Protocol summary

Summary
This study aimed to compare the efficacy of respiratory care planning and Non-invasive ventilation with continuous positive airway pressure (CPAP) on the incidence of atelectasis and arterial blood oxygen levels in patients undergoing coronary artery bypass graft at Educational Affairs Rajai Cardiovascular Center. The present study is an empirical research in which the 120 patients undergoing coronary artery bypass graft with permuted-block randomization were given one of three groups (40 people) two intervention groups and a control group. (Inclusion criteria: no history of respiratory disease. not emergency heart surgery. Exclusion criteria: loss of consciousness after surgery, more than 24 hours of mechanical ventilation, hemodynamic instability). Patients in the first experimental group received a series of planned respiratory care, patients in the second experimental group received noninvasive ventilation and patients in control group were given routine hospital care. The other care were similar between the three groups of patients. Three groups were compared in terms of oxygen saturation prior to surgery and on the first, second and third postoperative atelectasis based on chest x-ray and as compared to the third day after surgery.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016050825707N3
Registration date: 2017-02-06, 1395/11/18
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-02-06, 1395/11/18
Registrant information
Name
Pouya Farokhnezhad Afshar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6347 1352
Email address
po.farokhnezhad@uswr.ac.ir
Recruitment status
Recruitment complete
Funding source
Educational Affairs Rajai Cardiovascular Center
Expected recruitment start date
2016-06-04, 1395/03/15
Expected recruitment end date
2016-07-31, 1395/05/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Compare the effects of respiratory care planning and non-invasive ventilation (CPAP) on the incidence of atelectasis and arterial blood oxygen levels in patients undergoing coronary artery bypass graft
Public title
effesct of ventilation interventions on the patient's breathing status
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: 1.with no history of respiratory disease 2. Age 30-70 years 3.not emergency heart surgery Exclusion criteria: 1. The patient's unwillingness to continue the study 2-loss of consciousness after surgery 3. more than 24 hours of mechanical ventilation 4. death of a patient 5. hemodynamic abnormalities 6.out of dreans in the time except the third day after surgery
Age
From 50 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 120
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
Rajaee cardiovascular center
Street address
Rajaee cardiovascular center.niayesh intersection.valiasr street
City
Tehran
Postal code
1996911151
Approval date
2016-02-27, 1394/12/08
Ethics committee reference number
RHC.AC.IR.REC.1394.34

Health conditions studied

1

Description of health condition studied
Atelectasis
ICD-10 code
J98.1
ICD-10 code description
Pulmonary collapse

Primary outcomes

1

Description
O2 saturation
Timepoint
3-4 times per day
Method of measurement
by puls oximeter and ABG

Secondary outcomes

1

Description
incidence of atelectasis
Timepoint
The third day post surgery
Method of measurement
CXR

Intervention groups

1

Description
Intervention group 1: 1) use of incentive spirometry for five-minute. 2)Three deep breathing that Contains a deep breath (to three mental count ) and exhale bud lips, and then do two effective cough. 3) Oral care with a solution of mouthwash or brush. 4))Undrestanding to repeat care. 5)movement, including changing position and moving the legs in the form of bicycles run, and by allowing the surgeon out of bed (for sitting on the edge of the bed, walking or Move with wheelchair). 6)The head of the bed elevated controlle at a rate of 45-30 degrees.
Category
Prevention

2

Description
Intervention group 2:applied Non-invasive ventilation by mask and with pressure 8-12 cm H2O for 20 minutes according to patient tolerance.
Category
Prevention

3

Description
Control group:Routine hospital care
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Rajaee cardiovascular center
Full name of responsible person
Sedighe Ghorbani
Street address
Niayesh intersection.valiasr street
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Rajaee cardiovascular center
Full name of responsible person
Sedighe Ghorbani
Street address
Shaheed Rajaei Cardiovascular Medical and Research Center Valiasr Ave Niayesh Intersection Tehran
City
Tehran
Grant name
....
Grant code / Reference number
...
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rajaee cardiovascular center
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
Rajaee cardiovascular center
Full name of responsible person
Sedighe Ghorbani
Position
BS/Nurse
Other areas of specialty/work
Street address
Shaheed Rajaei Cardiovascular Medical and Research Center Valiasr Ave, Niayesh Intersection, Tehran
City
Tehran
Postal code
1996911151
Phone
+98 21 7719 0467
Fax
Email
1357angrybird@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
University of Social Welfare and Rehabilitation Sciences
Full name of responsible person
Pouya Farokhnezhad Afshar
Position
PhD candidate
Other areas of specialty/work
Street address
kodakyar Ave., daneshjo Blvd., Evin, Tehran
City
Tehran
Postal code
1985713834
Phone
+98 22180083
Fax
+98 22180083
Email
Pouyafarokhnezhad@yahoo.com
Web page address
........

Person responsible for updating data

Contact
Name of organization / entity
Rajaee cardiovascular center
Full name of responsible person
Sedighe Ghorbani
Position
BS/Nurse
Other areas of specialty/work
Street address
Shaheed Rajaei Cardiovascular Medical and Research Center Valiasr Ave., Niayesh Intersection, Tehran
City
Tehran
Postal code
1996911151
Phone
+98 21 7719 0467
Fax
Email
1357angrybird@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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