiagnostic test
After HFNC during reassessment, the ROX Index can help suggest which patients will fail HFNC and need to progress to intubation for further ventilatory support.
| Study group | Role | What they receive |
|---|---|---|
| Patients at low risk of intubation | Patients with a ROX index of 4.88 and above measured at the 12th hour of hospitalization in the intensive care unit. Receives: Diagnostic Test: rox index | |
| Patients at hihg risk of intubation | Patients with a ROX index of less than 4.88, measured at the 12th hour of admission to the intensive care unit. Receives: Diagnostic Test: rox index |
What is being measured
The primary outcome is the main question the study is designed to answer.
intubation
We aimed to investigate the validity of the ROX index in predicting HFNO failure in patients with COVID-19 pneumonia admitted to the intensive care unit.
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2021
- Study start1 Feb 2022
- Primary completion15 Mar 2022
- Study completion8 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 PneumoniaStudies 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
- 137 participants (actual)
- Target duration
- 68 Days
Sponsor and investigators
- Lead sponsor
- Atatürk Chest Diseases and Chest Surgery Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mesut DEMİRKÖSE, Atatürk Chest Diseases and Chest Surgery Training and Research Hospital
- Investigators
- MESUT DEMİRKÖSE, Principal investigator, university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05150886
- Sponsor's protocol ID
- 2012-KAEK-15/2434
- Status last verified
- Apr 2022
- First submitted
- 7 Dec 2021
- Last updated
- 15 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Validity of the ROX Index in Predicting Intubation in Patients with Covid-19 Pneumonia
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Validity of the ROX Index in Predicting Intubation in Patients With Covid-19 Pneumonia
- ClinicalTrials.gov ID
- NCT05150886
- Acronym / sponsor ID
- 2012-KAEK-15/2434
- Conditions
- COVID-19 Pneumonia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 137 participants (actual)
- Lead sponsor
- Atatürk Chest Diseases and Chest Surgery Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 15 Mar 2022 (actual)
- Study completion
- 8 Apr 2022 (actual)
- First posted
- 9 Dec 2021 (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.
BACKGROUND: ROX index (SpO2 / FiO2) / respiratory rate, which is the ratio of peripheral oxygen saturation (SpO2) and inspired oxygen fraction (FiO2) divided by respiratory rate, to predict failure of HFNO therapy and intubation in patients with a rapid, easy-to-use, rapidly administered pneumonia. index used not to delay. This is a rating. HFNO reduces the need for endotracheal intubation in patients with acute hypoxic respiratory failure due to pneumonia. It has been suggested that HFNO may reduce the need for invasive mechanical ventilation compared to conventional oxygen therapy. Recently, experience has been reported that HFNO therapy also reduces the need for endotracheal intubation in patients with COVID-19 pneumonia. However, there are studies showing that insisting on HFNO and delaying intubation increase mortality in patients with acute respiratory distress syndrome (ARDS) and acute respiratory failure. In this study; We aimed to investigate the validity of the ROX index in predicting HFNO failure in patients with COVID-19 pneumonia admitted to the intensive care unit.
Detailed description
BACKGROUND: ROX index (SpO2 / FiO2) / respiratory rate, which is the ratio of peripheral oxygen saturation (SpO2) and inspired oxygen fraction (FiO2) divided by respiratory rate, to predict failure of HFNO therapy and intubation in patients with a rapid, easy-to-use, rapidly administered pneumonia. index used not to delay. This is a rating. HFNO reduces the need for endotracheal intubation in patients with acute hypoxic respiratory failure due to pneumonia. It has been suggested that HFNO may reduce the need for invasive mechanical ventilation compared to conventional oxygen therapy. Recently, experience has been reported that HFNO therapy also reduces the need for endotracheal intubation in patients with COVID-19 pneumonia. However, there are studies showing that insisting on HFNO and delaying intubation increase mortality in patients with acute respiratory distress syndrome (ARDS) and acute respiratory failure. In this study; We aimed to investigate the validity of the ROX index in predicting HFNO failure in patients with COVID-19 pneumonia admitted to the intensive care unit.
