Clinical trial NCT02515786: Effects of Long-term Dry and Humidified Low-flow Oxygen Via Nasal Cannula
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Chronic Respiratory Failure
Keywords: Chronic respiratory failure
Oxygen therapy
Nasal catheter
Mucociliary clearance
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2015-08-05
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: saccharin transit time test
timeFrame: First baseline measurement, 12 hours, 7 days, 30 days, 12 months and 24 months of use of home oxygen therapy
Secondary outcomes:
Other outcomes:
measure: Analysis of Contact Angle of Mucus
timeFrame: First baseline measurement, 12 hours, 7 days, 30 days, 12 months and 24 months of use of home oxygen therapy
measure: inflammation in the upper airway by analysis of nasal lavage
timeFrame: First baseline measurement, 12 hours, 7 days, 30 days, 12 months and 24 months. of use of home oxygen therapy
measure: Upper airways symptoms by SNOT20 questionnaire
timeFrame: First baseline measurement, 12 hours, 7 days, 30 days, 12 months and 24 months of use of home oxygen therapy
Locations:
city: Sao Paulo
country: Brazil
facility: School of Medicine University of Sao Paulo
Study officials:
affiliation: School of Medicine University of Sao Paulo
name: Paulo HN Saldiva, Professor
role: STUDY_CHAIR
affiliation: School of Medicine University of Sao Paulo
name: Naomi K Nakagawa, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Franchini ML, Athanazio R, Amato-Lourenco LF, Carreirao-Neto W, Saldiva PH, Lorenzi-Filho G, Rubin BK, Nakagawa NK. Oxygen With Cold Bubble Humidification Is No Better Than Dry Oxygen in Preventing Mucus Dehydration, Decreased Mucociliary Clearance, and Decline in Pulmonary Function. Chest. 2016 Aug;150(2):407-14. doi: 10.1016/j.chest.2016.03.035. Epub 2016 Apr 2.