Effect of intermittent inspiratory and expiratory incentive spirometry on pulmonary complications of patients undergoing coronary artery bypass graft surgery in patients admitted to intensive care unit of Hamadan heart center in 1397
Determination of the effect of alternating motivational spirometry and exhalation on pulmonary complications of patients undergoing coronary artery bypass graft surgery
Design
Randomized clinical trial with two groups and parallel group design
Settings and conduct
This study is a randomized clinical trial on 66 patients admitted to intensive care units in Hamadan Heart Hospital. In intervention group, patients who will be under alternating motivational inspiration and expiration spirometry will be trained to provide spirometry from 8.AM to 8.PM every two hours up to 10 times, alternately, 2 hours for inspiration and 2 hours for expiratory spirometry. Patients require continuing to do spirometry from the second day until the fifth day after surgery. In control group, no further action will be taken except routine care.
Participants/Inclusion and exclusion criteria
Inclusion criteria: The ability to use a motivational spirometric device; Mechanical ventilation less than 24 hours. Non inclusion criteria: having severe preoperative pulmonary disease (such as chronic obstructive pulmonary disease)
Intervention groups
Intervention group: patients who will be under alternating motivational inspiration and expiration spirometry will be trained to provide spirometry from 8.AM to 8.PM every two hours up to 10 times, alternately, 2 hours for inspiration and 2 hours for expiratory spirometry. Patients require continuing to do spirometry from the second day until the fifth day after surgery. Control group: no further action will be taken except routine care.
Main outcome variables
Atelectasis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160110025929N18
Registration date:2018-12-14, 1397/09/23
Registration timing:prospective
Last update:2018-12-14, 1397/09/23
Update count:0
Registration date
2018-12-14, 1397/09/23
Registrant information
Name
Mehdi Molavi Vardanjani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3422 5056
Email address
m.molavi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-22, 1397/10/01
Expected recruitment end date
2019-12-22, 1398/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of intermittent inspiratory and expiratory incentive spirometry on pulmonary complications of patients undergoing coronary artery bypass graft surgery in patients admitted to intensive care unit of Hamadan heart center in 1397
Public title
Effect of intermittent inspiratory and expiratory incentive spirometry on pulmonary complications
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Mechanical ventilation less than 24 hours
The ability to use a motivational spirometric device
Exclusion criteria:
Having severe preoperative pulmonary disease (such as chronic obstructive pulmonary disease)
Severe hemodynamic disorders (such as severe hypertension or shock, shock)
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
Randomization description
Samples will be divided into two experimental and control groups based on permutation block randomization method (blocks of size 4). It will be listed according to six possible ways (AABB, ABAB, ...) randomly.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Shahid Fahmideh street
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Approval date
2018-11-03, 1397/08/12
Ethics committee reference number
IR.UMSHA.REC.1397.526
Health conditions studied
1
Description of health condition studied
Coronary artery disease
ICD-10 code
I25.1
ICD-10 code description
Atherosclerotic heart disease of native coronary artery
Primary outcomes
1
Description
Atelectasis
Timepoint
Before and after intervention
Method of measurement
Chest X-ray
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: patients who will be under alternating motivational inspiration and expiration spirometry will be trained to provide spirometry from 8.AM to 8.PM every two hours up to 10 times, alternately, 2 hours for inspiration and 2 hours for expiratory spirometry. Patients require continuing to do spirometry from the second day until the fifth day after surgery.
Category
Prevention
2
Description
Control group: no further action will be taken except routine care.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Farshchian hospital
Full name of responsible person
Reza Borzou
Street address
Shahid Fahmideh sreet
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
borzou@umsha.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Saeed Bashirian
Street address
Shahid Fahmideh street
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
s-bashirian@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Deputy of research and technology, Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Reza Borzou
Position
Assisstant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahid Fahmideh street
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
borzou@umsha.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Reza Borzou
Position
Assisstant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahid Fahmideh street
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
borzou@umsha.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Zahra Sabzyani
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Shahid Fahmideh street
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
Zahrasabzyani2013@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
Not applicable
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