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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000019238
Receipt No. 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

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Basic information
Public title The comparison nasal high-flow oxygen therapy with large volume nebulization-based humidifier for patients after the extubation: randomized controlled study
Acronym Prospective randomized controlled study of Nasal High-flow Oxygen Therapy
Scientific Title The comparison nasal high-flow oxygen therapy with large volume nebulization-based humidifier for patients after the extubation: randomized controlled study
Scientific Title:Acronym Prospective randomized controlled study of Nasal High-flow Oxygen Therapy
Region
Japan

Condition
Condition Respitratory failure after extubation
Classification by specialty
Emergency medicine Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Efficacy of nasal high-flow oxygen therapy
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Re-intubation rate within a week
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 nasal high-flow oxygen therapy
Interventions/Control_2 large volume nebulization-based humidifier
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 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.
Key exclusion criteria 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.
Target sample size 180

Research contact person
Name of lead principal investigator
1st name Akiyoshi
Middle name
Last name Hagiwara
Organization National Center for Global Health and Medicine
Division name Emergency department
Zip code 162-8655
Address Toyama 1-21-1, shinjuku-ku, Tokyo
TEL 03-3202-7181
Email wmatsuda@hosp.ncgm.go.jp

Public contact
Name of contact person
1st name Wataru
Middle name
Last name Matsuda
Organization National Center for Global Health and Medicine
Division name Emergency department
Zip code 162-0055
Address Toyama 1-21-1, shinjuku-ku, Tokyo
TEL 03-3202-7181
Homepage URL
Email wmatsuda@hosp.ncgm.go.jp

Sponsor
Institute National Center for Global Health and Medicine
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization National Center for Global Health and Medicine
Address 1-21-1, Toyama, Shinjuku-ku, Tokyo
Tel 09076476900
Email wmatsuda@hosp.ncgm.go.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2015 Year 10 Month 05 Day

Related information
URL releasing protocol none
Publication of results Unpublished

Result
URL related to results and publications none
Number of participants that the trial has enrolled 72
Results
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%]).
Results date posted
2019 Year 07 Month 15 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Baseline characteristics were similar between the two groups. Mean age was 76 years and the main cause of respiratory failure was pneumonia (56%).
Participant flow
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.
Adverse events
One severe adverse event was detected in the intervention group, where cardiac arrest due to airway obstruction by mucous plug occurred after protocol treatment. 
Outcome measures
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
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2015 Year 07 Month 28 Day
Date of IRB
2015 Year 07 Month 21 Day
Anticipated trial start date
2015 Year 08 Month 01 Day
Last follow-up date
2018 Year 03 Month 31 Day
Date of closure to data entry
2018 Year 03 Month 31 Day
Date trial data considered complete
2019 Year 03 Month 01 Day
Date analysis concluded
2019 Year 04 Month 08 Day

Other
Other related information

Management information
Registered date
2015 Year 10 Month 05 Day
Last modified on
2019 Year 07 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022236

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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