Acute Respiratory Failure Patients on NIV and HFNCNCT05864898
Predictors of Failure of Non-invasive Ventilation and High Flow Nasal Cannula
An observational study of Acute Respiratory Failure Patients on NIV and HFNC, run by Assiut University.
Trial summary
Comparison between some predictors of failure of non-invasive ventilation and high flow nasal cannula. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Failure Patients on NIV and HFNC
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2023to 1 Jul 2024
- 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
- Adult, Older adult
Study population: Patient in chest and Tuberculosis Departement, Assiut University
Who may be able to join
- Acute respiratory failure patients who need ventilatory Support either NIV or HFNC due to :
- RR > 25 cycle / min
- using accessory muscles and paradoxical breath.
- PaO2 / FiO2 ratio < 300
Who cannot join
- Absolute indication for intubation like coma, haemodynamically unstable… etc
- Contr-indication of NIV like untreated Pneumothorax.
About this study
Official title: Predictors of Failure of Non-invasive Ventilation and High Flow Nasal Cannula in Acute Respiratory Failure Patients : the Standardized PaO2 / FiO2 Ratio (P /F-st), ROX Index and HACOR
Comparison between some predictors of failure of non-invasive ventilation and high flow nasal cannula.
Read the detailed description
Delayed intubation after NIV / HFNC failure is associated with high mortality rate in acute respiratory failure patients.
There are Many factors to predict early failure but World still searching for new factors and comparing between each ;in order to eatablish best one that achieve the least mortality rate.
Little studies about effiecacy of HACOR Score as a predictor of failure in HFNC patients.
Little studies about effiecacy of ROX Index as a predictor of failure in NIV ventilating patients.
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine Golden time for intubation
Determine best time for intubation according to some predictors of failure of NIV and HFNC
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2023
- Study start1 Jul 2023 (estimated)
- Primary completion1 Apr 2024 (estimated)
- Study completion1 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory Failure Patients on NIV and HFNCStudies 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
- Cross-sectional
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hussein Makarem, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05864898
- Sponsor's protocol ID
- NIV and HFNC
- Status last verified
- May 2023
- First submitted
- 22 Mar 2023
- Last updated
- 18 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Failure of Non-invasive Ventilation and High Flow Nasal Cannula in Acute Respiratory Failure Patients : the Standardized PaO2 / FiO2 Ratio (P /F-st), ROX Index and HACOR
- ClinicalTrials.gov ID
- NCT05864898
- Acronym / sponsor ID
- NIV and HFNC
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jul 2023 (estimated)
- Primary completion
- 1 Apr 2024 (estimated)
- Study completion
- 1 Jul 2024 (estimated)
- First posted
- 18 May 2023 (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.
Comparison between some predictors of failure of non-invasive ventilation and high flow nasal cannula.
Detailed description
Delayed intubation after NIV / HFNC failure is associated with high mortality rate in acute respiratory failure patients.
There are Many factors to predict early failure but World still searching for new factors and comparing between each ;in order to eatablish best one that achieve the least mortality rate.
Little studies about effiecacy of HACOR Score as a predictor of failure in HFNC patients.
Little studies about effiecacy of ROX Index as a predictor of failure in NIV ventilating patients.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patient in chest and Tuberculosis Departement, Assiut University
Key inclusion criteria (4 listed)
- Acute respiratory failure patients who need ventilatory Support either NIV or HFNC due to :
- RR > 25 cycle / min
- using accessory muscles and paradoxical breath.
- PaO2 / FiO2 ratio < 300
Key exclusion criteria (2 listed)
- Absolute indication for intubation like coma, haemodynamically unstable… etc
- Contr-indication of NIV like untreated Pneumothorax.
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
Determine Golden time for intubation
Time frame: 1 year
Determine best time for intubation according to some predictors of failure of NIV and HFNC
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2023.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Respiratory Failure Patients on NIV and HFNC, 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 2 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 18 May 2023. 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?
Results are not available in the source record.
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?
Determine Golden time for intubation (time frame: 1 year). 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 18 May 2023.