Protocol summary

Study aim
Effect of training on correction of respiratory patterns on capnometric indices and respiratory function in patients undergoing coronary artery bypass graft surgery
Design
This study was a randomized, blind clinical trial with two intervention and control groups. Each group included 10 patients.
Settings and conduct
The number of participants in this pilot study is 20, 10 in each control and intervention group. Participants are patients who undergoing coronary artery bypass graft surgery in heart hospitals affiliated to Ahwaz University of Medical Sciences. Patients are grouped randomly using a random number table. Routine respiration before and after surgery are given to the intervention and control groups. in addition, before and after surgery, the correction of respiratory patterns are given to the intervention group.
Participants/Inclusion and exclusion criteria
Inclusion criteria:   Cardiac patients referring to hospitals affiliated to Jondishapour University of Ahwaz . Exclusion criteria: People with any chronic and acute respiratory discomfort, Heart troubles, kidney problems and autonomic nerve diseases
Intervention groups
In this study, candidates for coronary artery bypass surgery eligible for this study are selected randomly. Patients in the intervention group undergo respiratory physiotherapy before and after surgery as well as correction of respiratory pattern before and after surgery and In the control group, routine respiratory physiotherapy is performed before and after surgery.
Main outcome variables
Evaluation of blood acidity balance index by measuring arterial carbon dioxide pressure and arterial oxygen pressure in cardiac patients.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180216038748N1
Registration date: 2018-05-05, 1397/02/15
Registration timing: registered_while_recruiting

Last update: 2018-05-05, 1397/02/15
Update count: 0
Registration date
2018-05-05, 1397/02/15
Registrant information
Name
jeida shirali
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 17 3442 3390
Email address
shirali.j@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-04, 1397/01/15
Expected recruitment end date
2018-05-20, 1397/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of training on correction of respiratory patterns on capnometric indices and respiratory function in patients undergoing coronary artery bypass graft surgery
Public title
Effect of training on correction of respiratory patterns in cardiac patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Cardiac patients referring to hospitals affiliated with Jondishapour University of Ahwaz (Golestan and Imam) who are candidates for coronary artery bypass graft surgery
Exclusion criteria:
People with any chronic and acute respiratory discomfort Heart valve abnormalities history of musculoskeletal disorders affecting the respiratory pattern of patients Failure and kidney disease, heart failure and heart disease people with pace maker Use of a respiratory aids after surgery for longer than 24 hours and autonomic nerve dysfunctions
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 20
Randomization (investigator's opinion)
Randomized
Randomization description
This study will be conducted as a randomized, clinical trial. In this study, patients who are candidates for coronary artery bypass surgery who are eligible for this study are selected by the relevant cardiac surgeon guide. Then, by studying their case, the same patients are selected according to the main morphological indexes such as height, weight, body mass index, age, sex, type of surgery. In the next step, the selected patients in the last step are grouped to the intervention and control table by statistician expert advices , randomly. Each patient is assigned a number and these numbers are included randomly in random numbers using the software. Ultimately, patients are randomly assigned to each of the intervention and control groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, patients who are candidates for coronary artery bypass surgery who are eligible for this study are selected by the relevant cardiac surgeon guide. Then, by studying their case, the same patients are selected according to the main morphological indexes such as height, weight, body mass index, age, sex, type of surgery. In the next step, the selected patients in the last step are grouped to the intervention and control table by statistician expert advices , randomly . Finally, the complete and prerequisite explanations are provided to patients regarding to the purpose of this research project and the absence of any risks and side effects ,So the written consent form will filled in by the patients.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Ahwaz University of Medical Sciences
Street address
Ahwaz,golestan Ave, Jondishapour University of Medical Sicence
City
Ahwaz
Province
Khouzestan
Postal code
61357-15794
Approval date
2018-01-23, 1396/11/03
Ethics committee reference number
ir.ajums.rec.1396.910

Health conditions studied

1

Description of health condition studied
cardiac patients undergoing coronary artery bypass graft surgery
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
blood acidity changes
Timepoint
one day before surgery, immediately after the stability of the patient's vital signs after the surgical process and before the discharge of patients
Method of measurement
capnography

Secondary outcomes

1

Description
Effect of rate of respiratory rate per minute and depth of respiration in patients' quality of life
Timepoint
One day before the surgery, immediately afterwards the stability of the vital symptoms of later surgery, pre-dischargin from hospital
Method of measurement
capnography

Intervention groups

1

Description
In the intervention group for patients, in addition to a routine respiratory physiotherapy,the physiotherapy treatment of respiratory pattern correction before and after the surgery to determine its effect on respiratory indexes including pursed lip breathing with pause 2-5 seconds between the inspiration and expiraton, Buteyko respiratory corrective technique is performed.
Category
Rehabilitation

2

Description
In the control group, only routine respiratory physiotherapy is performed before and after surgery, including diaphragmatic breathing, training for the use of Incentive Spirometery, training Coughing to the patient and cupping and vibration techniques for discharge secretions chest.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Golestan hospital
Full name of responsible person
Jeida Shirali
Street address
Golestan hospital, Golestan blvd, Farvardin Ave , Ahwaz town
City
Ahwaz
Province
Khouzestan
Postal code
33118-61357
Phone
+98 61 9374 3001
Email
j_shiraly@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Badvi
Street address
Ahvaz jondishapur university medical science, Golestan Blvd,Ahwaz town
City
Ahwaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3373 8383
Email
info@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Jeida Shirali
Position
Masters student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Ahvaz univercity medical science,Golestan Blvd,Ahwaz Town
City
Ahwaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3374 3505
Email
j_shiraly@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Jeida Shirali
Position
Masters's Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Ahwaz univercity of medical science, Golestan Blvd, Ahwaz town
City
Ahwaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 17 3442 3390
Email
j_shiraly@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Jeida Shirali
Position
Masters Student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Ahwaz university of medical scienc, Golestan Blvd, Ahwaz town
City
Ahwaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 17 3442 3390
Email
shirali.j@ajums.ac.ir

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
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