CClinicalTrials.gg
TerminatedNCT01810536HIFLOWCFUpdated Jul 5, 2017

High Flow Nasal Oxygen for Children With Cystic Fibrosis Presenting With Respiratory Failure - a Randomized Controlled Study

An interventional study of Hi-flow nasal cannula and Venturi mask in Cystic Fibrosis, sponsored by University of Sao Paulo. Terminated at 1 site in Brazil. Open to participants aged 6 Years to 17 Years. Per ClinicalTrials.gov, last updated 2017-07-05.

Sponsored by University of Sao Paulo · Not applicable, Interventional, and Treatment

Why this study was terminated
It was impossible for us to include patients
Phase
Not applicable
Study type
Interventional
Enrollment
4
Allocation
Randomized
Ages
6 Years to 17 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Cystic Fibrosis

Keywords

  • Cystic fibrosis
  • oxygen
  • respiratory failure
03

In context

Cystic Fibrosis

1,581 studies on the registry are indexed under Cystic Fibrosis; 190 are open to participants now.

This study's enrollment of 4 is below the median of 36 across 1,034 interventional studies indexed under Cystic Fibrosis.

Browse Cystic Fibrosis studies →

Lead sponsor

University of Sao Paulo is the lead sponsor of 1,005 studies on the registry; 90 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
4 participants (actual)

Study arms

  • Experimental
    Hi-flow nasal cannula

    This group will receive supplemental oxygen by nasal cannula using the Optiflow system, with high flows of 100% humidified oxygen

    Device: Hi-flow nasal cannula

  • Active comparator
    Venturi mask

    This group will receive supplemental oxygen by the current standard in our Institution: Venturi masks

    Device: Venturi mask

Interventions

  • DeviceHi-flow nasal cannula

    Different ways of providing supplemental oxygen will be compared: hi-flow nasal cannulas versus Venturi masks

    Also known as: Optiflow, MaxVenturi

  • DeviceVenturi mask
06

What researchers measure

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.

    Time frame: up to 14 days

Secondary outcomes

  1. Days in the hospital

    Time frame: Up to 14 days

Other outcomes

  1. Time to recover the baseline forced expiratory volume in one second

    return to the baseline (stable) FEV1

    Time frame: Up to 14 days

07

Study locations

1 site
  • Instituto da Criança, Hospital das Clínicas da FMUSP
    São Paulo, Brazil
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 5, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01810536
Lead sponsor
University of Sao Paulo
Responsible party
Luiz Vicente Ribeiro Ferreira da Silva Filho (MD, PhD, University of Sao Paulo) — Principal investigator
First posted
Mar 13, 2013
Start date
Apr 2013
Primary completion
May 2016
Completion
May 2016
Last update
Jul 5, 2017

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion