Determining and comparing the effect of Adaptive Support Ventilation and Synchronized Intermittent Mandatory Ventilation on respiratory support outcomes after Coronary Artery Bypass Graft surgery, Isfahan University of Medical sciences, Chamran hospital, 2014
Aim: Comparing the effect(s) of using adaptive support ventilation and synchronized intermittent mandatory ventilation on respiratory support outcomes (ventilation duration, length of hospital stay, unsuccessful weaning cases, and haemodynamic parameters of mean atrial blood pressure (MAP) and SPO2 ) after coronary artery bypass graft surgery.
Design: Randomized, one period, single blinded, two groups
Population: Patients after coronary artery bypass graft surgery which were transferred to cardiac surgery ICU
Main inclusion criteria: The range of age was between 25 and 65 years old; Patients did not have a history of lung diseases (Asthma, ...) or lung and heart surgeries; stable haemodynamic; Ejection fraction was more than 30 percent; Patients did not have renal failure (serum creatinine more than 2), liver disease, and history of seizure and CVA.
Main exclusion criteria: Occurring unstable haemodynamic ststus during research; life threatening cardiac arrhythmia; Unusual hemorrhage after operation; Need to anesthesia and operation again.
Sample size: 64 patients
Intervention: The effect of adaptive support ventilation or synchronized mandatory intermittent ventilation on respiratory support outcomes
Time of intervention: After coronary artery bypass graft surgery
Outcomes: change of respiratory support outcome
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014101919584N1
Registration date:2014-12-30, 1393/10/09
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-12-30, 1393/10/09
Registrant information
Name
Hadi Zarei
Name of organization / entity
Isfahan University of Medical Sciences, faculty of Nursing and Midwifery
Country
Iran (Islamic Republic of)
Phone
+98 31 3442 6105
Email address
hadi.zarei767@gmail.com
Recruitment status
Recruitment complete
Funding source
vice chancellor for research, Isfahan university of medical sciences, Isfahan
Expected recruitment start date
2014-04-21, 1393/02/01
Expected recruitment end date
2014-06-15, 1393/03/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Determining and comparing the effect of Adaptive Support Ventilation and Synchronized Intermittent Mandatory Ventilation on respiratory support outcomes after Coronary Artery Bypass Graft surgery, Isfahan University of Medical sciences, Chamran hospital, 2014
Public title
Using different modes of ventilation after coronary artery bypass graft surgery
Purpose
Supportive
Inclusion/Exclusion criteria
Main inclusion criteria: Using one of the ventilation modes (Adaptive support ventilation (ASV) or synchronized intermittent mandatory ventilation (SIMV)) on Raphael ventilator was allowed by anesthesiologist; The range of age was between 25 and 65 years; Patients did not have a history of lung diseases (Asthma, ...) or lung and heart surgeries; Patients did not have renal failure (serum creatinine more than 2), liver disease, and history of seizure and CVA; left ventricular ejection fraction was more than 30 percent; In the time of ICU entrance patients were haemodynamically stable ( respiratory rate less than 35 per minute, heart rate less than 150 per minute, mean atrial pressure less than 70 mmHg) and intra aortic balloon pump was not used.
Main exclusion criteria: occurring unstable haemodynamic status during research (respiratory rate more than 35 per minute, heart rate more than 150 per minute, mean atrial pressure more than 70 mmHg); life threatening arrhythmia durin research like ventricular tachycardia; need to excess dosages of inotropes and vasoconstrictors during research (Dopamin more than 20 milligram per hour, norepinephrin more than 0.5 milligram per hour, dobotamin more than 25 milligram per hour, and epinephrin with any doses); Unusual bleeding after operation (chest tube drainage more than 500 ml per hour, more than 350 ml per hour for 2 hours, or more than 1000 ml at all) ; Need to anesthesia and operation again.
Age
From 25 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Moral committee of Isfahan university of medical sciences
Street address
Isfahan university of medical sciences, Azadi squre, Hezar Jarib street, Isfahan
City
Isfahan
Postal code
8174673461
Approval date
2014-05-08, 1393/02/18
Ethics committee reference number
717/4/د
Health conditions studied
1
Description of health condition studied
Atherosclerotic heart disease
ICD-10 code
IX125.1
ICD-10 code description
Atherosclerotic heart disease
Primary outcomes
1
Description
Intubation duration
Timepoint
When the intervention starts
Method of measurement
Hour and minutes
2
Description
Length of hospital stay
Timepoint
When the patient is being discharged
Method of measurement
Hour and minutes
Secondary outcomes
1
Description
nothing
Timepoint
nothing
Method of measurement
nothing
Intervention groups
1
Description
Description: In this study, patients after undergoing Coronary Artery Bypass Graft surgery (CABG) and transferring to the intensive care unit (ICU) while intubated, with approval of an anesthesiologist for posibility of using one of the Adaptive Support Ventilation (ASV) or Synchronized Intermittent Mandatory Ventilation (SIMV) modes, were randomized to the intervention or control group.
Intervention group: using Adaptive Support Ventilation mode for respiratory ventilation after coronary artery bypass graft surgery in intensive care unit
Category
Treatment - Other
2
Description
Control group: Using Synchronized Intermittent Mandatory Ventilation mode for respiratory ventilation after coronary artery bypass graft surgery in intensive care unit
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfahan heart diseases center
Full name of responsible person
Hadi Zarei - MS student of critical care nursing
Street address
Chamran hospital, Moshtagh 3 street, Isfahan
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Isfahan university of medical sciences
Full name of responsible person
Dr. Peyman Adibi
Street address
Isfahan university of medical sciences, Hezar jarib street, Azadi square, Isfahan
City
Isfahan
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, 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, faculty of nursing and midwifery
Full name of responsible person
Hadi Zarei
Position
Ms student of critical care nursing (Nurse)
Other areas of specialty/work
Street address
Isfahan university of medical sciences, faculty of nursing and midwifery, Hezar Jarib street, Azadi square, Isfahan
City
Isfahan
Postal code
8174673461
Phone
+98 31 3792 2901
Fax
Email
hadi.zarei767@gmail.com
Web page address
nm.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan university of medical sciences, faculty of nursing and midwifery
Full name of responsible person
Hadi Zarei
Position
Ms student of critical care nursing (nurse)
Other areas of specialty/work
Street address
Faculty of nursing and midwifery, Isfahan university of medical sciences, Hezar Jarib street, Isfahan
City
Isfahan
Postal code
8174673461
Phone
+98 31 3791 2901
Fax
Email
hadi.zarei767@gmail.com
Web page address
nm.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Isfahan university of medical sciences, faculty of nursing and midwifery
Full name of responsible person
Hadi Harei
Position
Ms student of critical care nursing, (nurse)
Other areas of specialty/work
Street address
Faculty of nursing and midwifery, Isfahan university of medical sciences, Hezar Jarib street, Isfahan
City
Isfahan
Postal code
8174673461
Phone
+98 31 3792 2901
Fax
Email
hadi.zarei767@gmail.cim
Web page address
nm.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)