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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000023708
Receipt No. R000027301
Scientific Title Open lavel single center crossover study concerning the change of PVI(Pleth Variability Index) and SVV(Stroke Volume Valiance) durung mECT(modified Electro Convulsive Therapy).
Date of disclosure of the study information 2016/08/21
Last modified on 2018/09/08

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Basic information
Public title Open lavel single center crossover study concerning the change of PVI(Pleth Variability Index) and SVV(Stroke Volume Valiance) durung mECT(modified Electro Convulsive Therapy).
Acronym Prospective study concerning the change of PVI and SVV durung mECT.
Scientific Title Open lavel single center crossover study concerning the change of PVI(Pleth Variability Index) and SVV(Stroke Volume Valiance) durung mECT(modified Electro Convulsive Therapy).
Scientific Title:Acronym Prospective study concerning the change of PVI and SVV durung mECT.
Region
Japan

Condition
Condition Scheduled mECT cases of ASA 1 or 2.
Classification by specialty
Psychiatry Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Our goal in this study is to provide safer perioperative care for scheduled mECT through verification of the change of pleth variability index (PVI) and stroke volume valiance.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Others
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes The difference of the change of PVI and SVV during mECT
Key secondary outcomes 1. The difference of the change of PVI during mECT (comparison between first time and second time)
2. The difference of the change of SVV during mECT(comparison between first time and second time)

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 Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Patients are prohibited eating from 9 p.m.of the previous night of mECT. After entering operating room, patient is monitered ECG, NIBP, SpO2, temperature and PVI of Masimo Radical 7 and SVV of ClearSight Fiinger Cuff (Edwards). Each of data is recorded throughout operation. After control EEG measurement, propofol 1mg/kg is administered. If the patient is alert after 3 minutes of administration, additional 0.2mg/kg is administered. This process is repeated until loss of awareness. After that, thigh mounted cuff is pressurred to 250mmHg, 1mg/kg of succinylcholine is administered.
ECT is done after one minutes's hand ventilation of twenty times per minute to inspiratory pressure 15mmg after confirming the oncet and dissipation of fasciculation. After the end of ECT, hand ventilation of six times per minute to inspiratory pressure 15mmg is continued until emergence of spontaneous respiration. Data of PVI and SVV are acquired until leaving operation room time. A comparison of change of PVI and SVV of following four points are checked after that. 1.After entering operation room and before anesthsia, 2.After administration of propofol and succinylcholine (just before ECT), 3.One minute after the ECT, 4.After awakening. The second time's ECT dose of propofol and succinylcholine is set to the same as the first time's total dose. In the case of ECT is uneffective, the second time's ECT dose of propofol is set to 0.8mg/kg.
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1.ASA 1or 2 of scheduled mECT
2.Weight from 45kg to 90kg
3.Fully apprehended as to purport or meaning of the study and with written consent (approved by the ethics committee) after received an explanation.
Key exclusion criteria 1.Allergic or having contraindication to any medicine used in this study
2.Peripheral vascular disorder
3.Cardiovascular disturbance, Cerebrovascular disorder
4.Neuromuscular disease
5.BMI>35
6.Renal impairment (estimated Ccr<30)
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tomoyuki Sato
Organization saiseikai yokohamashi tobu hospital
Division name department of anesthesiology
Zip code
Address 3-6-1 shimosueyoshi turumi-ku yo kohama-shi kanagawa-ken
TEL 045-576-3000
Email tomoyukisatoh@seagreen.ocn.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tomoyuki Sato
Organization saiseikai yokohamashi tobu hospit al
Division name department of anesthesiology
Zip code
Address 3-6-1 shimosueyoshi turumi-ku yo kohama-shi kanagawa-ken
TEL 045-576-3000
Homepage URL
Email tomoyukisatoh@seagreen.ocn.ne.jp

Sponsor
Institute saiseikai yokohamashi tobu hospital
Institute
Department

Funding Source
Organization saiseikai yokohamashi tobu hospit
al
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 08 Month 21 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
2016 Year 08 Month 20 Day
Date of IRB
Anticipated trial start date
2016 Year 08 Month 21 Day
Last follow-up date
2019 Year 08 Month 31 Day
Date of closure to data entry
2019 Year 09 Month 15 Day
Date trial data considered complete
2019 Year 09 Month 30 Day
Date analysis concluded
2019 Year 10 Month 31 Day

Other
Other related information

Management information
Registered date
2016 Year 08 Month 21 Day
Last modified on
2018 Year 09 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027301

Research Plan
Registered date File name
2017/10/05 mECT倫理提出11.20..docx

Research case data specifications
Registered date File name
2017/10/05 登録票mECT.xlsx

Research case data
Registered date File name
2017/10/05 症例報告書 m-ECT11.4..xlsx


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