Rox IndexNCT05309239
ROX Index in Acute Respiratory Failure
An observational study of Rox Index, run by Assiut University at 1 site in Egypt.
Trial summary
evaluation of ROX index among ICU patients to evaluate the success of non invasive ventilation or the need for intubation Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Rox Index
- What is being tested?
- ROX index
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 21 Mar 2022to 1 Mar 2024
- How long will I take part?
- 5 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: patients administered in chest ICU in Assiut university hospital
Who may be able to join
- Participants admitted to RICU with type I and type II respiratory failure requiring NIV support with one or more of the following :
- PaO2/FiO2 less than or equal to 300 mmHg despite supplying oxygen at a flow rate ≥ to 10 l/min for ≥ 15 min
- Patients requiring ventilatory support due to increased respiratory rate ≥ 25 breaths/min or using accessory muscles of respiration
Who cannot join
- 1. Absolute indication for intubation like coma, hemodynamic instability, or life-threatening arrhythmia.
- 2. Contraindication to NIV like untreated pneumothorax, pneumothorax with air leak, widespread facial burn or trauma, tracheotomy,or active upper gastrointestinal bleeding.
- 3. Resusal to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Role of ROX Index as an Indicator for Non-invasive Ventilation in Acute Respiratory Failure
evaluation of ROX index among ICU patients to evaluate the success of non invasive ventilation or the need for intubation
- Conditions
- Rox Index
- Being tested
- ROX index
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ROX indexOther
observation of ROX index to evaluate the efficacy of non invasive ventilation
What is being measured
The primary outcome is the main question the study is designed to answer.
Success vs failure of non invasive ventilation
by ROX index calculation
Measured: within 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2022
- Study start21 Mar 2022
- Primary completion1 Apr 2023 (estimated)
- Study completion1 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rox IndexStudies 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
- 100 participants (estimated)
- Target duration
- 5 Days
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kholoud Zakaria, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05309239
- Sponsor's protocol ID
- CHESTROX
- Status last verified
- Mar 2022
- First submitted
- 25 Mar 2022
- Last updated
- 4 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of ROX Index as an Indicator for Non-invasive Ventilation in Acute Respiratory Failure
- ClinicalTrials.gov ID
- NCT05309239
- Acronym / sponsor ID
- CHESTROX
- Conditions
- Rox Index
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 21 Mar 2022 (actual)
- Primary completion
- 1 Apr 2023 (estimated)
- Study completion
- 1 Mar 2024 (estimated)
- First posted
- 4 Apr 2022 (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.
evaluation of ROX index among ICU patients to evaluate the success of non invasive ventilation or the need for intubation
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Days
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- patients administered in chest ICU in Assiut university hospital
Key inclusion criteria (3 listed)
- Participants admitted to RICU with type I and type II respiratory failure requiring NIV support with one or more of the following :
Key exclusion criteria (3 listed)
- 1. Absolute indication for intubation like coma, hemodynamic instability, or life-threatening arrhythmia.
- 2. Contraindication to NIV like untreated pneumothorax, pneumothorax with air leak, widespread facial burn or trauma, tracheotomy,or active upper gastrointestinal bleeding.
- 3. Resusal to participate in 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 indexobservation of ROX index to evaluate the efficacy of non invasive ventilation | Other | – |
Primary outcome
Success vs failure of non invasive ventilation
Time frame: within 6 months
by ROX index calculation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2022.
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Preoperative ROX Index for Predicting Early Postoperative Hypoxemia in ENT Surgery
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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.
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 Rox Index, run by Assiut University at 1 site in Egypt.
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 3 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: status not confirmed, as of the sponsor's last update on 4 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kholoud zakaria mahmoud, Master (01024529525, kholoudzakaria9@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success vs failure of non invasive ventilation (time frame: within 6 months). 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 Apr 2022.