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Effects of Long-term Dry and Humidified Low-flow Oxygen Via Nasal Cannula

Phase 1
Conditions
Chronic Respiratory Failure
Interventions
Other: oxygen humidification
Registration Number
NCT02515786
Lead Sponsor
University of Sao Paulo
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.

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
19
Inclusion Criteria
  • subjects aged ≥ 18 years with a medical indication for the use of home low-flow oxygen via nasal cannula
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Exclusion Criteria
  • inability to taste saccharin
  • nasal surgery
  • infection in the last 30 days (before the study)
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
oxygen humidificationoxygen humidificationOxygen by nasal catheter delivery will be humidified by bubles.
Primary Outcome Measures
NameTimeMethod
saccharin transit time testFirst baseline measurement, 12 hours, 7 days, 30 days, 12 months and 24 months of use of home oxygen therapy

The investigators evaluate the nasal MCC by measuring nasal saccharine transport time (STT). The subject is asked to avoid alcohol, tea and coffee for 6 hours and to eat or drink nothing for 2 hours before the measurements. The STT assessment is performed in a quiet room at a temperature of 21-22ºC and relative humidity of 63-71%. Subjects sat in a chair and are asked to maintain regular breathing, to avoid deep breathing, coughing, sneezing, sniffing or talking during STT measurements. Twenty-five µg saccharin particles are deposited 2 cm from the anterior end of the non-obstructed nostril and the timer is stopped at the first perception of sweet taste. The maximum delay between the deposition and perception is set at 60 minutes for non-detection.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

School of Medicine University of Sao Paulo

🇧🇷

Sao Paulo, Brazil

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