UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023617 |
|---|---|
| Receipt number | R000027196 |
| Scientific Title | high-flow nasal oxygen therapy after esophagectomy for thoracic esophageal cancer |
| Date of disclosure of the study information | 2016/08/14 |
| Last modified on | 2021/08/18 08:21:08 |
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Basic information
Public title
high-flow nasal oxygen
therapy after esophagectomy for thoracic esophageal cancer
Acronym
high-flow nasal oxygen
therapy after esophagectomy
Scientific Title
high-flow nasal oxygen
therapy after esophagectomy for thoracic esophageal cancer
Scientific Title:Acronym
high-flow nasal oxygen
therapy after esophagectomy
Region
| Japan |
Condition
Condition
after esophagectomy for thoracic esophageal cancer
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
the routine administration
of nasal high-flow oxygen therapy (NHF)
improves pulmonary function after
esophagectomy for thoracic esophageal
cancer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
atelectasis score on chest X-ray, intensive care and hospital length of
stay, mortality on Day 28; escalation of respiratory support and patient comfort.
Key secondary outcomes
PaO2/FIO2, intensive care and hospital
length of stay, mortality on Day 28;
escalation of respiratory support and
patient comfort.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
high-flow nasal oxygen therapy/ Venturi mask
Interventions/Control_2
1 week
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
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
the patients who underwent esophagectomy
for thoracic esophageal cancer
Key exclusion criteria
not intubated patient
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Daizoh |
| Middle name | |
| Last name | Satoh |
Organization
Juntendo University School of Medicine
Division name
Department of Anesthesiology and Pain Medicine
Zip code
113-8421
Address
2-1-1,Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-3813-3111
ds0226@fsinet.or.jp
Public contact
Name of contact person
| 1st name | Daizoh |
| Middle name | |
| Last name | Satoh |
Organization
Juntendo University School of Medicine
Division name
Department of Anesthesiology and Pain Medicine
Zip code
113-3111
Address
2-1-1,Hongo, Bunkyo-ku, Tokyo, Japan
TEL
080-3813-3111
Homepage URL
ds0226@fsinet.or.jp
Sponsor or person
Institute
Juntendo University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Juntendo University School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics comitte at Juntendo University Hospital
Address
2-1-1, Hongo, Bunkyo-ku, Tokyo
Tel
03-3813-3111
kenkyu5858@juntendo.ac.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
順天堂医院
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 08 | Month | 14 | Day |
Related information
URL releasing protocol
DOI:10.29011/2575-9760.001369
Publication of results
Published
Result
URL related to results and publications
DOI:10.29011/2575-9760.001369
Number of participants that the trial has enrolled
63
Results
The nasal high-flow therapy group prevented the deterioration of oxygenation compared with the Venturi mask therapy group at POD2. The total fluid balance continued plus balance until POD2 in both groups.
Results date posted
| 2021 | Year | 08 | Month | 18 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
After open esophagectomy for esophageal cancer,
Participant flow
We conducted a randomized trial to determine the relationship between oxygenation and in-out fluid balance by nasal high-flow therapy (NHFT) after open esophagectomy for esophageal cancer, compared with Venturi mask (VM) therapy
Adverse events
None
Outcome measures
oxygenation and in-out fluid balance by nasal high-flow therapy (NHFT) after open esophagectomy for esophageal cancer, compared with Venturi mask (VM) therapy
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 08 | Month | 14 | Day |
Date of IRB
| 2016 | Year | 12 | Month | 16 | Day |
Anticipated trial start date
| 2016 | Year | 08 | Month | 14 | Day |
Last follow-up date
| 2019 | Year | 08 | Month | 14 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 08 | Month | 14 | Day |
Last modified on
| 2021 | Year | 08 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027196
| Research Plan | |
|---|---|
| Registered date | File name |
| 2021/03/05 | NHFT j Surg.pdf |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2021/03/05 | NHFT j Surg.pdf |
| Research case data | |
|---|---|
| Registered date | File name |
| 2021/03/05 | NHFT j Surg.pdf |
