UMIN-CTR Clinical Trial

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

Contact us.