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
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.
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.
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 →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.
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Exclusion Criteria:
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
This group will receive supplemental oxygen by the current standard in our Institution: Venturi masks
Device: Venturi mask
Different ways of providing supplemental oxygen will be compared: hi-flow nasal cannulas versus Venturi masks
Also known as: Optiflow, MaxVenturi
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
Days in the hospital
Time frame: Up to 14 days
Time to recover the baseline forced expiratory volume in one second
return to the baseline (stable) FEV1
Time frame: Up to 14 days
This study is terminated, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.
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University of Sao Paulo