This trial is active, not recruiting.

Condition chronic respiratory failure
Treatment oxygen humidification
Phase phase 1/phase 2
Sponsor University of Sao Paulo
Start date January 2013
End date July 2015
Trial size 19 participants
Trial identifier NCT02515786, CEP 041/13


During normal breathing, the upper and lower airways performs the priming of inspired gas: humidification, heating and filtering from nose to the bronchios for adequate gas exchange occurs in the lungs. Many patients with severe or advanced cardiopulmonary conditions (cystic fibrosis, chronic obstructive pulmonary disease, pulmonary hypertension, advanced heart failure among others) may develop chronic respiratory failure and require treatment with oxygen therapy. High fractions of inspired oxygen have been associated with deleterious effects on the nasal ciliary beating and nose mucociliary transport. At home assistance, the patient with chronic respiratory receives oxygen via nasal cannula to the patient has been applied with and without humidification, however, does not know the effects of these two types of dry and humidified administration on the mucosa of the nose, airways and lungs. The investigators will assess the subject in use of home oxygen therapy at baseline, 12 hours, 7 days 30 days, 12 months and 24 months.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Oxygen by nasal catheter delivery will be humidified by bubles.
oxygen humidification
humidification for oxygen delivered by nasal catheter
(No Intervention)
oxygen by nasal catheter delivery will be dry

Primary Outcomes

saccharin transit time test
time frame: First baseline measurement, 12 hours, 7 days, 30 days, 12 months and 24 months of use of home oxygen therapy

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - subjects aged ≥ 18 years with a medical indication for the use of home low-flow oxygen via nasal cannula Exclusion Criteria: - inability to taste saccharin - nasal surgery - infection in the last 30 days (before the study)

Additional Information

Official title Effects of Long-term Dry and Humidified Low-flow Oxygen Via Nasal Cannula on Nasal Mucociliary Clearance, Mucus Properties, Inflammation and Airway Symptoms in Patients
Principal investigator Naomi K Nakagawa, Ph.D.
Description After agreeing to the terms of informed consent, the individual will be admitted to the study. The objective of this study was to evaluate the effects of humidified oxygen and not humidified nasal catheter (12-24 hours/day) on the nasal epithelium of patients with chronic respiratory failure by non-invasive tests in 36 volunteers, of both sexes aged ≥ 18 years with a medical indication for the use of home oxygen via nasal cannula on: (1) nasal mucociliary transport through the saccharin test, (2) the physical properties of nasal mucus by simulated cough machine and contact angle, (3) cellularity via nasal and total count differential white blood cell nasal lavage, (4) ph nasal lavage and exhaled breath condensate (5) quantification of cytokines in nasal lavage and (6) quality of life questionnaire with rhinosinusitis (SNOT20). Assessments will be performed at baseline, 12 hours, 7 days, 30 days, 12 months and 24 months of use. Volunteers will be recruited from three Basic Health Supervision of Cathedral Health, City Health Department, City of São Paulo.
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by University of Sao Paulo.