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Efficacy of Nasal High Flow therapy on the coordination between breathing and swallowing of saliva during daytime nap in COPD patients. A single center, randomized crossover controlled study.

Efficacy of Nasal High Flow therapy on the coordination between breathing and swallowing of saliva during daytime nap in COPD patients.

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Subjects: Thirty patients aged 40 years or older with chronic obstructive pulmonary disease (COPD) with a 1-second rate FEV1% value of less than 70% and stable symptoms requiring oxygen therapy, under treatment at the Department of Pulmonary Medicine and Pulmonary Rehabilitation, Nagasaki University Hospital, will be included. Chronic obstructive pulmonary disease (COPD) patients (GOLD stage 2 and stage 3 groups) with stable hypercarbonemia (arterial partial pressure of carbon dioxide (PaCO2 >45 Torr) and a history of COPD exacerbation (> moderate) within the past year and requiring home oxygen therapy will be included. In addition, patients who are able to salivate for at least 3 times/30 seconds during the repeated salivary swallow test (hereinafter referred to as "RSST") at the time of enrollment were included.

The target number of patients in this study was 15 cases (30 cases in total: 15 cases in each crossover group), Due to the patient environment, including coronary infections, patient enrollment was difficult and there was no final allocated enrollment, and the entire study was terminated with 0 cases.

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The number of patients enrolled was zero and did not reach the number of patients available for analysis.

Due to various influences, it was difficult to enroll and conduct patients in this study, but we believe that the clinical significance of the study is significant. We would like to develop a new implementation plan for the next study.

April. 30, 2025

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https://jrct.mhlw.go.jp/latest-detail/jRCTs072200014

Ayuse Takao

Nagasaki University Hospital

1-7-1 Sakamoto Nagasaki Japan

ayuse@nagasaki-u.ac.jp

Ayuse Takao

Nagasaki University Hospital

1-7-1 Sakamoto Nagasaki Japan

+81-958197713

ayuse@nagasaki-u.ac.jp

Complete

May. 21, 2020

Interventional

randomized controlled trial

open(masking not used)

no treatment control/standard of care control

crossover assignment

treatment purpose

The severity of COPD is moderate (GOLD2) or more.
Age: At the time of obtaining consent, an adult patient 40 years or older
Gender: Any
Hospitalization / Outpatient: Outpatient only
Patients who have been given sufficient explanations to participate in this study and have given their full understanding and informed consent from the patient

Patients who cannot breathe nose
Patients with a history of pneumothorax
Patients with active malignancy
Patients with acute disease (such as acute myocardial infarction)
Patients currently diagnosed with asthma (Patients who have a history of asthma but are currently diagnosed with COPD are eligible for inclusion.)
Patients who have been diagnosed with obstructive sleep apnea in the past and who are strongly suspected clinically
Patients already using NHF
Patients who are using non-invasive ventilation (NIV) at night
Patients with severe disease of the kidney, liver or circulatory system
Patients who are considered inappropriate by the Principal Investigator
Patients who are positive for the new coronavirus (SARS-CoV-2) PCR test

Both

COPD

NHF intervention

Rate of expiratory phase after swallowing saliva

1) Time-weighted average value of tcpO2 (average partial pressure during observation period)
2) Time-weighted average value of tcpCO2 (average partial pressure during observation period)
3) Time-weighted average value of SpO2 (average oxygen saturation during observation period)
4) Time-weighted average respiratory rate (average respiratory rate during the observation period)

+81-95-819-7229

April. 28, 2020

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