The overall objective: to determine the effect of airway pressure release ventilation mode on hemodynamic parameters in patients after coronary artery bypass graft.
This study is a clinical trial with a crossover design. Subjects and randomly allocated based on the number of samples needed to be divided into two groups turns harmoniously.
Inclusion criteria: hemodynamic stability and EF> 40 and coronary artery bypass surgery without CPB is located on the pump. Exclusion criteria: shock, CPR and bleeding more than usual. The study sample size is 32 patients in two groups of 16 students. Intervention study, the position of the mode APRV mode for up to half an hour, compared with SIMV / PSV desired parameters to be measured. Expected outcome: patient's hemodynamic status is unchanged.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013092414756N1
Registration date:2015-01-17, 1393/10/27
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-01-17, 1393/10/27
Registrant information
Name
Samaneh Zakeri
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1270 0636
Email address
zakeris2@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2014-11-07, 1393/08/16
Expected recruitment end date
2015-01-20, 1393/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Airway Pressure Release Ventilation on patient' hemodynamic after Coronary Artery Bypass Graft
Public title
Effect of mechanical ventilation on hemodynamic
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: age between 40-70 years old; hemodynamic stability in the first visit; EF ≥ 40% ; RASS = -2 to -3; surgery OFF PUMP; CABG without repair or replace the valve; failure to perform CPR during surgery or before the study; failure to perform emergency surgery (out of routine preoperative); absence of underlying lung disease; lack of oxygenation and ventilation disorder; having hypertension before surgery.
Exclusion criteria: CPR performed during study; the need to replace volume; -2< RASS <-3; bleeding more than 100ml / hr of Drains; need to have surgery again; pH arterial <7.25; dysrhythmia that lead to the development of hemodynamic changes.
Age
From 40 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
32
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mashhad University of Medical Sciences
Street address
Daneshgah Street. Qureshi building
City
Mashhad
Postal code
Approval date
2014-10-04, 1393/07/12
Ethics committee reference number
930444
Health conditions studied
1
Description of health condition studied
Coronary artery disease
ICD-10 code
I25.1
ICD-10 code description
Atherosclerotic heart disease
Primary outcomes
1
Description
cardiac index
Timepoint
before intervention, half an hour after intervention & half an hour after return to base mode
Method of measurement
lit/min/BSA
2
Description
stroke volume index
Timepoint
before intervention, half an hour after intervention & half an hour after return to base mode
Method of measurement
mi/BSA
3
Description
mean arterial pressure
Timepoint
before intervention, half an hour after intervention & half an hour after return to base mode
Method of measurement
mmHg
4
Description
systemic vascular resistance
Timepoint
before intervention, half an hour after intervention & half an hour after return to base mode
Method of measurement
Dynes/sec/cm5
Secondary outcomes
1
Description
arterial oxygen saturation
Timepoint
before intervention, half an hour after intervention & half an hour after return to basic mode
Method of measurement
percent
2
Description
ratio ofl arterial oxygen to inspired oxygen fraction
Timepoint
before intervention, half an hour after intervention & half an hour after return to basic mode
Method of measurement
number
3
Description
pressure of arterial co2
Timepoint
before intervention, half an hour after intervention & half an hour after return to basic mode
Method of measurement
mmHg
4
Description
pressure of arterial oxygen
Timepoint
before intervention, half an hour after intervention & half an hour after return to basic mode
Method of measurement
mmHg
Intervention groups
1
Description
Intervention of this research is a ventilation mode is called Airway Pressure Release Ventilation that applied through ventilator and tracheal tube for half an hour. this mode is a inverse ratio mode that patient airway pressure between high pressure and low pressure is fluctuated.in this intervention, the duration of high pressure is 4.5 sec and duration of low pressure is 0.5 sec.The high-level pressure based on the patient's tidal volume required is determined.
Category
Other
2
Description
This study is a cross-over study and no control group. Intervention (APRV mode) compared with SIMV mode. synchronized intermittent mandatory ventilation is a usual mode of mechanical ventilation in research environment.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza hospital- Open heart ICU
Full name of responsible person
Street address
West Ebn-e-Sina Street
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciencse- research assisstance
Full name of responsible person
Dr. Mohsen Tafaghodi
Street address
Daneshgah Street. Before Golestan intersection
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciencse- research assisstance
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
Javad Malekzadeh
Position
Bachelor' degree of nursing education- faculty
Other areas of specialty/work
Street address
Mashhad Nursing & Midwifery School-West Ebn-e-Sina Street
City
Mashhad
Postal code
Phone
+98 51 3859 5511
Fax
Email
malekzadehj@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
Shahram Amini
Position
Associate Professor and Fellowship of Intencive Care Medicine
Other areas of specialty/work
Street address
West Ebn-e-Sina Street. Emem Reza hospital
City
Mashhad
Postal code
Phone
+98 51 3802 2322
Fax
+98 51 3802 2322
Email
aminish@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
Samaneh Zakeri
Position
Student
Other areas of specialty/work
Street address
West Ebn-e-Sina street. Nursing and Midwifery school
City
Mashhad
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)