The comparison of two methods of ventilation (Bag mask ventilation vs Semi-open ventilation) on O2 saturation of patients undergoing Electro Convulsive Therapy (ECT)
The aim of this single-blind randomized trial is to assess the effect of semi-open ventilation system on arterial oxygen saturation. In this study, 72 eligible patients who are scheduled for electroconvulsive therapy under general anesthesia are conducted to the study. The patients are divided into two groups (Control and Test) using random allocation. During anesthesia, the patients in the Test group are ventilated by semi-open system and the patients in the Control group are ventilated by Ambu-bag system. Arterial oxygen saturation (SpO2) is recorded before and after preoxygenation as well as before convulsion as basic data. Arterial oxygen saturation is recorded one-minute interval after convulsion until recovery of spontaneous ventilation is adequate. Statistical analysis is done after collecting date.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201504162832N2
Registration date:2015-05-16, 1394/02/26
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-05-16, 1394/02/26
Registrant information
Name
Mahmood Akhlaghi
Name of organization / entity
Shahrekord University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 38 3333 4691
Email address
akhlaghi@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of Research, Shahrekord university of Medical Sciences
Expected recruitment start date
2011-03-20, 1389/12/29
Expected recruitment end date
2012-03-19, 1390/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of two methods of ventilation (Bag mask ventilation vs Semi-open ventilation) on O2 saturation of patients undergoing Electro Convulsive Therapy (ECT)
Public title
The comparison of two methods of ventilation during Electro Convulsive Therapy (ECT)
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: candidates for ECT; age of 18-50 years; ASA 1 or 2
Exclusion criteria: patients with cardiovascular or respiratory diseases; ASA 3 or 4; patients with internal medicine diseases; lack of consent
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahrekord University of Medical Sciences
Street address
Shahrekord University of Medical Sciences, Kashani Street
City
Shahrekord
Postal code
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
90-3-4
Health conditions studied
1
Description of health condition studied
General Anesthesia during Electro Convulsive Therapy
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Arterial Oxygen Saturation
Timepoint
Before ECT and 10 minutes therafter
Method of measurement
Percent of arterial oxygen saturation using pulse oximetry
Secondary outcomes
empty
Intervention groups
1
Description
Using ventilation with Semi-open system in the Test group.
Category
Prevention
2
Description
Using ventilation with Ambu-bag system in the Control group.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Psychiatry ward, Hajar hospital
Full name of responsible person
Mahmood Akhlaghi
Street address
Anesthesiology Department, Shahrekord University of Medical Sciences
City
Shahrekord
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
Dr. Mahmood Mobasheri
Street address
Deputy of Research, Shahrekord University of Medical Sciences, Kashani Street
City
Shahrekord
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahrekord University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
Mahmood Akhlaghi
Position
Associate Professor of Anesthesiology Department, Academic Staff
Other areas of specialty/work
Street address
Anesthesiology Department, Shahrekord University of Medical Sciences
City
Shahrekord
Postal code
8815713471
Phone
+98 38 3333 4691
Fax
Email
akhlaghi236@yahoo.com, akhlaghi@skums.ac.ir
Web page address
www.skums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
Mahmood Akhlaghi
Position
Anesthesiologist
Other areas of specialty/work
Street address
Anesthesiology Department, Shahrekord University of Medical Sciences
City
Shahrekord
Postal code
8815713471
Phone
+98 38 3333 4691
Fax
Email
akhlaghi236@yahoo.com, akhlaghi@skums.ac.ir
Web page address
www.skums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
Mahmood Akhlaghi
Position
Associate Professor of Anesthesiology Department
Other areas of specialty/work
Street address
Anesthesiology Department, Shahrekord University of Medical Sciences
City
Shahrekord
Postal code
8815713471
Phone
+98 38 3333 4691
Fax
Email
akhlaghi236@yahoo.com, akhlaghi@skums.ac.ir
Web page address
www.skums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)