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Name:
UMIN ID:

Recruitment status Suspended
Unique ID issued by UMIN UMIN000032439
Receipt No. R000036993
Scientific Title Prospective study on accuracy verification of continuous noninvasive finger arterial pressure measurement
Date of disclosure of the study information 2018/06/01
Last modified on 2019/05/09

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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
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
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/ctr_e/ctr_view.cgi?recptno=R000036993

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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