Protocol summary

Summary
The aim of this study is evaluate the effect of ventilation during cardiopulmonary bypass on postoperative outcomes and pulmonary complications. Patients undergoing elective coronary artery bypass graft surgery with cardiopulmonary bypass are discussed. Exclusion criteria included patients with severe pulmonary disease before CABG and valve surgery in conjunction with coronary artery bypass grafting. After obtaining informed consent from the patient and perform routine monitoring and begin cardiopulmonary bypass patients were randomly allocated into two experimental or control groups. In the experimental group, intraoperative pulmonary ventilation with tidal volume of 3 -5 ml / kg and 11 breaths per minute continues and control group are in routine pulmonary ventilation discontinuation during bypass and put a breathing tube exposed to room air. Arterial blood gas variables and hemodynamic status at regular intervals during and after surgery is measured. After surgery we asses post operative outcomes such as tracheal extubation time, duration of ICU and hospital stay and of Atelectasis, pneumonia and pnomothorax based on chest X Ray and clinical evidence in both group. After recording the data, by using SPSS 16 we analysis them and evaluate the effect of ventilation on these variable.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014072418576N1
Registration date: 2014-10-31, 1393/08/09
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-10-31, 1393/08/09
Registrant information
Name
Fateme Hasanshiri
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 5554 0026
Email address
hasanshiri_fa@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kashan university of medical sciences and health services
Expected recruitment start date
2014-03-21, 1393/01/01
Expected recruitment end date
2014-09-23, 1393/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Pulmonary Ventilation on postoperative Outcomes and Pulmonary Complications after coronary artery bypass graft( CABG)
Public title
The Effect of Pulmonary Ventilation in coronary artery bypass graft( CABG)
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criterion: patients who are candidate for elective surgery of CABG. Exclusion criteria: severe pulmunary disease before surgery and valve surgery at the same time.
Age
From 18 years old to 99 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)
Double blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Kashan university of medical sciences and health services
Street address
Kashan university of medical sciences and health services. Kashan. IRAN
City
Kashan
Postal code
81511/87159
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
628/1/5/29/پ

Health conditions studied

1

Description of health condition studied
Pulmonary Ventilation during cardiopulmunary bypass on postoperative Outcomes and Pulmonary Complications
ICD-10 code
I25.9
ICD-10 code description
Chronic ischaemic heart disease, unspecified

Primary outcomes

1

Description
Pulmonary Ventilation on cardiopulmumery bypass
Timepoint
cardiopulmumery bypass
Method of measurement
number of breathing and tidal volume

Secondary outcomes

1

Description
postoperative Outcomes and Pulmonary Complications
Timepoint
after surgery
Method of measurement
evaluation of chest X ray

Intervention groups

1

Description
Pulmonary Ventilation during cardiopulmunary bypass in case group with respiratory rate 11\min and tidal volume 3- 5 ml\kg
Category
Prevention

2

Description
Disconnection from pulmonary ventilation during cardiopulmonary bypass in control group
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Beheshti Hospital, Open Heart Surgery Room
Full name of responsible person
Pourabbasi Mohamad Sadegh
Street address
Beheshti hospital. Kashan University of Medical Sciences, Kashan, Iran
City
Kashan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kashan University of Medical Sciences, Kashan, Iran
Full name of responsible person
Vice Chancellor for Research
Street address
87159/81151 Post Box,Ghotb ravandi Boulevard,Kashan University of Medical Sciences, Kashan, Iran
City
Kashan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan University of Medical Sciences, Kashan, Iran
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
Kashan University of Medical Sciences, Kashan, Iran
Full name of responsible person
Mohamad Sadegh Pourabbasi
Position
Assistant professor
Other areas of specialty/work
Street address
87159/81151 Post Box, Ghotb ravandi Boulevard, Kashan University of Medical Sciences, Kashan, Iran
City
Kashan
Postal code
Phone
+98 315540021
Fax
Email
drpourabbasi@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kashan University of Medical Sciences, Kashan, Iran
Full name of responsible person
Pourabbasi Mohamad Sadegh
Position
Assistant professor
Other areas of specialty/work
Street address
87159/81151 Post Box, Ghotb ravandi Boulevard, Kashan University of Medical Sciences, Kashan, Iran
City
Kashan
Postal code
Phone
+98 315540021
Fax
Email
drpourabbasi@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kashan University of Medical Sciences, Kashan, Iran
Full name of responsible person
Fateme Hasanshiri
Position
MSc of Nursing
Other areas of specialty/work
Street address
87159/81151 Post Box, Ghotb ravandi Boulevard,Kashan University of Medical Sciences, Kashan, Iran
City
Kashan
Postal code
Phone
+98 315540021
Fax
Email
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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