Protocol summary

Summary
The aim of the study was evaluation of the effect of Pre and Post operation Breathing Exercise on the Incidence of atelectasis and pneumonia in patients with coronary artery bypass graft surgery referred to Seyed-Al-Shohada hospital situated in Urmia, Iran. The study started after approval of Local Ethics Committee comprised 40 patients candidate for CABG with the ages between 40-70 years old were at Seyed-Al-Shohada hospital, Urmia, Iran. Patients were randomly assigned to the control and experiment group. Patients with previous pulmonary surgery and cognitive disorders, congestive heart disease, and previous chronic pulmonary disease and intubation more than 24 hours were not included in the study. Patients studied in experiment group received breathing exercises including deep breathing, incentive spirometry and directed cough maneuvers. This breathing exercise was initiated 48 hours pre operation and then that were repeated at 24 and 72 hours after extubation after surgery. Patients in control group received the hospital routine treatment. For assessment of ABG outcomes, CBC, atelectasis and pneumonia in chest x ray and pulmonary function testes were compared in all patients. Arterial Blood Gasses and blood sampling and chest X ray between two groups were compared pre operation and first and third day post operation.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201209229422N3
Registration date: 2012-09-28, 1391/07/07
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2012-09-28, 1391/07/07
Registrant information
Name
Aram Feizi
Name of organization / entity
Urmia University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 44 1336 5836
Email address
aramfeizi@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Urmia University of Medical Sciences
Expected recruitment start date
2012-06-21, 1391/04/01
Expected recruitment end date
2012-09-10, 1391/06/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the effect of pre and post operation breathing exercise on the incidence of atelectasis and pneumonia in patients with coronary artery bypass graft surgery who referred to Seyed-al-shohada hospital, Urmia
Public title
The effect of pre and post operation breathing exercise on the incidence of atelectasis and pneumonia in patients with coronary artery bypass graft surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Patients between 40-70 years old, ejection fraction negative history muscular or cognitive disorders; no emergency surgery; negative history of previous heart surgery, lack of preoperative pulmonary disease (pneumonia, chronic obstructive pulmonary disease, atelectasis, pleural effusion). Exclusion criteria: need for mechanical ventilation more than 24 hour, need for reoperation due to surgery complications; Patient refusal of further participation in the study at any stage of the work; congestive heart disease, severe hemodynamic impairment.
Age
From 40 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
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
Urmia University of Medical Sciences
Street address
Urmia University of Medical Sciences, Resalat Boulevard
City
urmia
Postal code
Approval date
2012-05-29, 1391/03/09
Ethics committee reference number
6/91/4/39220پ

Health conditions studied

1

Description of health condition studied
Coronary artery disease
ICD-10 code
I25.1
ICD-10 code description
Atherosclerotic heart disease

Primary outcomes

1

Description
atelectasis
Timepoint
24 and 72 hours after extubation after surgery
Method of measurement
chest x ray ,pulmonary function testes،arterial blood gasses

2

Description
pneumonia
Timepoint
24 and 72 hours after extubation after surgery.
Method of measurement
chest X ray, blood sampling

3

Description
pulmonary function
Timepoint
48 hours pre operation،72 hours after extubation after surgery
Method of measurement
pulmonary function testes, Arterial Blood Gasses

Secondary outcomes

1

Description
Saturation of Peripheral Oxygen
Timepoint
preoperation and 72 hours after extubation after surgery
Method of measurement
monitor and pulse oximetry

2

Description
arterial blood gasses
Timepoint
preoperation,24 and 72 hours after extubation
Method of measurement
assessment arterial blood gas

3

Description
tempereture
Timepoint
preoperation,24 and 72 hours after extubation
Method of measurement
by termometer

4

Description
respiratory rate
Timepoint
preoperation,24 and 72 hours after extubation
Method of measurement
number of respiratory rate

5

Description
heart rate
Timepoint
preoperation,24 and 72 hours after extubation
Method of measurement
cardiac monitoring

Intervention groups

1

Description
Experiment group received breathing exercises including deep breath, incentive spirometry and directed cough maneuvers.These breathing exercises was initiated one hour after extubation and were repeated in the first and three days after extubation after surgery.
Category
Prevention

2

Description
Control group received the hospital routine treatment.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Seyyed-o-alshohada Hospital
Full name of responsible person
Dr. Shahyad Salehi Ardebili
Street address
Seyyed-o-alshohada Hospital, 17 Shahrivar Street, Urmia
City
urmia

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Urmia University of Medical Sciences
Full name of responsible person
Dr. Morteza Motazaker
Street address
Urmia University of Medical Sciences
City
urmia
Grant name
ردیف پژوهشی معاونت تحقیقات و فن آوری
Grant code / Reference number
1094
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Urmia University of Medical Sciences
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
Name of organization / entity
Urmia University of Medical Sciences
Full name of responsible person
Dr. Aram Feizi
Position
PhD of Nursing
Other areas of specialty/work
Street address
Nursing and Midwifery Faculty, Urmia University of Medical Sciences
City
urmia
Postal code
Phone
+98 44 1275 2917
Fax
Email
aramfeizi@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Urmia University of Medical Sciences
Full name of responsible person
Dr. Aram Feizi
Position
PhD of Nursing
Other areas of specialty/work
Street address
Medical Education Development Center, Urmia University of Medical Sciences
City
urmia
Postal code
Phone
+98 44 1293 7300
Fax
Email
aramfeizi@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Nursing and Midwifery Faculty
Full name of responsible person
Aisona Rahmani
Position
MSc Student of Nursing
Other areas of specialty/work
Street address
Nursing and Midwifery Faculty, Urmia University of Medical Sciences
City
urmia
Postal code
Phone
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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