UMIN-CTR Clinical Trial

Basic information
Public title	Prospective study on accuracy verification of continuous noninvasive finger arterial pressure measurement
Acronym	Prospective study on accuracy verification of continuous noninvasive finger arterial pressure measurement
Scientific Title	Prospective study on accuracy verification of continuous noninvasive finger arterial pressure measurement
Scientific Title:Acronym	Prospective study on accuracy verification of continuous noninvasive finger arterial pressure measurement
Region	Japan

Condition
Condition	Esophageal cancer
Classification by specialty	Gastrointestinal surgery Anesthesiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Accuracy of cardiac output measurement by continuous non invasive arterial pressure measurement (CNAP)
Basic objectives2	Others
Basic objectives -Others	Measurement accuracy
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Cardiac output measured by CNAP is equivalent to cardiac output measured by FloTrac(R)
Key secondary outcomes	Cardiac output measured by CNAP in supine and semipro position are equivalent to cardiac output measured by FloTrac(R)

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Device,equipment
Interventions/Control_1	Continuous noninvasive finger arterial pressure measurement (CNAP) is worn on two adjacent fingers from the time of general anesthesia to the end of the operation.
Interventions/Control_2
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	Not applicable
Gender	Male and Female
Key inclusion criteria	Esophageal cancer (patient undergoing esophagectomy)
Key exclusion criteria	Below 20 years, weighing less than 40 kg or 180 kg or more, BMI 35 or more, neuromuscular disease, frequent arrhythmia (atrial fibrillation, overhaul contraction of more than 10% in Holter's electrocardiogram), hypothermia below 35 degrees, upper extremity Patients who have problems with the artery (shunt, past history used as graft, vascular occlusion, Raynaud's symptom, collagen disease related to limb vessel disease), past history of artificial insertion (measuring artificial femoral head, internal fixation) on the measurement side, In the case of complete lateral decubitus operation using ventilation, when the invasive arterial pressure can not be measured
Target sample size	50

Research contact person
Last name of lead principal investigator	1st name Masanori Middle name Last name Yamauchi
Organization	Tohoku university graduate school of medicine
Division name	Department of anesthesia and perioperative medicine
Zip code	9808572
Address	2-1, Seiryo-machi, Aoba, Sendai, Miyagi
TEL	022-717-7321
Email	yamauchi@med.tohoku.ac.jp

Public contact
1st name of contact person	1st name Naoya Middle name Last name Kobayashi
Organization	Tohoku university graduate school of medicine
Division name	Department of anesthesia and perioperative medicine
Zip code	9808572
Address	2-1, Seiryo-machi, Aoba, Sendai, Miyagi
TEL	022-717-7321
Homepage URL
Email	naoya.kobayashi.q4@dc.tohoku.ac.jp

Sponsor
Institute	Tohoku university graduate school of medicine, Department of anesthesia and perioperative medicine
Institute
Department

Funding Source
Organization	Self funding
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	MHLW Certified Clinical Research Review Board, Tohoku University
Address	2-1-1 Katahira, Aoba-ku, Sendai, Miyagi, 980-8577 Japan
Tel	0227180461
Email	office@nrs.hosp.tohoku.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	東北大学病院（宮城県）

Other administrative information
Date of disclosure of the study information	2018 Year 06 Month 01 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	Suspended
Date of protocol fixation	2018 Year 05 Month 01 Day
Date of IRB	2018 Year 09 Month 21 Day
Anticipated trial start date	2018 Year 06 Month 01 Day
Last follow-up date	2020 Year 03 Month 31 Day
Date of closure to data entry	2020 Year 03 Month 31 Day
Date trial data considered complete
Date analysis concluded	2020 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2018 Year 05 Month 01 Day
Last modified on	2019 Year 05 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000036993