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

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ClinicalTrials.gov Identifier: NCT01810536
Recruitment Status : Terminated (It was impossible for us to include patients)
First Posted : March 13, 2013
Last Update Posted : July 5, 2017
Sponsor:
Information provided by (Responsible Party):
Luiz Vicente Ribeiro Ferreira da Silva Filho, University of Sao Paulo

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.

Condition or disease Intervention/treatment Phase
Cystic Fibrosis Device: Hi-flow nasal cannula Device: Venturi mask Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: High Flow Nasal Oxygen for Children With Cystic Fibrosis Presenting With Respiratory Failure - a Randomized Controlled Study
Study Start Date : April 2013
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016


Arm Intervention/treatment
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
Different ways of providing supplemental oxygen will be compared: hi-flow nasal cannulas versus Venturi masks
Other Names:
  • Optiflow
  • MaxVenturi

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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Days in the hospital [ Time Frame: Up to 14 days ]

Other Outcome Measures:
  1. Time to recover the baseline forced expiratory volume in one second [ Time Frame: Up to 14 days ]
    return to the baseline (stable) FEV1



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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01810536


Locations
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Brazil
Instituto da Criança, Hospital das Clínicas da FMUSP
São Paulo, Brazil
Sponsors and Collaborators
University of Sao Paulo

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Responsible Party: Luiz Vicente Ribeiro Ferreira da Silva Filho, MD, PhD, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01810536     History of Changes
Other Study ID Numbers: HIFLOWCF
First Posted: March 13, 2013    Key Record Dates
Last Update Posted: July 5, 2017
Last Verified: July 2017
Keywords provided by Luiz Vicente Ribeiro Ferreira da Silva Filho, University of Sao Paulo:
Cystic fibrosis
oxygen
respiratory failure
Additional relevant MeSH terms:
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Cystic Fibrosis
Respiratory Insufficiency
Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Respiration Disorders