UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048103 |
|---|---|
| Receipt number | 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 | 2025/01/04 13:51:22 |
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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
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
yamayoshi1228@yahoo.co.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
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
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
Open public recruiting
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 | 08 | Month | 01 | Day |
Last follow-up date
| 2025 | 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
| 2025 | Year | 01 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054260
