Respiratory InsufficiencyNCT04441736
Post -Extubation Respiratory Failure
A study testing High flow nasal cannula in people with Respiratory Insufficiency, run by Cairo University at 1 site in Egypt.
Trial summary
comparing high flow nasal cannula , conventional oxygen tharapy and non invasive ventilation post-extubation period for patients mechanically ventilated due to respiratory failure regarding re-intubation rate, ICU outcome \& 28 days mortality Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Respiratory Insufficiency
- What is being tested?
- High flow nasal cannula
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Feb 2019to 31 May 2020
- Phase
- Interventional
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- respiratory failure type I and Type II
Who cannot join
- Mechanical ventilation due to other cause such as disturbed conscious level or respiratory muscle weakness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Different Oxygenation Modalities for Early Post Extubation Failure
comparing high flow nasal cannula , conventional oxygen tharapy and non invasive ventilation post-extubation period for patients mechanically ventilated due to respiratory failure regarding re-intubation rate, ICU outcome \& 28 days mortality
Read the detailed description
patients with respiratory failure either type I or type II planned for extubation will be divided into 3 groups post extubation :
Group I: will receive high flow nasal cannula giving oxygen 60 litres / minute flow group II: will receive nasal cannula up to 10 litres / minute group III: will receive non invasive ventilation
Data of the patients will be collected for 28 days post-extubation and analysed
- Conditions
- Respiratory Insufficiency
- Being tested
- High flow nasal cannula
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High flow nasal cannulaDevice
Also called Non invasive ventilation
Device gives high flow oxygen comparable to non invasive ventilation and conventional oxygen therapy
| Study group | Role | What they receive |
|---|---|---|
| High flow nasal cannula | Active comparator | A device of high flow nasal cannula giving 60 litres / min flow Receives: Device: High flow nasal cannula |
| Conventional oxygen | Placebo comparator | Nasal cannula giving oxygen up to 10 litres / minute Receives: Device: High flow nasal cannula |
| Non invasive ventilation | Active comparator | non invasive ventilation with IPAP and EPAP Receives: Device: High flow nasal cannula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with post extubation respiratory failure
Number of participants with post extubation hypoxemia with or without hypercapnea
Measured: 7 days
Secondary outcomes (1)
Rate of ICU stay and mortality
Duration of ICU stay and incidence of mortality
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2020
- Study start20 Feb 2019
- Primary completion30 May 2020
- Study completion31 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory InsufficiencyStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa Farouk, Cairo University
- Investigators
- Yasser Nassar, MD, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04441736
- Sponsor's protocol ID
- MS-313-2019
- Status last verified
- May 2024
- First submitted
- 10 Jun 2020
- Last updated
- 31 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Different Oxygenation Modalities for Early Post Extubation Failure
- ClinicalTrials.gov ID
- NCT04441736
- Acronym / sponsor ID
- MS-313-2019
- Conditions
- Respiratory Insufficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Feb 2019 (actual)
- Primary completion
- 30 May 2020 (actual)
- Study completion
- 31 May 2020 (actual)
- First posted
- 22 Jun 2020 (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.
comparing high flow nasal cannula , conventional oxygen tharapy and non invasive ventilation post-extubation period for patients mechanically ventilated due to respiratory failure regarding re-intubation rate, ICU outcome \& 28 days mortality
Detailed description
patients with respiratory failure either type I or type II planned for extubation will be divided into 3 groups post extubation :
Group I: will receive high flow nasal cannula giving oxygen 60 litres / minute flow group II: will receive nasal cannula up to 10 litres / minute group III: will receive non invasive ventilation
Data of the patients will be collected for 28 days post-extubation and analysed
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High flow nasal cannula | Active comparator | Device: High flow nasal cannulaA device of high flow nasal cannula giving 60 litres / min flow |
| Conventional oxygen | Placebo comparator | Device: High flow nasal cannulaNasal cannula giving oxygen up to 10 litres / minute |
| Non invasive ventilation | Active comparator | Device: High flow nasal cannulanon invasive ventilation with IPAP and EPAP |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- respiratory failure type I and Type II
Key exclusion criteria (1 listed)
- Mechanical ventilation due to other cause such as disturbed conscious level or respiratory muscle weakness
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 |
|---|---|---|
| High flow nasal cannulaAlso: Non invasive ventilationDevice gives high flow oxygen comparable to non invasive ventilation and conventional oxygen therapy | Device | Conventional oxygen, High flow nasal cannula, Non invasive ventilation |
Primary outcome
Number of participants with post extubation respiratory failure
Time frame: 7 days
Number of participants with post extubation hypoxemia with or without hypercapnea
1 secondary outcome
Rate of ICU stay and mortality
Time frame: 28 days
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 31 May 2024.
- Individual participant dataSharing planned: No
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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.
Yasser Nassar, MD principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High flow nasal cannula in people with Respiratory Insufficiency, run by Cairo 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 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 31 May 2024. 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. Some participants in this study may receive a placebo. 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?
Number of participants with post extubation respiratory failure (time frame: 7 days). 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 31 May 2024.