Cystic FibrosisHIFLOWCFNCT01810536
High Flow Nasal Oxygen for Children With Cystic Fibrosis Presenting With Respiratory Failure - a Randomized Controlled Study
A study testing Hi-flow nasal cannula and Venturi mask in people with Cystic Fibrosis, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
Respiratory exacerbations are frequent among cystic fibrosis patients and supplemental oxygen is usually required. We will compare a new high flow nasal cannula system with Venturi masks for oxygen supplementation to patients with CF hospitalized for respiratory exacerbation. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Hi-flow nasal cannula and Venturi mask
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteBrazil
- Study dates
- Apr 2013to May 2016
- 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 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Established diagnosis of cystic fibrosis
- Age between 6 and 17 years
- Ability to perform lung function testing
- Hospital admission due to acute pulmonary exacerbation in the last 12h
- Regular use of Pulmozyme
- Need for high FiO2 defined as more than 2 liters per minute in the nasal cannula or need of a Venturi mask
Who cannot join
- Recent admission (less than 30 days)
- Recent or current atelectasis (less than 3 months)
- Hemoptysis or pneumothorax
- Need for a bronchoscopy during admission
- Need for non-invasive ventilation for more than 2 hours/day
Trial locations and contacts
1 site in 1 country.
About this study
Respiratory exacerbations are frequent among cystic fibrosis patients and supplemental oxygen is usually required. We will compare a new high flow nasal cannula system with Venturi masks for oxygen supplementation to patients with CF hospitalized for respiratory exacerbation.
Read the detailed description
Introduction: Cystic fibrosis (CF) is a genetic disease that leads to chronic lung infections and recurrent respiratory exacerbations. Supplemental oxygen is usually required during respiratory exacerbations. Recently, a new high flow nasal cannula system that provides flows up to 40l/min at 100% humidification was developed and tested in neonates and children, providing greater comfort to the patient. The main hypothesis of the study is that this method has advantages for oxygen supplementation to patients with CF hospitalized for respiratory exacerbation. Methods: 40 patients with CF aged 6 to 18 years will be randomized to receive supplemental oxygen via nasal cannula or Venturi masks during hospitalization for respiratory exacerbation. Main outcomes will be the duration of hospitalization and oxygen supplementation, viscosity and transportability of sputum and personal impressions of patients regarding the method of oxygen administration (questionnaire). Spirometry and venous blood gas analysis will be performed after the second hospital day, and sputum samples will be obtained in the first and third day of hospitalization. Clinical treatment (antibiotics, etc) will be defined by the medical team of the institution, not involved in the study. Expected Results: The use of high flow nasal cannula will result in significantly less time of supplemental oxygen, with increased comfort for patients, without significant differences in the levels of PaCO2. Sputum samples obtained from the patients treated with the high flow nasal cannula will have lower viscosity and higher transportability as compared to those obtained from patients treated with Venturi mask.
- Conditions
- Cystic Fibrosis
- Being tested
- Hi-flow nasal cannula, Venturi mask
- Keywords
- Cystic fibrosis, oxygen, respiratory failure
- Medical subject headings
- Cystic Fibrosis, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hi-flow nasal cannulaDevice
Also called Optiflow, MaxVenturi
Different ways of providing supplemental oxygen will be compared: hi-flow nasal cannulas versus Venturi masks
Venturi maskDevice
| Study group | Role | What they receive |
|---|---|---|
| Hi-flow nasal cannula | Experimental | This group will receive supplemental oxygen by nasal cannula using the Optiflow system, with high flows of 100% humidified oxygen Receives: Device: Hi-flow nasal cannula |
| Venturi mask | Active comparator | This group will receive supplemental oxygen by the current standard in our Institution: Venturi masks Receives: Device: Venturi mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygen supplementation period
Since most CF patients admitted due to a respiratory exacerbation need supplemental oxygen for up to 96h, we aim at a reduction of at least 12h in this period.
