Protocol summary

Study aim
Evaluation of the effect of lateral position on arterial blood O2 content and O2 saturation in ischemic CVA patients with ventilator-associated pneumonia
Design
Clinical trial without control group, with single group, not blinded, nonrandomized group
Settings and conduct
In this clinical trial study, after coordinating with hospital authorities and ICU ward and providing necessary explanations and consent of patient relatives, 50 ICU patients were selected by convenience sampling method that meet the inclusion criteria mentioned in the study. The method of preparing the patients is that in the supine state, the percentage of hemoglobin saturation is measured by pulse apparatus and ABG (arterial blood gas sample) is prepared from the patient and then changed laterally for two The hour is restored to the percent saturation of hemoglobin and ABG. The samples will be sent to the laboratory under standard conditions and after data analysis and analysis, the results will be presented in thesis and paper.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients 50-70 years old with ischemic CVA; Patients undergoing mechanical ventilation in the ICU; Lack of multiple trauma; No restriction on position change; Exclusion criteria: Instability of vital signs in the new position; Having underlying illness and problem; Oxygen saturation less than 80%
Intervention groups
All patients under study were included in the intervention group.
Main outcome variables
Arterial blood oxygen pressure (FiO2); Oxygen saturation (O2sat)

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20171030037093N29
Registration date: 2020-01-21, 1398/11/01
Registration timing: prospective

Last update: 2020-01-21, 1398/11/01
Update count: 0
Registration date
2020-01-21, 1398/11/01
Registrant information
Name
Sadra Ansaripour
Name of organization / entity
Shahrekord University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3650 3487
Email address
st_ansari.s@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-30, 1398/11/10
Expected recruitment end date
2020-07-31, 1399/05/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of lateral position on arterial blood O2 and saturation percent in patients with ischemic CVA with ventilator associated pneumonia
Public title
The effect of supine position on arterial blood O2 and saturation percentage in patients with ischemic CVA with ventilator-induced pneumonia
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
Patients 50-70 years old with ischemic CVA Patients undergoing mechanical ventilation in the ICU Lack of multiple trauma No restriction on position change
Exclusion criteria:
Instability of vital signs in the new position Having underlying illness and problem Oxygen saturation less than 80%
Age
From 50 years old to 70 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Shahrekord University of Medical Sciences
Street address
Vice chancellor for research, Building No. 2, University headquarters, Ayatollah Kashani Blvd
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713492
Approval date
2018-09-23, 1397/07/01
Ethics committee reference number
IR.SKUMS.REC.1397.152

Health conditions studied

1

Description of health condition studied
Ventilator associated pneumonia
ICD-10 code
J95.851
ICD-10 code description
Ventilator associated pneumonia

Primary outcomes

1

Description
Arterial blood oxygen pressure (FiO2)
Timepoint
For two hours after the supine state
Method of measurement
Pulse Oximeter

2

Description
Oxygen saturation (O2sat)
Timepoint
For two hours after the supine state
Method of measurement
Pulse Oximeter

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: All patients fall into one group and arterial blood pressure and oxygen saturation are assessed in both supine and lateral states.
Category
Diagnosis

Recruitment centers

1

Recruitment center
Name of recruitment center
Ayatollah Kashani Hospital
Full name of responsible person
Farokh Yadollahi
Street address
Ayatollah Kashani Hospital, Nursing Street, Shahrekord
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816758915
Phone
+98 38 3226 4825
Email
Kashani@skums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Shahrekord University of Medical Sciences
Full name of responsible person
Dr. seyed Kamal Solati(Associate Professor of Psychology)
Street address
Vice chancellor for research, Building No. 2, University headquarters, Ayatollah Kashani Blvd
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3334 2414
Email
kamal_solati@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Shahrekord University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Farokh Yadollahi
Position
Assistant Professor of Anesthesiology
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Ayatollah Kashani Hospital, Nursing Street, Shahrekord
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816758915
Phone
+98 38 3226 4825
Email
Farokh.yadollahi1397@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Farokh Yadollahi
Position
Assistant Professor of Anesthesiology
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Ayatollah Kashani Hospital, Nursing Street, Shahrekord
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816758915
Phone
+98 38 3226 4825
Email
Farokh.yadollahi1397@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Farokh Yadollahi
Position
Assistant Professor of Anesthesiology
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Ayatollah Kashani Hospital, Nursing Street, Shahrekord
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816758915
Phone
+98 38 3226 4825
Email
Farokh.yadollahi1397@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Information about the main outcome can be shared.
When the data will become available and for how long
Start the access period 4 months after publishing the results
To whom data/document is available
Researchers working in academia
Under which criteria data/document could be used
Use data to complete clinical trial studies
From where data/document is obtainable
Ayatollah Kashani Hospital
What processes are involved for a request to access data/document
ِAfter the investigation of researcher request and presentation of required documents will be accessible.
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