Comparison between continuous lung ventilation at low minute volume and non-ventilation during pumping in oxygenation and extubation in patients undergoing coronary bypass surgery
Objective: Comparison between continuous lung ventilation at low minute volume and non-ventilation during pumping in oxygenation and extubation in patients undergoing coronary bypass surgery.
Design: Randomized, single blind (researchers were unaware), Target sample size: 30 People from patients undergoing coronary bypass surgery.
The main inclusion criteria: Male and female candidates for elective coronary artery bypass surgery; Consent to participate in the study; The age range of 40-75 years; Body mass index (BMI)) less than 30.
The main exclusion criteria: Underlying lung disease; Previous history of diabetes; Pulmonary blood pressure; Grade 2 (or higher) diastolic dysfunction; previous history of surgery or CABG surgery; Ejection fraction (EF) less than 30%; Pumping time more than 2 hours; Long ventricular fibrillation or prolonged heart massage during surgery; Other factors causing prolonged ventilation.
Intervention group: Patients with continuous ventilation of the lungs with low minute volume, with a tidal volume of 4 ml/ kg and a respiratory rate of 12 per minute during cardiopulmonary bypass pump.
Control group: Patients without ventilation, after connecting to cardiopulmonary bypass pump, oxygen and ventilation are disconnected and oxygenation of the patient's blood occurs through a bypass pump (CPB).
Primary outcome measure: Oxygen Pressure in arterial blood and Fraction of Inspired Oxygen, Before induction and after intubation and before starting the pomp, during and after removal the pomp at the end of surgery, by Arterial blood test.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014042513159N4
Registration date:2014-05-17, 1393/02/27
Registration timing:prospective
Last update:
Update count:0
Registration date
2014-05-17, 1393/02/27
Registrant information
Name
Shima Sheybani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3764 7230
Email address
sheybanish@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Mashhad University of Medical Sciences
Expected recruitment start date
2014-06-01, 1393/03/11
Expected recruitment end date
2015-06-01, 1394/03/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between continuous lung ventilation at low minute volume and non-ventilation during pumping in oxygenation and extubation in patients undergoing coronary bypass surgery
Public title
Improvement in Pulmonary parameters in patients during and after coronary bypass surgery
Purpose
Treatment
Inclusion/Exclusion criteria
The main inclusion criteria: Male and female candidates for elective coronary artery bypass surgery; Consent to participate in the study; The age range of 40-75 years; Body mass index (BMI)) less than 30.
The main exclusion criteria: Underlying lung disease; Previous history of diabetes; Pulmonary blood pressure; Grade 2 (or higher) diastolic dysfunction; previous history of surgery or CABG surgery; Ejection fraction (EF) less than 30%; Pumping time more than 2 hours; Long ventricular fibrillation or prolonged heart massage during surgery; Other factors causing prolonged ventilation.
Age
From 45 years old to 75 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Male and female candidates for undergone elective coronary bypass surgery on- pump, are divided into two groups of 15, based on a random table. Extubation in patients is scheduled by a nurse who is unaware about research.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Vice Chancellor for Research, Mashhad University of Medical Sciences, Ghoreishi building, Daneshgah Street, Mashhad
City
Mashhad
Postal code
Approval date
2013-11-20, 1392/08/29
Ethics committee reference number
920273
Health conditions studied
1
Description of health condition studied
Pulmonary heart disease
ICD-10 code
I27.9
ICD-10 code description
Pulmonary heart disease, unspecified
Primary outcomes
1
Description
Oxygen Pressure in arterial blood
Timepoint
Before, During and after anesthesia
Method of measurement
Arterial blood test
2
Description
Fraction of Inspired Oxygen
Timepoint
Before, during and after anesthesia
Method of measurement
Arterial blood test
Secondary outcomes
1
Description
Point atelectasis
Timepoint
In ICU after intervention
Method of measurement
Chest radiograph
Intervention groups
1
Description
Intervention group: patients with continuous ventilation of the lungs with low minute volume, with a tidal volume of 4 ml/ kg and a respiratory rate of 12 per minute during cardiopulmonary bypass pump
Category
Treatment - Other
2
Description
Control group: Patients without ventilation, after connecting to cardiopulmonary bypass pump, oxygen and ventilation are disconnected and oxygenation of the patient's blood occurs through a bypass pump (CPB).
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem Hospital
Full name of responsible person
Shima Sheybani
Street address
Ghaem hospital, Ahmadabad Avenue, Mashhad
City
Mashhad
2
Recruitment center
Name of recruitment center
Shariati Hospital
Full name of responsible person
Shima Sheybani
Street address
Shariati hospital, Three ways of Torghabe-Shandiz, Zaferanieh Blv, Mashhad
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Vice Chancellor for Research, Mashhad University of Medical Sciences, Ghoreishi building, Daneshgah Street, Mashhad
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Shima Sheybani
Position
Assistant Professor
Other areas of specialty/work
Street address
Anesthesia Department, Ghaem Hospital, Mashhad
City
Mashhad
Postal code
Phone
+98 51 1801 2612
Fax
Email
sheybanish@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Shima Sheybani
Position
Assistant Professor
Other areas of specialty/work
Street address
Anesthesia Department, Ghaem Hospital, Mashhad
City
Mashhad
Postal code
Phone
+98 51 1801 2612
Fax
Email
sheybanish@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Shima Sheybani
Position
Assistant Professor
Other areas of specialty/work
Street address
Anesthesia Department, Ghaem Hospital, Mashhad
City
Mashhad
Postal code
Phone
+98 51 1801 2612
Fax
Email
sheybanish@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)