Unique ID issued by UMIN | UMIN000019238 |
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Receipt number | R000022236 |
Scientific Title | The comparison nasal high-flow oxygen therapy with large volume nebulization-based humidifier for patients after the extubation: randomized controlled study |
Date of disclosure of the study information | 2015/10/05 |
Last modified on | 2019/07/15 14:28:02 |
The comparison nasal high-flow oxygen therapy with large volume nebulization-based humidifier for patients after the extubation: randomized controlled study
Prospective randomized controlled study of Nasal High-flow Oxygen Therapy
The comparison nasal high-flow oxygen therapy with large volume nebulization-based humidifier for patients after the extubation: randomized controlled study
Prospective randomized controlled study of Nasal High-flow Oxygen Therapy
Japan |
Respitratory failure after extubation
Emergency medicine | Intensive care medicine |
Others
NO
Efficacy of nasal high-flow oxygen therapy
Safety,Efficacy
Re-intubation rate within a week
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
2
Treatment
Device,equipment |
nasal high-flow oxygen therapy
large volume nebulization-based humidifier
18 | years-old | <= |
Not applicable |
Male and Female
1. Obtained a written informed consent
2. Patients received a mechanical ventilation for more than 24 hours
3. Patients who are admitted to the emergency department or ICU, and underwent a management of the mechanical ventilation and oxygen therapy by the stuff of the emergency department.
4. Patients who received extubation within 14 days after obtained the written informed consent
5. Patients with PaO2/FIO2 < 300 within 3 hours before extubation.
1.Patients with severe facial injury
2.Pregnancy
3.Patients with tracheostomy
4.Patients who had pneumothorax without thoracic drainage
5.Patients advocate 'Do-not-intubate status' before included this study.
180
1st name | Akiyoshi |
Middle name | |
Last name | Hagiwara |
National Center for Global Health and Medicine
Emergency department
162-8655
Toyama 1-21-1, shinjuku-ku, Tokyo
03-3202-7181
wmatsuda@hosp.ncgm.go.jp
1st name | Wataru |
Middle name | |
Last name | Matsuda |
National Center for Global Health and Medicine
Emergency department
162-0055
Toyama 1-21-1, shinjuku-ku, Tokyo
03-3202-7181
wmatsuda@hosp.ncgm.go.jp
National Center for Global Health and Medicine
None
Self funding
National Center for Global Health and Medicine
1-21-1, Toyama, Shinjuku-ku, Tokyo
09076476900
wmatsuda@hosp.ncgm.go.jp
NO
2015 | Year | 10 | Month | 05 | Day |
none
Unpublished
none
72
A total of 72 patients were enrolled in this study between August 2015 and March 2018. We analyzed 69 subjects, 30 in the intervention group and 39 in the control group. Baseline characteristics were similar between the two groups.
The reintubation rate within 7 days did not differ significantly between the two groups (intervention group 5/30 subjects [17%] vs control group 6/39 subjects [15%]).
2019 | Year | 07 | Month | 15 | Day |
Baseline characteristics were similar between the two groups. Mean age was 76 years and the main cause of respiratory failure was pneumonia (56%).
A total of 72 patients were enrolled in this study between August 2015 and March 2018. We analyzed 69 subjects, 30 in the intervention group and 39 in the control group.
One severe adverse event was detected in the intervention group, where cardiac arrest due to airway obstruction by mucous plug occurred after protocol treatment.
The reintubation rate within 7 days after extubation (primary endpoint): intervention group 5/30 (17%), control group 6/39 (15%), odds ratio 1.10 (0.24-4.88)
The reintubation rate within 48 hours after extubation: intervention group 2/30 (7%), control group 5/39 (13%), odds ratio 0.49 (0.04-3.28)
The rate of reintubation or non-invasive ventilation use within 48 hours after extubation:intervention group 2/30 (7%), control group 8/39 (21%), odds ratio 0.28 (0.03-1.58)
PaO2 / FIO2set ratio within 24 hours after extubation: intervention group mean 264 mmHg, control group mean 224 mmHg
Reason for reintubation: sputum obstruction was most (intervention group 2/30 (7%), control group 3/39 (8%))
Length of oxygen therapy: intervention group mean 5.6 days, control group maen 5.9 days
Length of ICU stay: intervention group mean 4.4 days, control group mean 3.8 days
discomfort of each devices: no significant difference in either group at 1, 6, 24 or 48 hours after extubation
Completed
2015 | Year | 07 | Month | 28 | Day |
2015 | Year | 07 | Month | 21 | Day |
2015 | Year | 08 | Month | 01 | Day |
2018 | Year | 03 | Month | 31 | Day |
2018 | Year | 03 | Month | 31 | Day |
2019 | Year | 03 | Month | 01 | Day |
2019 | Year | 04 | Month | 08 | Day |
2015 | Year | 10 | Month | 05 | Day |
2019 | Year | 07 | Month | 15 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022236
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