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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000048103
Receipt No. R000054260
Scientific Title Effects of combined therapy of upper body elebation and highflow nasal cannula on postoperative high-sensitivity troponin T in severe obstructive sleep apnea patients undergoing major surgery: a randomized control study
Date of disclosure of the study information 2022/06/20
Last modified on 2022/06/20

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Basic information
Public title Effects of combined therapy of upper body elebation and highflow nasal cannula on postoperative high-sensitivity troponin T in severe obstructive sleep apnea patients undergoing major surgery: a randomized control study
Acronym high flow nasal cannula and postoperative troponin T
Scientific Title Effects of combined therapy of upper body elebation and highflow nasal cannula on postoperative high-sensitivity troponin T in severe obstructive sleep apnea patients undergoing major surgery: a randomized control study
Scientific Title:Acronym high flow nasal cannula and postoperative troponin T
Region
Japan

Condition
Condition myocardial injury after noncardiac surgery
Classification by specialty
Cardiology Surgery in general Anesthesiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To test a hypothesis that the combined therapy of upper body elevation and high flow nasal cannula for postoperative respiratory management suppresses postoperative increase of high-sensitivity troponin T in patients with severe obstructive sleep apnea undergoing major thoracic or abdominal surgery
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes maximum difference of high-sensitivity troponin T before and after surgery
Key secondary outcomes incidence of Myocardial Injury after Non-cardiac Surgery, incidence of high-sensitivity troponin T greater than 0.005 ng/mL, major postoperative complications within 30 days after surgery,

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment Maneuver
Interventions/Control_1 a combination of upper body elebation and high flow nasal cannula
Interventions/Control_2 a combination of supine and oxygen therapy
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
45 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients undergoing major thoracic or abdominal surgery under general anesthesia combined with thoracic epidural anesthesia who have at least more than 3 risk factors for Myocardial Injury after Non-cardiac Surgery such as older than 75 years, male, atrial fibrillation, diabetes, hypertension, cardiac failure (history), coronary artery disease, peripheral vascular disease, renal dysfunction (eGFR<60), and stroke.
Key exclusion criteria 1. emergency surgery
2. palliative operation
3. severe renal dysfunction (eGFR<15 or dialysis patients)
4. severe respiratory disease with hypoxemia and/or hypercapnia
5. oxygen therapy before surgery
6. unable to accept high-flow nasal cannula therapy
7. renal and ureteral surgery
8. sepsis
9. use of antimicrobials before surgery
10. pulmonary embolism
11. preoperative high-sensitivity troponin T levels greater than or equal to0.065 ng/mL
12. difficulty of obtaining concents from the patient
13. judged by the principal investigator to be inappropriate as a participant
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Yoshihiro
Middle name
Last name Yamaji
Organization Graduate School of Medicine, Chiba University
Division name Department of Anesthesiology
Zip code 260-8670
Address 1-8-1 Inohana, Chuo-ku, Chiba city, Chiba, Japan
TEL 043-222-7171
Email yamayoshi1228@yahoo.co.jp

Public contact
Name of contact person
1st name Yoshihiro
Middle name
Last name Yamaji
Organization Graduate School of Medicine, Chiba University
Division name Department of Anesthesiology
Zip code 260-8670
Address 1-8-1 Inohana, Chuo-ku, Chiba city, Chiba, Japan
TEL 043-222-7171
Homepage URL
Email yamayoshi1228@yahoo.co.jp

Sponsor
Institute Chiba University

Institute
Department

Funding Source
Organization Others
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 Graduate School of Medicine, Chiba University
Address 1-8-1 Inohana, Chuo-ku, Chiba city, Chiba, Japan
Tel 043-222-7171
Email igaku-rinri@office.chiba-u.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 千葉大学医学部附属病院(千葉県)
Chiba University Hospital

Other administrative information
Date of disclosure of the study information
2022 Year 06 Month 20 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Preinitiation
Date of protocol fixation
2022 Year 05 Month 26 Day
Date of IRB
2022 Year 05 Month 26 Day
Anticipated trial start date
2022 Year 07 Month 01 Day
Last follow-up date
2024 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2022 Year 06 Month 20 Day
Last modified on
2022 Year 06 Month 20 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054260

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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