Study Stopped
It was impossible for us to include patients
High Flow Nasal Oxygen for Children With Cystic Fibrosis Presenting With Respiratory Failure - a Randomized Controlled Study
HIFLOWCF
1 other identifier
interventional
4
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2013
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 8, 2013
CompletedFirst Posted
Study publicly available on registry
March 13, 2013
CompletedStudy Start
First participant enrolled
April 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2016
CompletedJuly 5, 2017
July 1, 2017
3.1 years
March 8, 2013
July 3, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
up to 14 days
Secondary Outcomes (1)
Days in the hospital
Up to 14 days
Other Outcomes (1)
Time to recover the baseline forced expiratory volume in one second
Up to 14 days
Study Arms (2)
Hi-flow nasal cannula
EXPERIMENTALThis group will receive supplemental oxygen by nasal cannula using the Optiflow system, with high flows of 100% humidified oxygen
Venturi mask
ACTIVE COMPARATORThis group will receive supplemental oxygen by the current standard in our Institution: Venturi masks
Interventions
Different ways of providing supplemental oxygen will be compared: hi-flow nasal cannulas versus Venturi masks
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Instituto da Criança, Hospital das Clínicas da FMUSP
São Paulo, Brazil
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
March 8, 2013
First Posted
March 13, 2013
Study Start
April 1, 2013
Primary Completion
May 1, 2016
Study Completion
May 1, 2016
Last Updated
July 5, 2017
Record last verified: 2017-07