Determine the effect of the active respiratory cycle technique on arterial blood gases
Design
A clinical trial with a control group, with a parallel, double-blind, randomized, clinical trial
Settings and conduct
After obtaining permission from the ethics committee in the research of Rafsanjan University of Medical Sciences and presenting a referral to the deputy of the Kerman University of Medical Sciences and obtaining informed consent from the patients, one of the researchers will sample. The initial arrival of the samples is based on the target and then in a randomized manner, minimization, will be placed in two groups of intervention and control, so that both groups will be matched in terms of gender and cause of open heart surgery. The first sample will be entered in classes in a simple random order and then based on the total number of samples in each class.
Participants/Inclusion and exclusion criteria
Patient entry criteria include:
Age aged 18-60 years; Sternotomy with or without valve replacement
Intervention groups
There are two intervention and control groups in this study. In the intervention group, the active respiratory cycle technique is implemented in two days and the routine physiotherapy control group is performed.
Main outcome variables
The average amount of arterial blood gas before and after intervention in two consecutive days
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180304038935N1
Registration date:2018-06-27, 1397/04/06
Registration timing:registered_while_recruiting
Last update:2018-06-27, 1397/04/06
Update count:0
Registration date
2018-06-27, 1397/04/06
Registrant information
Name
Ahmad Salehi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3315 0007
Email address
ahmadsalehi2117@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-21, 1397/02/01
Expected recruitment end date
2018-10-23, 1397/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study the effect of Active Cyclic breathing technique on arterial blood gas measures in patient undergoing open heart surgery
Public title
Study the effect of Active Cyclic breathing technique on arterial blood gas measures
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age aged 18-60 years
Performing a wind sternotomy or without switching the valve
The patient is able to speak and understand Persian language
Inclination to participate in research
Exclusion criteria:
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
This study was a randomized clinical trial with control group. The initial arrival of the samples is based on the target and then in a randomized manner(minimization) will be placed in two groups of intervention and control, so that both groups will be matched in terms of gender and cause of open heart surgery. The first sample will be entered in classes in a simple random order and then based on the total number of samples in each class.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the participants are evaluated and blinded to the outcome, so that after a complete explanation of the method of implementation and the stages of the study and obtaining the written consent of patients, they are divided into two groups of intervention and control in the routine physiotherapy control group And the respiratory cycle is performed in the intervention group, but the patient does not know which physiotherapy has been received.
In this study, the individual who evaluated the response to arterial blood gas tests does not have any information on the participants in the intervention and control group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Rafsanjan University of Medical Sciences
Street address
Central Organization, Imam Blvd , Rafsanjan
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Approval date
2018-04-18, 1397/01/29
Ethics committee reference number
IR.RUMS.REC.1397.010
Health conditions studied
1
Description of health condition studied
Respiratory problems in patients undergoing open heart surgery
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Arterial blood gas levels
Timepoint
During the two days after the extubation of the trachea before and after the respiratory physiotherapy, the amount of arterial blood gas is measured.
Method of measurement
The GEM Premier 3000 device is used to measure arterial blood gases
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: For the intervention group, the active respiratory cycle technique is performed one day each day during the two days after the extubation of the trachea.
Category
Other
2
Description
Control group: A routine respiratory physiotherapy that will stimulate coughing and use a breathable vibrator in two days after the end of the tracheal tube.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shafa Hospital in Kerman
Full name of responsible person
Dr.Tayebe Negahban
Street address
Shafa Hospital, Kowsar Boulevard, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7717933777
Phone
+98 35 3626 0001
Fax
+98 34 3211 5783
Email
shafahospital@kmu.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Dr.Hamid Hakimi
Street address
Central Organization, Imam Ali Blvd, Rafsanjan
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0028
Fax
Email
info@rums.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rafsanjan 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
Rafsanjan University of Medical Sciences
Full name of responsible person
Ahmad Salehi Derakhtanjani
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Al-Zahra Sub, Alley No12, Hakim St, Kerman
City
Kerman
Province
Kerman
Postal code
7615977118
Phone
+98 343315007
Email
Ahmadsalehi2117@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Tayebeh Negahban
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Central Organization, Imam Ali Blvd, Rafsanjan
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0038
Email
negahbant@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Shahin Heydari
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Central Organization, Blvd Imam Ali, Rafsanjan
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0038
Email
Kermanshah3252@yahoo.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
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available