Weaning FailureNCT03505814
Interest of High Flow Nasal Cannula Oxygen Therapy in Pediatric Intensive Care Unit
A study testing High Flow Nasal Cannula Oxygen therapy (OPTIFLOW®) and Conventional oxygen therapy in people with Weaning Failure, run by Hôpital d'enfants Béchir-Hamza at 1 site in Tunisia.
Trial summary
monocentric randomized controlled trial starting from Mars 2017, recruitment is still ongoing. Patients aged between 0-45 days needing mechanical ventilation (MV) with tracheal intubation were included random assignation in two groups for post-extubation management: Group Optiflow (GO) for patients receiving High Flow… Read more about this study
- Who is it for?
- Ages 1 day to 45 days
- Conditions the study is for
- Weaning Failure
- What is being tested?
- High Flow Nasal Cannula Oxygen therapy (OPTIFLOW®) and Conventional oxygen therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteTunisia
- Study dates
- 1 Mar 2017to 28 Feb 2019
- 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 1 day to 45 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- need for mechanical ventilation
- tracheal intubation
- surgical intensive care admission
- availability of extubation criteria
Who cannot join
- prior extubation and mechanical ventilation to the actual episode
- weaning failure due to neurological status
Trial locations and contacts
1 site in 1 country.
Tunisia1 site, 1 recruiting
- Recruiting
Hopital d'Enfants Bechir Hamza
Tunis, 1029
Benkhalifa Sonia, Pr, 0021698360939, benkhalifa_sonia@yahoo.fr
About this study
Official title: Does High Flow Nasal Cannula Oxygen Therapy Prevent Reintubation in Pediatric Surgical Intensive Care Unit
monocentric randomized controlled trial starting from Mars 2017, recruitment is still ongoing. Patients aged between 0-45 days needing mechanical ventilation (MV) with tracheal intubation were included random assignation in two groups for post-extubation management: Group Optiflow (GO) for patients receiving High Flow Nasal Cannula Oxygen Therapy HNFC and Control Group (CG) for conventional treatment.
Patients were evaluated during the first 72h following extubation. Primary endpoint was the incidence of reintubation. Secondary endpoints were incidence of post-extubation respiratory failure, time to reintubate and weaning time from oxygen. Respiratory and hemodynamic parameters were assessed and compared between the two groups upon extubation, after 2 hours (H2), at H6, H12, H24, H36, H48 and H72. Length of stay (LOS) and mortality were also estimated.
Read the detailed description
We conducted a monocentric randomized controlled trial starting from Mars 2017, recruitment is still ongoing. Patients aged between 0-45 days needing mechanical ventilation (MV) with tracheal intubation were included regardless type of admission, severity of disease and randomly assigned in two groups for post-extubation management: Group Optiflow (GO) for patients receiving HNFC oxygen therapy and Control Group (CG) for conventional treatment. Before programmed extubation, newborns and young infants received 0.15 mg/kg of Dexamethasone. Patients were evaluated during the first 72h following extubation. Primary endpoint was the incidence of reintubation. Secondary endpoints were incidence of post-extubation respiratory failure, time to reintubate and weaning time from oxygen. Respiratory and hemodynamic parameters were assessed and compared between the two groups upon extubation, after 2 hours (H2), at H6, H12, H24, H36, H48 and H72. Length of stay (LOS) and mortality were also estimated.
- Conditions
- Weaning Failure
- Being tested
- High Flow Nasal Cannula Oxygen therapy (OPTIFLOW®), Conventional oxygen therapy
- Keywords
- post extubation care, neonatal surgical critical care, oxygen therapy, high nasal flow cannula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Flow Nasal Cannula Oxygen therapy (OPTIFLOW®)Device
High flow and humidified oxygen support for new borns and young infants for post-extubation care
Conventional oxygen therapyDevice
conventional oxygen support for new born and young infants in post-extubation care
| Study group | Role | What they receive |
|---|---|---|
| Optiflow Group | Experimental | high flow (6l/min), humidified oxygen administred into nasal cannula for post-extubation new born ventilated patients. Receives: Device: High Flow Nasal Cannula Oxygen therapy (OPTIFLOW®) |
| Control Group | Active comparator | Conventional oxygen therapy for post extubation care Receives: Device: Conventional oxygen therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
reintubation rate
need for mechanical ventilation support with tracheal intubation
Measured: 72 hours following prior weaning and extubation
Secondary outcomes (7)
incidence of post-extubation respiratory failure
respiratory failure
Measured: 72 hours following prior weaning and extubation
time to reintubate
time between first extubation and reintubation
Measured: 72 hours following prior weaning and extubation
weaning time from oxygen.
