Unique ID issued by UMIN | UMIN000035738 |
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Receipt number | R000040695 |
Scientific Title | A phase II study of HFNC in advanced cancer patients with dyspnea and poor PS |
Date of disclosure of the study information | 2019/02/01 |
Last modified on | 2019/02/01 13:02:02 |
A phase II study of HFNC in advanced cancer patients with dyspnea and poor PS
A phase II study of HFNC in advanced cancer patients with dyspnea and poor PS
A phase II study of HFNC in advanced cancer patients with dyspnea and poor PS
A phase II study of HFNC in advanced cancer patients with dyspnea and poor PS
Japan |
advanced cancer
Pneumology |
Malignancy
NO
To evaluate the efficacy and safety of HFNC in advanced cancer patients who have dyspnea and poor PS.
Safety,Efficacy
Phase II
Change amount of modified Borg scale at the start of treatment 24hours
1. Change amount of modified Borg scale
2. Change amount of comfort(Numerical Rating Scale)
3. Respiratory rate
4. Implementention rate of medical therapy
5. SpO2
6. Glassgow Coma Scale
7. Completion rate of treatment
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Device,equipment |
High flow nasal cannula oxygen therapy
20 | years-old | <= |
Not applicable |
Male and Female
1. Patients who are diagnosed with advanced cancer.
2. ECOG PS 3/4
3. Patients who have dyspnea of 3 or more in NRS.
4. Patients with PaO2 <= 60 Torr or SpO2 <= 90%.
5. Patients who are more than 20 years old at the time of the informed consent.
6. Patients who agree to participate in the study with the written informed consent.
1. Patients who need 8 or more opioid rescue use per day.
2. Patients who plan artificial respiration management.
3. Patients who already have used HFNC.
4. Patients who have disturbance of consciousness of 12 or less GCS.
5. Patients under sustained sedation.
6. Patients with cognitive impairment or mental disorder who are regarded as inadequate to evaluate for the study by the investigators.
7. Patients who have participated in the other study at the time of the informed consent, or will participate in the other study.
8. Any other cases who are regarded as inadequate for the study enrollment by the investigators.
24
1st name | |
Middle name | |
Last name | Nobuyuki Yamamoto |
Wakayama Medical University
Third Department of Internal Medicine
Kimiidera 811-1, Wakayama-city, Wakayama, Japan
073-441-0619
nbyamamo@wakayama-med.ac.jp
1st name | |
Middle name | |
Last name | Shunsuke Teraoka |
Wakayama Medical University
Third Department of Internal Medicine
Kimiidera 811-1, Wakayama-city, Wakayama, Japan
073-441-0619
teraoka@wakayama-med.ac.jp
Wakayama Medical University
Wakayama Medical University
Other
NO
2019 | Year | 02 | Month | 01 | Day |
Unpublished
Preinitiation
2019 | Year | 02 | Month | 01 | Day |
2019 | Year | 02 | Month | 11 | Day |
2019 | Year | 02 | Month | 01 | Day |
2019 | Year | 02 | Month | 01 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040695
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