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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000046544
Receipt No. R000053089
Scientific Title To evaluate seizure quality in mECT between one-handed and two-handed facemask techniques
Date of disclosure of the study information 2022/01/05
Last modified on 2022/01/05

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Basic information
Public title To evaluate seizure quality in mECT between one-handed and two-handed facemask techniques
Acronym To evaluate seizure quality in mECT between one-handed and two-handed facemask techniques
Scientific Title To evaluate seizure quality in mECT between one-handed and two-handed facemask techniques
Scientific Title:Acronym To evaluate seizure quality in mECT between one-handed and two-handed facemask techniques
Region
Japan

Condition
Condition patients aged > 18 years who were referred to receive ECT by their treating psychiatrist
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate how to effectively use a facemask to accomplish protocolized hyperventilation which is a useful adjunct to augment seizure duration and improve seizure quality: retrospective study
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Motor seizure duration, EEG seizure duration, Stimulation dose, Ictal EEG characteristics (Regularity, Postictal suppression, Activation of the sympathetic nervous system), End-tidal carbon dioxide
Key secondary outcomes Dose of thiopental, Ventilatory volume during one breath, Difference between inhaled and exhaled ventilatory volumes, Ventilation rate, Minute ventilation, Difference between inhaled and exhaled minute ventilations

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who were referred to receive ECT by their treating psychiatrist, those receiving thiopental alone as an anesthetic
Key exclusion criteria Patients who received general anesthesia with propofol, ketamine and remifentanil. Those with past or current major neurological illness or injury
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Yoko
Middle name
Last name Shimamoto
Organization National Hospital Organization Kure Medical Center and Chugoku Cancer Center
Division name Department of Anesthesiology
Zip code 737-0023
Address 3-1 Aoyama, Kure, Hiroshima, Japan
TEL 0823-22-3111
Email j036eb@yahoo.co.jp

Public contact
Name of contact person
1st name Michiyoshi
Middle name
Last name Sanuki
Organization National Hospital Organization Kure Medical Center and Chugoku Cancer Center
Division name Department of Anesthesiology
Zip code 737-0023
Address 3-1 Aoyama, Kure, Hiroshima, Japan
TEL 0823-22-3111
Homepage URL
Email msanuki@ff.iij4u.or.jp

Sponsor
Institute National Hospital Organization Kure Medical Center and Chugoku Cancer Center
Institute
Department

Funding Source
Organization National Hospital Organization Kure Medical Center and Chugoku Cancer Center
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Institutional review board at Kure Medical Center
Address 3-1,Aoyama,Kure,Hiroshima,Japan
Tel 0823223111
Email yokoo.reina.gs@mail.hosp.go.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

Other administrative information
Date of disclosure of the study information
2022 Year 01 Month 05 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 60
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
2021 Year 06 Month 03 Day
Date of IRB
2021 Year 06 Month 03 Day
Anticipated trial start date
2021 Year 06 Month 03 Day
Last follow-up date
2022 Year 01 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Retrospective Analysis

Management information
Registered date
2022 Year 01 Month 05 Day
Last modified on
2022 Year 01 Month 05 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053089

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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