MATERIAL - METHOD: The population of the research consists of patients who will be hospitalized in the COVID-19 intensive care unit of Health Sciences University Ankara Atatürk Chest Diseases and Thoracic Surgery Training and Research Hospital for 3 months. According to a study conducted in Italy, 87% of COVID-19 patients hospitalized in intensive care go to intubation (6). Adult patients (≥18 years old) with acute respiratory failure due to COVID-19 pneumonia, positive PCR on nasopharyngeal swab, and HFNO when admitted to the intensive care unit will be included in this study. Patients under the age of 18 who received non-invasive or invasive mechanical ventilation therapy before HFNO will not be included in the study. Patients with chronic lung disease will be excluded from the study. RT-PCR tests will be performed with serial samples for detection of viral RNA. Demographic, clinical, treatment and laboratory data of the patients will be recorded. ROX score, APACHE 2 scores, Pneumonia Severity Index (PSI) score, CURB-65 and SOFA score will be calculated and recorded. In addition, the day of hospitalization in the intensive care unit, intensive care and hospital mortality, intubation time, invasive mechanical ventilation day, time of exit from the intensive care unit and discharge from the hospital will be recorded.
ORGANİZATİON AND ANALYSİS OF RESEARCH DATA The sample number of the study was calculated with the OpenEpi online computer program. The number of samples calculated with α= 0.05, d=5 and 87% frequency in the 95% confidence interval is 122. SPSS 23.0 statistical package program will be used for statistical analysis of research data. As a statistical analysis, in the descriptive findings section, categorical variables will be presented as numbers and percentages, and continuous variables will be presented as mean±standard deviation (min-max) for data showing normal distribution and median (IQR; 25-75). For categorical variables for non-normally distributed data, whether there is a frequency difference between groups will be compared using appropriate chi-square tests. Continuous variables will be compared with the normal distribution using Student's t test or Mann-Whitney U test. ROC analysis will be performed to determine whether the ROX index has a good cut-off value in making the intubation decision of COVID-19 patients. Statistical significance level will be accepted as p<0.05.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 68 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients at low risk of intubation | – | Diagnostic Test: rox indexPatients with a ROX index of 4.88 and above measured at the 12th hour of hospitalization in the intensive care unit. |
| Patients at hihg risk of intubation | – | Diagnostic Test: rox indexPatients with a ROX index of less than 4.88, measured at the 12th hour of admission to the intensive care unit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to the intensive care unit.
Key inclusion criteria (1 listed)
- Adult patients (≥18 years of age) with acute respiratory failure due to COVID-19 pneumonia, PCR positive in the nasopharyngeal swab, and HFNO on admission to the intensive care unit will be included in this study.
Key exclusion criteria (1 listed)
- Patients under the age of 18 who received non-invasive or invasive mechanical ventilation therapy before HFNO will not be included in the study. Patients with chronic lung disease will be excluded from the study.
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 |
|---|---|---|
| rox indexAfter HFNC during reassessment, the ROX Index can help suggest which patients will fail HFNC and need to progress to intubation for further ventilatory support. | Diagnostic test | Patients at hihg risk of intubation, Patients at low risk of intubation |
Primary outcome
intubation
Time frame: 3 month
We aimed to investigate the validity of the ROX index in predicting HFNO failure in patients with COVID-19 pneumonia admitted to the intensive care unit.
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 Apr 2022.
- Individual participant dataSharing planned: Yes. The Validity of the ROX Index in Predicting Intubation in Patients with Covid-19 Pneumonia
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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.
MESUT DEMİRKÖSE principal investigator
university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 Pneumonia, run by Atatürk Chest Diseases and Chest Surgery Training and Research Hospital at 1 site in Turkey (Türkiye).
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 1 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 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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?
intubation (time frame: 3 month). 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 Apr 2022.