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

NCT ID: NCT02515786

Last Updated: 2015-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2015-12-31

Brief Summary

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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

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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.

Conditions

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Chronic Respiratory Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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oxygen humidification

Oxygen by nasal catheter delivery will be humidified by bubles.

Group Type EXPERIMENTAL

oxygen humidification

Intervention Type OTHER

humidification for oxygen delivered by nasal catheter

Dry oxygen

oxygen by nasal catheter delivery will be dry

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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oxygen humidification

humidification for oxygen delivered by nasal catheter

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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Naomi Kondo Nakagawa

Associate Professor of Physiotherapy

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Paulo HN Saldiva, Professor

Role: STUDY_CHAIR

School of Medicine University of Sao Paulo

Naomi K Nakagawa, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

School of Medicine University of Sao Paulo

Locations

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School of Medicine University of Sao Paulo

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type DERIVED
PMID: 27048871 (View on PubMed)

Other Identifiers

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CEP 041/13

Identifier Type: -

Identifier Source: org_study_id