Effects of Long-term Dry and Humidified Low-flow Oxygen Via Nasal Cannula
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|ClinicalTrials.gov Identifier: NCT02515786|
Recruitment Status : Unknown
Verified November 2015 by Naomi Kondo Nakagawa, University of Sao Paulo.
Recruitment status was: Active, not recruiting
First Posted : August 5, 2015
Last Update Posted : November 24, 2015
|Condition or disease||Intervention/treatment||Phase|
|Chronic Respiratory Failure||Other: oxygen humidification||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||19 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||January 2013|
|Actual Primary Completion Date :||July 2015|
|Estimated Study Completion Date :||December 2015|
Experimental: oxygen humidification
Oxygen by nasal catheter delivery will be humidified by bubles.
Other: oxygen humidification
humidification for oxygen delivered by nasal catheter
No Intervention: Dry oxygen
oxygen by nasal catheter delivery will be dry
- 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 ]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.
- Analysis of Contact Angle of Mucus [ Time Frame: First baseline measurement, 12 hours, 7 days, 30 days, 12 months and 24 months of use of home oxygen therapy ]
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
- inflammation in the upper airway by analysis of nasal lavage [ Time Frame: First baseline measurement, 12 hours, 7 days, 30 days, 12 months and 24 months. of use of home oxygen therapy ]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.
- Upper airways symptoms by SNOT20 questionnaire [ Time Frame: First baseline measurement, 12 hours, 7 days, 30 days, 12 months and 24 months of use of home oxygen therapy ]This is a questionnaire that aims to assess quality of life of patients with chronic upper airways symptoms
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02515786
|School of Medicine University of Sao Paulo|
|Sao Paulo, Brazil, 0124-903|
|Study Chair:||Paulo HN Saldiva, Professor||School of Medicine University of Sao Paulo|
|Principal Investigator:||Naomi K Nakagawa, Ph.D.||School of Medicine University of Sao Paulo|