Protocol summary

Summary
The main objective of this study is to determine the effect of incentive spirometry , knowing oxygenation in patients after coronary artery bypass graft surgery . Inclusion criteria : elective coronary artery bypass graft surgery; coronary artery bypass graft surgery is not an emergency; no history of previous coronary artery bypass graft surgery; no neurological disorders - muscular or cognitive impairments; pulmonary disease; ability Spirometry; written and informed consent to participate in the study. Exclusion criteria : congestive heart failure; severe respiratory failure; reoperation;sternal infection; need for mechanical ventilation for more than 48 hours;the patient died. The study sample of 70 patients candidat coronary artery disease surgery were randomly divided into two groups will perform. Spirometry was used in the intervention group and in the hospital routine will be applied. Expect to use incentive spirometry is effective in improving oxygenation in patients.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013102015073N1
Registration date: 2013-11-16, 1392/08/25
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2013-11-16, 1392/08/25
Registrant information
Name
Mohammad Hadi Zahmatkesh Saredorahy
Name of organization / entity
Yazd University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 35 1523 2241
Email address
hadizahmatkesh@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Council of Yazd University of Medical Sciences
Expected recruitment start date
2013-11-01, 1392/08/10
Expected recruitment end date
2013-12-31, 1392/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of incentive spirometry, knowing oxygenation in patients after coronary artery bypass surgery
Public title
The effect of incentive spirometry, knowing oxygenation in patients after coronary artery bypass surgery
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: elective coronary artery bypass graft surgery; coronary artery bypass graft surgery is not an emergency; no history of previous coronary artery bypass graft surgery; no neurological disorders - muscular or cognitive impairment; preoperative pulmonary disease lack the ability Spirometry performed; ventricular ejection fraction greater than 35% of output; written informed consent to participate in the study. Exclusion criteria: congestive heart failure; severe respiratory failure; reoperation; sternal infection; need for mechanical ventilation for more than 48 hours; the patient died.
Age
From 18 years old to 90 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 70
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
Yazd University of Medical Sciences
Street address
Headquarters Yazd University, Bahonar Square,Yazd
City
Yazd
Postal code
8916877443
Approval date
2013-09-03, 1392/06/12
Ethics committee reference number
104943/1/17/پ

Health conditions studied

1

Description of health condition studied
Coronary Atrial Bypass Graft Pations
ICD-10 code
I25.1
ICD-10 code description
Atherosclerotic heart disease

Primary outcomes

1

Description
Arterial Blood Gas values
Timepoint
Before induction of anesthesia in the operating room, the first and second day after surgery
Method of measurement
Arterial blood gas sample get in the time scales considered and this is analyzed using Nova Biomedichal machine

Secondary outcomes

empty

Intervention groups

1

Description
In the intervention group:24 hours before surgery and use of incentive spirometry device is functioning properly , the patient was given a full explanation by the researcher from the patient will be asked to perform incentive spirometry . Then ensure the appropriate use of spirometry incentive،after coronary artery bypass graft surgery patients were extubated after a time , she/he began spirometry and 10 times per hour at the time, thus awakening a deep breath spirometry done about 2 seconds, then exhale and hold to do. between each time we do rest about 10 seconds .
Category
Rehabilitation

2

Description
In Ontrol group: Routine is applied in hospitals for patients who have already attempted before surgery is performed after the operation policy for the use of Spirometry including frequency of use, monitor used is not correct.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Afshar Hospital Yazd
Full name of responsible person
Mrs. H. Dehghani
Street address
Yazd University of Medical Sciences, School of Nursing
City
Yazd

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research Council of Yazd University of Medical Sciences
Full name of responsible person
Dr.f.Ezoddin
Street address
Research Council of Yazd University of Medical Sciences
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Council of Yazd 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
Yazd University of Medical Sciences, School of Nursing
Full name of responsible person
Mohammad Hadi Zahmatkesh Saredorahy
Position
Student nurse in master of critical care nursing
Other areas of specialty/work
Street address
Afshar hospital, Jomhuory Boulevard,yazd,iran
City
Yazd
Postal code
8916877443
Phone
+98 35 1523 2241
Fax
Email
hadizahmatkesh@ssu.ac.ir،hadizahmatkesh@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Mrs. H. Dehghani
Position
Bachelor of Nursing
Other areas of specialty/work
Street address
School of Nursing, St Bou Ali, Boulevard Brigadier Fallahi,yazd,iran
City
Yazd
Postal code
8916877443
Phone
+98 35 1824 1751
Fax
Email
hamide.Dehghani@ yahoo . com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Yazd University of Medical Sciences, School of Nursing
Full name of responsible person
Mohammad Hadi Zahnatkesh Saredorahy
Position
Student nurse in master of critical care nursing
Other areas of specialty/work
Street address
Afshar hospital,Jomhuory Boulvar,Yazd,Iran
City
Yazd
Postal code
8916877443
Phone
+98 35 1523 2241
Fax
Email
hadizahmatkesh@ssu.ac.ir،hadizahmatkesh@yahoo.com
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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