Protocol summary

Summary
This study is conducted for evaluating the effect of preoperative respiratory exercise on pulmonary complication in patients undergoing Coronary artery bypass surgery in Kowthar Hospital. In this study 100 patients who are candidate for CABG randomly allocated to groups of experiment and control. Patients who have 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 and directed cough maneuvers 3 days before operation. This breathing exercise is initiated one hour after extubation and will be done in the first four days after surgery, two times every day. Patients who are allocated in control group will receive the hospital routine treatment. For comparing the outcomes ABG and atelectasis in chest x ray will be compared. Arterial blood gasses and chest X ray will be compared preoperation and first, second and third day post operatively.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201404096778N5
Registration date: 2014-08-16, 1393/05/25
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-08-16, 1393/05/25
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
Baqiyyatallah university of medical sciences
Expected recruitment start date
2014-01-12, 1392/10/22
Expected recruitment end date
2014-03-12, 1392/12/21
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of preoperative respiratory exercises on pulmonary complications in coronary artery diseased patients After cardiac surgery
Public title
The effect of preoperative respiratory exercises on pulmonary complications after 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
From 30 years old to 80 years old
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
Baqiyyatallah University of medical sciences
Street address
Baghyattallah university of medical sciences, ُSheikh Bahaei St, Tehran
City
Tehran
Postal code
Approval date
2013-11-09, 1392/08/18
Ethics committee reference number
11/340/س

Health conditions studied

1

Description of health condition studied
Atelectasis
ICD-10 code
j98.1
ICD-10 code description
Collapse of lung

Primary outcomes

1

Description
Atelectasis
Timepoint
First, second and third day after surgery
Method of measurement
Chest X ray

Secondary outcomes

1

Description
saturation of arterial oxygen
Timepoint
First, second and third day after surgery
Method of measurement
arterial blood gas analysis

Intervention groups

1

Description
Patients who are allocated to experiment group will receive planned breathing exercises including deep breathing and directed cough maneuvers three days before operation.In every waking hour they will do five deep breathes following by five direct cough maneuvers.
Category
Prevention

2

Description
Patients who are allocated in control group will receive the hospital routine treatment. Any intervention is not done before surgery for this group of patients.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Kowsar Hospital
Full name of responsible person
Mrs Abolghasemi
Street address
Kowsar Hospital, Ghasroldasht St, Shiraz
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Nursing faculty, Baghiyatallah University of medical sciences
Full name of responsible person
Dr Abbas Ebadi
Street address
Baghiyatallah University of medical sciences, Sheykh Bahaei street, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Nursing faculty, Baghiyatallah 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
Nursing Faculty, Baqiyyatallah University Of medical Sciences
Full name of responsible person
Amir Abbas Heydari
Position
Master of science student
Other areas of specialty/work
Street address
Baghiyatallah University of medical sciences, Sheykh Bahaei street, Tehran Tehran
City
Tehran
Postal code
Phone
+98 21 2612 7278
Fax
Email
heydari1334@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
School of nursing, Baqiyyatallah UNiversity of Medical Sciences
Full name of responsible person
Seyed Tayeb Moradian
Position
Nursing Ph.D
Other areas of specialty/work
Street address
Baghiyatallah University of medical sciences, Sheykh Bahaei street, Tehran
City
Tehran
Postal code
Phone
+212 6127278
Fax
Email
t-moradian@razi.tums.ac.ir
Web page address

Person responsible for updating data

Contact

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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