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

NCT02515786 | Unknown Phase 1

• 1 other identifier: CEP 041/13
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Respiratory Failure

Keywords

Chronic respiratory failure; Oxygen therapy; Nasal catheter; Mucociliary clearance

Outcome Measures

Primary Outcomes (1)

• 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.

  First baseline measurement, 12 hours, 7 days, 30 days, 12 months and 24 months of use of home oxygen therapy

Other Outcomes (3)

• Analysis of Contact Angle of Mucus

  First baseline measurement, 12 hours, 7 days, 30 days, 12 months and 24 months of use of home oxygen therapy

• inflammation in the upper airway by analysis of nasal lavage

  First baseline measurement, 12 hours, 7 days, 30 days, 12 months and 24 months. of use of home oxygen therapy

• Upper airways symptoms by SNOT20 questionnaire

  First baseline measurement, 12 hours, 7 days, 30 days, 12 months and 24 months of use of home oxygen therapy

Study Arms (2)

oxygen humidification

EXPERIMENTAL

Oxygen by nasal catheter delivery will be humidified by bubles.

Other: oxygen humidification

Dry oxygen

NO INTERVENTION

oxygen by nasal catheter delivery will be dry

Interventions

oxygen humidification OTHER

humidification for oxygen delivered by nasal catheter

oxygen humidification

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• subjects aged ≥ 18 years with a medical indication for the use of home low-flow oxygen via nasal cannula

You may not qualify if:

• inability to taste saccharin
• nasal surgery
• infection in the last 30 days (before the study)

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

School of Medicine University of Sao Paulo

São Paulo, São Paulo, 0124-903, Brazil

Location

Related Publications (1)

• 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.

  PMID: 27048871 DERIVED

Study Officials

• Paulo HN Saldiva, Professor

  School of Medicine University of Sao Paulo

  STUDY CHAIR

• Naomi K Nakagawa, Ph.D.

  School of Medicine University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Physiotherapy

Study Record Dates

• First Submitted: May 26, 2015
• First Posted: August 5, 2015
• Study Start: January 1, 2013
• Primary Completion: July 1, 2015
• Study Completion: December 1, 2015
• Last Updated: November 24, 2015

Record last verified: 2015-11

Locations

BR (1)