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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023617
Receipt No. 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

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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
Email 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
Email ds0226@fsinet.or.jp

Sponsor
Institute Juntendo University School of Medicine
Institute
Department

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
Email 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
URL(English) https://upload.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


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