The impact of planned breathing exercise on respiratory complication in patients after coronary artery bypass surgery in Shahid Rajaei training, research and treatmtnt heart center
This study is conducted for evaluating the effect of planned breathing exercises on pulmonary complication in patients undergoing Coronary artery bypass surgery in Shahid Rajaei Heart Center. In this study 100 patients who are candidate for CABG randomly allocated to groups of experiment and control. Patients who had emergency surgery and neuromuscular and cognitive disorders will not be studied. Patients who are allocated in experiment group will receive planned breathing exercises including deep breathing, incentive spirometr and directed cough maneuvers. This breathing exercise is initiated one hour after extubation and will be done in the first four days after surgery. Patients who are allocated in control group will receive the hospital routine treatment. For comparing the outcomes ABG, atelectasis in chest x ray and distance walked in 6 minute will be compared. Arterial blood gasses and chest X ray will be compared pre operation and first, second and third day post operatively.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201106126778N1
Registration date:2011-06-25, 1390/04/04
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-06-25, 1390/04/04
Registrant information
Name
Seyed Tayeb Moradian Vafaei
Name of organization / entity
School of nursing and midwifery, Tehran university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2303 4258
Email address
t-moradian@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
School of Nursing and Midwifery of Tehran University of Medical Sciences Research Center
Expected recruitment start date
2010-12-22, 1389/10/01
Expected recruitment end date
2011-03-22, 1390/01/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The impact of planned breathing exercise on respiratory complication in patients after coronary artery bypass surgery in Shahid Rajaei training, research and treatmtnt heart center
Public title
Planned breathing exercises and reducing the pulmonary complications in patients undergoing coronary artery bypass graft surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Incluson criteria: Negative history of neurological disorders; muscular or cognitive disorders; no emergency surgery; negative history of previous CABG; Lack of preoperative pulmonary disease (pneumonia, chronic obstructive pulmonary disease, atelectasis, pleural effusion and asthma); the ability to perform planned breathing exercises; negative history of severe renal dysfunction)
Exclusion criteria: need for mechanical ventilation more than 24 hour; need for reopration due to surgery complications; Patient refusal of further participation in the study at any stage of the work; incidence of cognitive and neurological disorders after surgery; severe hemodynamic impairment
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
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
School of nursing and midwifery, Tehran University of Medical Sciences
Street address
School of Nursing and Midwifery, Towhid Square
City
Tehran
Postal code
Approval date
2010-11-21, 1389/08/30
Ethics committee reference number
250.522
Health conditions studied
1
Description of health condition studied
Atelectasis
ICD-10 code
J98.1
ICD-10 code description
Pulmonary collapse
Primary outcomes
1
Description
Atelectasis
Timepoint
Daily
Method of measurement
Chest x ray
Secondary outcomes
1
Description
Phyasical function
Timepoint
the fourth day after intervention
Method of measurement
six minute walking test
Intervention groups
1
Description
Patients who are allocated to control group will receive the hospital routine treatment
Category
Prevention
2
Description
Patients who are allocated to experiment group will receive planned breathing exercises including deep breathing, incentive spirometer and directed cough maneuvers. This breathing exercise is initiated one hour after extubation and will be done in the first four days after surgery.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Sahahid Rajaei education, research and therapy center
Full name of responsible person
Dr Majid Haghgoo
Street address
the intersection Niayesh, Vali Asr Street
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
School of Nursing and Midwifery of Tehran University of Medical Sciences Research Center
Full name of responsible person
Dr Neda Mehrdad
Street address
School of Nursing and Midwifery, Towhid Square
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
School of Nursing and Midwifery of Tehran University of Medical Sciences Research Center
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
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of nursing and midwifery, Tehran University of Medical Sciences
Full name of responsible person
Seyed Tayeb Moradian
Position
MSc student of critical care nursing
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Towhid Square
City
Tehran
Postal code
Phone
+98 989123781448
Fax
Email
t-moradian@razi.tums.ac.ir, t.moradyan@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)