Protocol summary

Summary
Objective: effect of deep breathing exercises and incentive spirometry on artery blood gases after coronary artery bypass surgery in open heart surgery critical care unit at Isfahan, Iran in 2012. Study Design: randomized clinical trial. Study population: patients admitted to open heart surgery intensive care unit hospital selective at Isfahan. Inclusion criteria: willingness to participate in the study; non emergency open heart surgery; not having mental and neuro-muscular disorders; not having any sever pulmonary disease(COPD); not having renal dysfunction; mechanical ventilation for less than 24 hours after admission to the open heart ICU and the ability in using of the incentive spirometry machine. Exclusion criteria: patients with hemodynamic instability (dangerous dysrhythmia, cardiogenic shock, sever hypotension) after surgery; having neurological and mental disorders after operation; the need for re-intubation or re-operation and willingness to quit the study. Intervention: first group used incentive spirometry, twice; group did deep breathing exercises and the control group did usual exercise (unplanned exercises). Time of intervention: interventions were performed for third day postoperative. Blood artery gases parameter (Sao2, Pao2, Paco2) were measured pre operative, after extubation, second and third days postoperative. The patient has arterial line after surgery until third postoperative for hemodynamic monitoring.

General information

Acronym
IS. DBE, CABG
IRCT registration information
IRCT registration number: IRCT2013050913280N1
Registration date: 2013-05-19, 1392/02/29
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-05-19, 1392/02/29
Registrant information
Name
Hiva Mohammadi Bollbanabad
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 87 2576 2431
Email address
h_mohamadi@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Isfahan University of Medical Sciences
Expected recruitment start date
2012-12-15, 1391/09/25
Expected recruitment end date
2013-02-18, 1391/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of deep breathing exercises and incentive spirometry on artery blood gases after coronary artery bypass surgery in open heart surgery critical care unit at Isfahan, 2012
Public title
The effect of breathing exercises on pulmonary function improvement after coronary artery bypass surgery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: willingness to participate in the study; non emergency open heart surgery; not having mental and neuro-muscular disorders; not having any sever pulmonary disease(COPD); not having renal dysfunction; mechanical ventilation for less than 24 hours after admission to the open heart ICU and the ability in using of the incentive spirometry machine. Exclusion criteria: patients with hemodynamic instability (dangerous dysrhythmia, cardiogenic shock, sever hypotension) after surgery; having neurological and mental disorders after operation; the need for re-intubation or re-operation and willingness to quit the study.
Age
From 40 years old to 90 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 75
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
Isfahan university of medical sciences
Street address
Faculty of Nursing and Midwifery, Isfahan University of Medical Sciences, Azadi Square, Hezar-Jerib,Isfahan
City
Isfahan
Postal code
461-81746
Approval date
2012-12-12, 1391/09/22
Ethics committee reference number
391339

Health conditions studied

1

Description of health condition studied
Coronary artery bypass surgery
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Blood artery gases parameter
Timepoint
Preperative, post extubation, second and third days postoperative
Method of measurement
Blood artery gases measurment machine

Secondary outcomes

empty

Intervention groups

1

Description
First group used incentive spirometry 10 per 2 hours.
Category
Prevention

2

Description
Intervention in second group consist of deep breathing exercises that are performed 10 per 2 hours.
Category
Prevention

3

Description
Control group only did usual exercises(unplanned exercises).
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Chamran hospital - Sina hospital
Full name of responsible person
Hiva mohammadi bollbanabad
Street address
bozorgmehr avenue-Isfahan
City
Ishahan

2

Recruitment center
Name of recruitment center
Sina hospital
Full name of responsible person
Hiva mohammadi bollbanabad
Street address
shams abadi avenue- Isfahan
City
Ishahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr Peiman Adibi
Street address
Isfahan University of Medical Sciences, Azadi Square, Hezar-Jerib street, Isfahan.
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan 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
Isfahan University of Medical Sciences
Full name of responsible person
Hiva Mohammadi Bollbanabad
Position
MSc student in critical care nursing
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Isfahan University of Medical Sciences, Azadi Square, Hezar-Jerib street, Isfahan
City
Isfahan
Postal code
73461-81746
Phone
+98 31 1792 2941
Fax
+98 73 4618 1746
Email
h_mohamadi@mui.ac.ir; hiva.nursing@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Ahmadreza Yazdannik
Position
PHD
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Isfahan University of Medical Sciences, Azadi Square, Hezar-Jerib street, Isfahan
City
Isfahan
Postal code
73461-81746
Phone
+98 31 1792 2941
Fax
Email
Yazdannik@nm.mui.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Hiva Mohammadi Bollbanabad
Position
MSc student in critical care nursing
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Isfahan University of Medical Sciences, Azadi Square, Hezar-Jerib
City
Isfahan
Postal code
73461-81746
Phone
+98 31 1792 2941
Fax
+98 31 1668 5145
Email
h_mohamadi@mui.ac.ir; hiva.nursing$@gmail.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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