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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024317
Receipt No. R000028009
Scientific Title The effects of phenylephrine on oxygenation during one-lung ventilation; a randomized, double-blind, cross-over study
Date of disclosure of the study information 2016/10/06
Last modified on 2017/11/20

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Basic information
Public title The effects of phenylephrine on oxygenation during one-lung ventilation; a randomized, double-blind, cross-over study
Acronym The effects of phenylephrine on oxygenation during one-lung ventilation
Scientific Title The effects of phenylephrine on oxygenation during one-lung ventilation; a randomized, double-blind, cross-over study
Scientific Title:Acronym The effects of phenylephrine on oxygenation during one-lung ventilation
Region
Japan

Condition
Condition Adult patients undergoing elective thoracic surgery in the lateral decubitus position with at least 70 minutes of one-lung ventilation
Classification by specialty
Anesthesiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effects of phenylephrine infusion on oxygenation during one-lung ventilation in patients undergoing thoracic surgery
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Arterial oxygen pressure after intervention
Key secondary outcomes Mean Arterial Pressure, HeartRate, Pulse Pressure Variation, Perfusion Index, and Difference between Bladder Temperature and Skin Temperature

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Intravenous phenylephrine infusion (20 mL/h = 15 mcg/min) for 30 minutes
Interventions/Control_2 Normal Saline infusion at a speed of 20 mL/h for 30 minutes
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
75 years-old >=
Gender Male and Female
Key inclusion criteria Adult patients with ASA physical status 1-3 undergoing elective thoracic surgery in the lateral decubitus position with at least 70 minutes of one-lung ventilation
Key exclusion criteria History of stroke, uncompensated cardiac disease, or arrhythmias
Target sample size 35

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kohei Godai
Organization Kagoshima University Hospital
Division name Department of Anesthesiology
Zip code
Address 8-35-1 Sakuragaoka, Kagoshima 890-8520, Japan
TEL +81-99-275-5430
Email kouhei84@m2.kufm.kagoshima-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kohei Godai
Organization Kagoshima University Hospital
Division name Department of Anesthesiology
Zip code
Address 8-35-1 Sakuragaoka, Kagoshima 890-8520, Japan
TEL +81-99-275-5430
Homepage URL
Email kouhei84@m2.kufm.kagoshima-u.ac.jp

Sponsor
Institute Graduate School of Medical and Dental Sciences, Kagoshima University
Institute
Department

Funding Source
Organization Graduate School of Medical and Dental Sciences, Kagoshima University
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
Address
Tel
Email

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

Other administrative information
Date of disclosure of the study information
2016 Year 10 Month 06 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 Completed
Date of protocol fixation
2016 Year 10 Month 06 Day
Date of IRB
Anticipated trial start date
2016 Year 10 Month 06 Day
Last follow-up date
2017 Year 11 Month 14 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 10 Month 06 Day
Last modified on
2017 Year 11 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028009

Research Plan
Registered date File name
2018/01/30 20160217 HPV臨床研究倫理委員会 申請書.pdf

Research case data specifications
Registered date File name

Research case data
Registered date File name
2018/03/14 20180225 HPV phenylephrine data.xlsx


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