Measured: up to 14 days
Secondary outcomes (1)
Days in the hospital
Measured: Up to 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2013 (estimated)
- Study startApr 2013
- Primary completionMay 2016
- Study completionMay 2016
Why it stopped: It was impossible for us to include patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luiz Vicente Ribeiro Ferreira da Silva Filho, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01810536
- Sponsor's protocol ID
- HIFLOWCF
- Acronym
- HIFLOWCF
- Status last verified
- Jul 2017
- First submitted
- 8 Mar 2013
- Last updated
- 5 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Flow Nasal Oxygen for Children With Cystic Fibrosis Presenting With Respiratory Failure - a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT01810536
- Acronym / sponsor ID
- HIFLOWCF / HIFLOWCF
- Conditions
- Cystic Fibrosis
- Keywords
- Cystic fibrosis, oxygen, respiratory failure
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: It was impossible for us to include patients
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 13 Mar 2013 (estimated)
- 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.
Respiratory exacerbations are frequent among cystic fibrosis patients and supplemental oxygen is usually required. We will compare a new high flow nasal cannula system with Venturi masks for oxygen supplementation to patients with CF hospitalized for respiratory exacerbation.
Detailed description
Introduction: Cystic fibrosis (CF) is a genetic disease that leads to chronic lung infections and recurrent respiratory exacerbations. Supplemental oxygen is usually required during respiratory exacerbations. Recently, a new high flow nasal cannula system that provides flows up to 40l/min at 100% humidification was developed and tested in neonates and children, providing greater comfort to the patient. The main hypothesis of the study is that this method has advantages for oxygen supplementation to patients with CF hospitalized for respiratory exacerbation. Methods: 40 patients with CF aged 6 to 18 years will be randomized to receive supplemental oxygen via nasal cannula or Venturi masks during hospitalization for respiratory exacerbation. Main outcomes will be the duration of hospitalization and oxygen supplementation, viscosity and transportability of sputum and personal impressions of patients regarding the method of oxygen administration (questionnaire). Spirometry and venous blood gas analysis will be performed after the second hospital day, and sputum samples will be obtained in the first and third day of hospitalization. Clinical treatment (antibiotics, etc) will be defined by the medical team of the institution, not involved in the study. Expected Results: The use of high flow nasal cannula will result in significantly less time of supplemental oxygen, with increased comfort for patients, without significant differences in the levels of PaCO2. Sputum samples obtained from the patients treated with the high flow nasal cannula will have lower viscosity and higher transportability as compared to those obtained from patients treated with Venturi mask.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hi-flow nasal cannula | Experimental | Device: Hi-flow nasal cannulaThis group will receive supplemental oxygen by nasal cannula using the Optiflow system, with high flows of 100% humidified oxygen |
| Venturi mask | Active comparator | Device: Venturi maskThis group will receive supplemental oxygen by the current standard in our Institution: Venturi masks |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Established diagnosis of cystic fibrosis
- Age between 6 and 17 years
- Ability to perform lung function testing
- Hospital admission due to acute pulmonary exacerbation in the last 12h
- Regular use of Pulmozyme
Key exclusion criteria (5 listed)
- Recent admission (less than 30 days)
- Recent or current atelectasis (less than 3 months)
- Hemoptysis or pneumothorax
- Need for a bronchoscopy during admission
- Need for non-invasive ventilation for more than 2 hours/day
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 |
|---|---|---|
| Hi-flow nasal cannulaAlso: Optiflow, MaxVenturiDifferent ways of providing supplemental oxygen will be compared: hi-flow nasal cannulas versus Venturi masks | Device | Hi-flow nasal cannula |
| Venturi mask | Device | Venturi mask |
Primary outcome
Oxygen supplementation period
Time frame: up to 14 days
Since most CF patients admitted due to a respiratory exacerbation need supplemental oxygen for up to 96h, we aim at a reduction of at least 12h in this period.
1 secondary outcome
Days in the hospital
Time frame: Up to 14 days
Results and safety
The study was stopped early (reason given: It was impossible for us to include patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hi-flow nasal cannula and Venturi mask in people with Cystic Fibrosis, run by University of Sao Paulo at 1 site in Brazil.
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 6 inclusion and 5 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: stopped early, as of the sponsor's last update on 5 Jul 2017. 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 Brazil. 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 was stopped early (reason given: It was impossible for us to include patients). 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?
Oxygen supplementation period (time frame: up to 14 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 5 Jul 2017.