Protocol summary

Summary
Now a day all known the main roles of nursing groups in open heart surgery wards and improvement in their working basically decrease the patient’s mortality and morbidity the goal of this research study is evaluation of the effects of respiratory training patient’s education before operation on patients respiratory function after open heart surgery. Methods: This study after approved Local Ethics Committee comprised 80 patients in age 45-65 years old that underwent coronary artery bypass graft (CABG) in Ekbatan Hospital of Hamadan, Iran. Patients were randomly assigned into two groups equally (case and control groups each group 40). Inclusion criteria include: All patients 45-65 years old range without any chronic disease. Exclusion criteria include to event penumothorax and re intubation due to acute respiratory failure. Both of groups will evaluate of pulmonary Function Test before operation case grope have planned series training during 2.5 hours and continue this training after operation in control group will do this training just after operation. The programs for pulmonary tests in both groups will do Chest X-Rays, listening to breath sound, detect deep of respiration ,respiratory rates, pulse rates, Temperature,SPO2and ABG in a detected range of hours in 1,2,3 days after operation .

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201112188451N1
Registration date: 2012-07-26, 1391/05/05
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2012-07-26, 1391/05/05
Registrant information
Name
Atefeh Boostanbakhsh
Name of organization / entity
Hamedan University Of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 81 1823 3310
Email address
a.boostan@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
HAMEDAN UNIVERSITY OF MIDICAL SCIENCE
Expected recruitment start date
2012-01-05, 1390/10/15
Expected recruitment end date
2012-03-20, 1391/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment the effects of respiratory exersise education before surgery on patient’s pulmonary function after open heart surgery
Public title
Effect of respiratory physiotherapy on pulmonary function
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: open heart surgery; age 45 to 65; patient satisfaction, lack of acute and chronic lung disease; having pft acceptable and normal, having a normal chest Exclusion criteria: lack of patient satisfaction; pneumothorax; advanced lung infection; referred back to the operating room; the incidence of adverse events after surgery;prolonged surgical procedures; re-intubation; pulmonary embolism; pleural effusion; pulmonary edema; emphysema
Age
From 45 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 80
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
HAMEDAN UNIVERSITY OF MEDICAL SCIENCE
Street address
HAMEDAN MAHDIYEH S. NEAR THE MARDOM PARK
City
HAMEDAN
Postal code
Approval date
2012-11-13, 1391/08/23
Ethics committee reference number
2854/35/16/پ/د

Health conditions studied

1

Description of health condition studied
CRONARY HEART DISEASE AND VALVE DISEASE
ICD-10 code
I25.1
ICD-10 code description
Atherosclerotic heart disease

Primary outcomes

1

Description
HEAR RATE
Timepoint
BEFORE OF SURGERY AND AFTER SURGERY PER 2 HR AND PER 6 HR AND PER 12 HR AND THURSE DAY
Method of measurement
CARDIAC MONITORING

2

Description
DEEP OF RESPIRATION
Timepoint
BEFORE OF SURGERY AND AFTER SURGERY PER 2 HR AND PER 6 HR AND PER 12 HR AND THURSE DAY
Method of measurement
WHIT OBSERVATION

3

Description
RESPIRATORY RATE
Timepoint
BEFORE OF SURGERY AND AFTER SURGERY PER 2 HR AND PER 6 HR AND PER 12 HR AND THURSE DAY
Method of measurement
NUMBER OF RESPIRATORY RATE

4

Description
Saturation of Peripheral Oxygen
Timepoint
BEFORE OF SURGERY AND AFTER SURGERY PER 2 HR AND PER 6 HR AND PER 12 HR AND THURSE DAY
Method of measurement
MONITOR AND PULSE OXIMETRY

5

Description
TEMPERETURE
Timepoint
BEFORE OF SURGERY AND AFTER SURGERY PER 2 HR AND PER 6 HR AND PER 12 HR AND THURSE DAY
Method of measurement
BY TERMOMETER

6

Description
PULMONARY SOUND
Timepoint
BEFORE OF SURGERY AND AFTER SURGERY PER 2 HR AND PER 6 HR AND PER 12 HR AND THURSE DAY
Method of measurement
AUSCULATION

7

Description
chest x-ray
Timepoint
BEFORE OF SURGERY AND AFTER SURGERY PER 2 HR AND PER 6 HR AND PER 12 HR AND THURSE DAY
Method of measurement
CHEEST RADIOGRAPHY

8

Description
atrial blood gas
Timepoint
BEFORE OF SURGERY AND AFTER SURGERY PER 2 HR AND PER 6 HR AND PER 12 HR
Method of measurement
ASSESSMENT ATRIAL BLOOD GAS

Secondary outcomes

1

Description
PNEMOTHORAXS
Timepoint
DURING TO RESEARCH
Method of measurement
CXR

Intervention groups

1

Description
Case Group: Patients divided in groups 3-5 person respiratory training (diaphragmatic respiration, incentive Respirametry and effective Cough and…) will do practical and face to face in 2 times 2.5 hours 2 days before operation. If patients don't learn repeat the programs and the patients with low function will be deleted of study.
Category
Prevention

2

Description
Control Group: in This group Educational training Will be done 2 days after operation routinely .
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
EKBATAN HOSPITAL OPEN HEART SURGERY
Full name of responsible person
MOHSEN SALAVATI
Street address
HAMEDAN MAHDIYE S. NEAR MARDOM PARK
City
HAMEDAN

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Hamedan University Of Medical Science
Full name of responsible person
Heydar Tavilani
Street address
Near Mardom Park, Mahdiye ST, Hamedan
City
Hamedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan University Of Medical Science
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
Hamedan University Of Medical Science
Full name of responsible person
ATEFEH BOOSTANBAKHSH
Position
Master Science Critical Nurse Student
Other areas of specialty/work
Street address
Open Heart Surgery, Ekbatan Hospital, Hamedan
City
Hamedan
Postal code
Phone
+98 81 1835 2041
Fax
Email
a.boostan@umsha.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamedan University Of Medical Science
Full name of responsible person
MOHSEN SALAVATI
Position
MSN
Other areas of specialty/work
Street address
Near Mardom Park, Mahdiye St, Hamedan
City
Hamedan
Postal code
65178-3-8698
Phone
+98 81 1838 0150
Fax
Email
SALAVATI@umsha.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Hamedan University Of Medical Science
Full name of responsible person
ATEFEH BOOSTANBAKHSH
Position
Master Science Critical Nurse Student
Other areas of specialty/work
Street address
Near Mardom Park, Mahdiye St, Hamedan
City
HAamedan
Postal code
65178-3-8698
Phone
+98 81 1823 3310
Fax
Email
A.BOOSTAN@umsha.ac.ir
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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