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

Primary Purpose

Chronic Respiratory Failure

Status
Unknown status
Phase
Phase 1
Locations
Brazil
Study Type
Interventional
Intervention
oxygen humidification
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Respiratory Failure focused on measuring Chronic respiratory failure, Oxygen therapy, Nasal catheter, Mucociliary clearance

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • School of Medicine University of Sao Paulo

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

oxygen humidification

Dry oxygen

Arm Description

Oxygen by nasal catheter delivery will be humidified by bubles.

oxygen by nasal catheter delivery will be dry

Outcomes

Primary Outcome Measures

saccharin transit time test
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

Full Information

First Posted
May 26, 2015
Last Updated
November 23, 2015
Sponsor
University of Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT02515786
Brief Title
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

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Unknown status
Study Start Date
January 2013 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Respiratory Failure
Keywords
Chronic respiratory failure, Oxygen therapy, Nasal catheter, Mucociliary clearance

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
19 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
oxygen humidification
Arm Type
Experimental
Arm Description
Oxygen by nasal catheter delivery will be humidified by bubles.
Arm Title
Dry oxygen
Arm Type
No Intervention
Arm Description
oxygen by nasal catheter delivery will be dry
Intervention Type
Other
Intervention Name(s)
oxygen humidification
Intervention Description
humidification for oxygen delivered by nasal catheter
Primary Outcome Measure Information:
Title
saccharin transit time test
Description
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.
Time Frame
First baseline measurement, 12 hours, 7 days, 30 days, 12 months and 24 months of use of home oxygen therapy
Other Pre-specified Outcome Measures:
Title
Analysis of Contact Angle of Mucus
Description
In addition to the rheological properties of mucus, which imply on deformation and flow properties, and other characteristics as adhesiveness "wettabilidade" represents relevant physical properties in mucus transport by the cilia and cough . All biological fluid has the property of spreading when placed on a solid surface. As higher contact angle, lower is the "wettabilidade". Furthermore, the contact angle gives an inference adhesiveness, because the adhesion between the solid surface and specific mucus reflects the surface tension of the mucus and its contact angle. The contact angle is the angle formed between the tangent of the air-fluid interface and horizontal. The apparatus for measuring the contact angle is formed by a magnifying glass with hinged arm to move it laterally, forward and back. The magnifying glass has increased 25 times, with an eye that has a goniometer . The slide glass on which is deposited the
Time Frame
First baseline measurement, 12 hours, 7 days, 30 days, 12 months and 24 months of use of home oxygen therapy
Title
inflammation in the upper airway by analysis of nasal lavage
Description
Celularity and determination of IFN-α, IL-8, IL-10 and EGF (multiplex bead assay and ELISA) in nasal lavage. Celularity: the cell pellet is resuspended in one milliliter of phosphate buffer saline solution (PBS). Thereafter, 20 µl of the mixed solution is added to a Neubauer chamber, and the cells are counted using a 400x light microscope (Olympus CH2, Olympus America Inc., Palo Alto, USA). For differential cell counts, 100 µl of the mixed solution is centrifuged (96 g, 25°C, 6 min) to obtain a slide with two areas of cells that are stained with hematoxylin and eosin. Differential cell counts are performed with the aid of a 1000x light microscope (Olympus CH2, Olympus America Inc., Palo Alto, USA) by two different observers.
Time Frame
First baseline measurement, 12 hours, 7 days, 30 days, 12 months and 24 months. of use of home oxygen therapy
Title
Upper airways symptoms by SNOT20 questionnaire
Description
This is a questionnaire that aims to assess quality of life of patients with chronic upper airways symptoms
Time Frame
First baseline measurement, 12 hours, 7 days, 30 days, 12 months and 24 months of use of home oxygen therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paulo HN Saldiva, Professor
Organizational Affiliation
School of Medicine University of Sao Paulo
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Naomi K Nakagawa, Ph.D.
Organizational Affiliation
School of Medicine University of Sao Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
School of Medicine University of Sao Paulo
City
Sao Paulo
ZIP/Postal Code
0124-903
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
27048871
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.
Results Reference
derived

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

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