Hypoxemic Respiratory FailureNCT04982341
HFNC and Prone Positioning in Awake Patients With Severe COVID-19
An observational study of Hypoxemic Respiratory Failure, run by Hôpital Universitaire Fattouma Bourguiba at 1 site in Tunisia.
Trial summary
The investigators evaluate the effects of High-flow nasal cannula (HFNC) in association with prone in patients with Covid-19 severe ARF. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hypoxemic Respiratory Failure
- What is being tested?
- prone position
- Type of treatment
- Surgery or procedure
- How many people
- 120 participants
- Where
- 1 siteTunisia
- Study dates
- 2 Sep 2020to 3 Mar 2021
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: Covid-19 confirmed by rtPCR, suffering from acute hypoxemic failure requiring oxygenation
Who may be able to join
- aged ≥18 years, admitted to the medical ICU for confirmed Covid-19 and acute hypoxemic respiratory failure
Who cannot join
- patients already intubated at admission or those requiring immediate intubation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of High-flow Nasal Cannula and Prone Positioning in Awake Patients With COVID-19 and Severe Acute Respiratory Failure
The investigators evaluate the effects of High-flow nasal cannula (HFNC) in association with prone in patients with Covid-19 severe ARF.
Read the detailed description
The investigators evaluate the effects of High-flow nasal cannula (HFNC) in association with prone in patients with Covid-19 severe ARF.
All patients with ARF related to Covid-19 and admitted to the ICU are turned in prone position whenever tolerated, while receiving oxygenation with HFNC.
Outcomes of interest are the rate of success or failure (defined as the need for intubation and mechanical ventilation)
- Conditions
- Hypoxemic Respiratory Failure
- Being tested
- prone position
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prone positionProcedure or surgery
patients are returned from prone to supine position while receiving oxygenation through HFNC
| Study group | Role | What they receive |
|---|---|---|
| HFNC/prone | awake patients with COVID-19 and severe acute respiratory failure receiving HFNC in prone position Receives: Procedure: prone position |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients without intubation
successful oxygenation without intubation
Measured: through study completion, an average of 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2021
- Study start2 Sep 2020
- Primary completion3 Mar 2021
- Study completion3 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypoxemic Respiratory FailureStudies 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
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital Universitaire Fattouma Bourguiba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fekri Abroug, Hôpital Universitaire Fattouma Bourguiba
- Investigators
- Lamia Besbes, Prof, Study chair, CPPRB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04982341
- Sponsor's protocol ID
- FattoumaBourguiba_HFNC_Prone
- Status last verified
- Jul 2021
- First submitted
- 19 Jul 2021
- Last updated
- 29 Jul 2021
- 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 29 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of High-flow Nasal Cannula and Prone Positioning in Awake Patients With COVID-19 and Severe Acute Respiratory Failure
- ClinicalTrials.gov ID
- NCT04982341
- Acronym / sponsor ID
- FattoumaBourguiba_HFNC_Prone
- Conditions
- Hypoxemic Respiratory Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Hôpital Universitaire Fattouma BourguibaUniversity, hospital or other
- Study start
- 2 Sep 2020 (actual)
- Primary completion
- 3 Mar 2021 (actual)
- Study completion
- 3 Mar 2021 (actual)
- First posted
- 29 Jul 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.
The investigators evaluate the effects of High-flow nasal cannula (HFNC) in association with prone in patients with Covid-19 severe ARF.
Detailed description
The investigators evaluate the effects of High-flow nasal cannula (HFNC) in association with prone in patients with Covid-19 severe ARF.
All patients with ARF related to Covid-19 and admitted to the ICU are turned in prone position whenever tolerated, while receiving oxygenation with HFNC.
Outcomes of interest are the rate of success or failure (defined as the need for intubation and mechanical ventilation)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HFNC/prone | – | Procedure: prone positionawake patients with COVID-19 and severe acute respiratory failure receiving HFNC in prone position |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Covid-19 confirmed by rtPCR, suffering from acute hypoxemic failure requiring oxygenation
Key inclusion criteria (1 listed)
- aged ≥18 years, admitted to the medical ICU for confirmed Covid-19 and acute hypoxemic respiratory failure
Key exclusion criteria (1 listed)
- patients already intubated at admission or those requiring immediate intubation
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 |
|---|---|---|
| prone positionpatients are returned from prone to supine position while receiving oxygenation through HFNC | Procedure or surgery | HFNC/prone |
Primary outcome
Number of patients without intubation
Time frame: through study completion, an average of 28 days
successful oxygenation without intubation
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 29 Jul 2021.
- 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.
Lamia Besbes, Prof study chair
CPPRB
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 Hypoxemic Respiratory Failure, run by Hôpital Universitaire Fattouma Bourguiba at 1 site in Tunisia.
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 29 Jul 2021. 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 Tunisia. 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?
Number of patients without intubation (time frame: through study completion, an average of 28 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 29 Jul 2021.