time to wean from any oxygen supply
Measured: 72 hours following prior weaning and extubation
blood pressure
blood pressure
Measured: 72 hours following prior weaning and extubation
heart rate
heart rate
Measured: 72 hours following prior weaning and extubation
respiratory rate
respiratory rate
Measured: 72 hours following prior weaning and extubation
SpO2/FiO2
pulsed oxygen saturation and inspired fraction of oxygen ratio
Measured: 72 hours following prior weaning and extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2018
- Study start1 Mar 2017
- Primary completion31 Aug 2018 (estimated)
- Study completion28 Feb 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weaning 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hôpital d'enfants Béchir-Hamza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Sonia ben khalifa (PhD), Hôpital d'enfants Béchir-Hamza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03505814
- Sponsor's protocol ID
- HEBechirHamza
- Status last verified
- Apr 2018
- First submitted
- 3 Apr 2018
- Last updated
- 23 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does High Flow Nasal Cannula Oxygen Therapy Prevent Reintubation in Pediatric Surgical Intensive Care Unit
- ClinicalTrials.gov ID
- NCT03505814
- Acronym / sponsor ID
- HEBechirHamza
- Conditions
- Weaning Failure
- Keywords
- post extubation care, neonatal surgical critical care, oxygen therapy, high nasal flow cannula
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Hôpital d'enfants Béchir-HamzaUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 31 Aug 2018 (estimated)
- Study completion
- 28 Feb 2019 (estimated)
- First posted
- 23 Apr 2018 (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.
monocentric randomized controlled trial starting from Mars 2017, recruitment is still ongoing. Patients aged between 0-45 days needing mechanical ventilation (MV) with tracheal intubation were included random assignation in two groups for post-extubation management: Group Optiflow (GO) for patients receiving High Flow Nasal Cannula Oxygen Therapy HNFC and Control Group (CG) for conventional treatment.
Patients were evaluated during the first 72h following extubation. Primary endpoint was the incidence of reintubation. Secondary endpoints were incidence of post-extubation respiratory failure, time to reintubate and weaning time from oxygen. Respiratory and hemodynamic parameters were assessed and compared between the two groups upon extubation, after 2 hours (H2), at H6, H12, H24, H36, H48 and H72. Length of stay (LOS) and mortality were also estimated.
Detailed description
We conducted a monocentric randomized controlled trial starting from Mars 2017, recruitment is still ongoing. Patients aged between 0-45 days needing mechanical ventilation (MV) with tracheal intubation were included regardless type of admission, severity of disease and randomly assigned in two groups for post-extubation management: Group Optiflow (GO) for patients receiving HNFC oxygen therapy and Control Group (CG) for conventional treatment. Before programmed extubation, newborns and young infants received 0.15 mg/kg of Dexamethasone. Patients were evaluated during the first 72h following extubation. Primary endpoint was the incidence of reintubation. Secondary endpoints were incidence of post-extubation respiratory failure, time to reintubate and weaning time from oxygen. Respiratory and hemodynamic parameters were assessed and compared between the two groups upon extubation, after 2 hours (H2), at H6, H12, H24, H36, H48 and H72. Length of stay (LOS) and mortality were also estimated.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Optiflow Group | Experimental | Device: High Flow Nasal Cannula Oxygen therapy (OPTIFLOW®)high flow (6l/min), humidified oxygen administred into nasal cannula for post-extubation new born ventilated patients. |
| Control Group | Active comparator | Device: Conventional oxygen therapyConventional oxygen therapy for post extubation care |
Who may qualify
- Ages
- 1 day to 45 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- need for mechanical ventilation
- tracheal intubation
- surgical intensive care admission
- availability of extubation criteria
Key exclusion criteria (2 listed)
- prior extubation and mechanical ventilation to the actual episode
- weaning failure due to neurological status
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 Cannula Oxygen therapy (OPTIFLOW®)High flow and humidified oxygen support for new borns and young infants for post-extubation care | Device | Optiflow Group |
| Conventional oxygen therapyconventional oxygen support for new born and young infants in post-extubation care | Device | Control Group |
Primary outcome
reintubation rate
Time frame: 72 hours following prior weaning and extubation
need for mechanical ventilation support with tracheal intubation
7 secondary outcomes
incidence of post-extubation respiratory failure
Time frame: 72 hours following prior weaning and extubation
time to reintubate
Time frame: 72 hours following prior weaning and extubation
weaning time from oxygen.
Time frame: 72 hours following prior weaning and extubation
blood pressure
Time frame: 72 hours following prior weaning and extubation
heart rate
Time frame: 72 hours following prior weaning and extubation
respiratory rate
Time frame: 72 hours following prior weaning and extubation
SpO2/FiO2
Time frame: 72 hours following prior weaning and extubation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2018.
- Individual participant dataSharing planned: Undecided
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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?
A study testing High Flow Nasal Cannula Oxygen therapy (OPTIFLOW®) and Conventional oxygen therapy in people with Weaning Failure, run by Hôpital d'enfants Béchir-Hamza 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 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 23 Apr 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ben Khalifa Sonia, Pr (0021698360939, benkhalifa_sonia@yahoo.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
reintubation rate (time frame: 72 hours following prior weaning and extubation). 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 23 Apr 2018.