In this study, we attempt to compare effects of lung protective ventilation with the current standard method on the incidence of pulmonary complications after surgery in long-term coronary artery bypass grafting surgeries (CABG) (over 120 minutes). The study is a double-blind randomized clinical trial in the Moheb hospital from March 2014 until March 2015. Inclusion criteria are patients candidate for CABG operation under general anesthesia without any specific medical disorder. Exclusion criteria are Hemoglobin < 10; Albumin <3 g/dl; Continuous hemodynamic unstability; Resistant shock; Prediction of long term mechanical ventilation after the surgery; non-early extubation (more than 6 hours after end of the surgery). Patients with inclusion criteria are randomized with quadric block method into two groups of 32 people with specific code, as Conventional ventilation group with tidal volume 9 ml per kg and positive end-expiratory pressure 0 and lung protective ventilation group with tidal volume 6 mL per kg and positive end-expiratory pressure 10. In the intervention group, the recruitment maneuver is performed after induction of anesthesia. Dyspnea, cough, sputum and chest and abdominal pain will be measured according to the VAS scale, also Postoperative pulmonary complications (PPC), as well as modified Clinical Pulmonary Infection Score (mCPIS) before and in the first 24 hours after the operation. IL-6 levels is measured before, exactly after and also after 24 hours of the surgery.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015040115774N3
Registration date:2015-06-25, 1394/04/04
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-06-25, 1394/04/04
Registrant information
Name
Mohammad Mahdi Zamani
Name of organization / entity
Tehran University of Medical Sciences, Students' Scientific Research Center
Country
Iran (Islamic Republic of)
Phone
+98 21 8898 9162
Email address
hin@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Iran University of Medical Sciences
Expected recruitment start date
2014-03-15, 1392/12/24
Expected recruitment end date
2015-03-15, 1393/12/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Intraoperative lung protective ventilation with conventional ventilation on postoperative pulmonary complications in CABG
Public title
Comparison of Intraoperative lung protective ventilation with conventional ventilation on postoperative pulmonary complications in CABG
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria are patients candidate for CABG operation under general anesthesia; Patient's satisfaction with participating in the study and doing the respiratory examinations; BMI< 30 kg/m² age more than 18 and under 70; No pregnancy; No emergent surgery; No previous respiratory system surgery; No history of chronic obstructive pulmonary disease; No sleep disorder; No History of immune suppressant therapy( chemotherapy or radiotherapy) in the last 2 months; No acute respiratory damage or acute respiratory distress syndrome; No repeated treatment with systemic corticosteroid; No liver or neuromuscular disorders; No alcohol or substance abuse; No anesthetic drugs allergy; No cigarette smoking (less than 10 pack/year).
Exclusion criteria are Hemoglobin < 10; Albumin <3 g/dl; Continuous hemodynamic unstability; Resistant shock; Prediction of long term mechanical ventilation after the surgery; non-early extubation (more than 6 hours after end of the surgery).
Age
From 18 years old to 70 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)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Commitee of Iran University of Medical Sciences
Street address
West Hemmat Highway
City
Tehran
Postal code
Approval date
2014-05-12, 1393/02/22
Ethics committee reference number
774/105/د93
Health conditions studied
1
Description of health condition studied
postoperation complications of respiratory system
ICD-10 code
J95.9
ICD-10 code description
Postprocedural respiratory disorder, unspecified
Primary outcomes
1
Description
postoperative pulmonary complications
Timepoint
after the surgery
Method of measurement
3 or more of these six postoperative pulmonary complications: cough, discharge increase, dyspnea, chest pain, temperature more than 38C, heart rate >100 per minute
Secondary outcomes
1
Description
Modified Clinical Pulmonary Infection Score
Timepoint
After the surgery
Method of measurement
According to mentioned parameteres : Glasco scale, Mean Arterial Pressure, need for vasopressor to support cardiovascular system,Serum Aspartate Transaminase Level, Liver bilirubin, Protrombin time and platlets, coagulation factors and serum creatine
2
Description
IL-6 levels
Timepoint
before, exactly after and also after 24 hours of the surgery.
Method of measurement
laboratory
Intervention groups
1
Description
The control group receives common ventilation with tidal volume= 9 ml/kg and respiratory rate adjustment with EtCO2= 30-35 cmH20 and PEEP=0.
Category
Treatment - Devices
2
Description
Intervention group recieves lung protective ventilation with tidal volume=6 ml/kg and respiratory rate adjustment with EtCo2=30-35 cmH2o and PEEP=10 cmH2o. In the intervention group, the recruitment maneuver is performed after induction of anesthesia.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Moheb Hospital
Full name of responsible person
Dr. Mohammad Mahdi Zamani
Street address
Lida st., above vanak field, Valiasr st.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Iran university of medical sciences
Full name of responsible person
Dr.Morteza Naserbakht
Street address
floor 5, central building, junction of Shahid Hemmat & Shahid Chamran Expressways, Tehran
City
Tehran
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, Iran 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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of Anesthesiology and Critical Care, Iran University of Medical Sciences
Full name of responsible person
Dr. Mohammad Reza Ghodrati
Position
Associated Professor/Attending Physician
Other areas of specialty/work
Street address
Department of Anesthesiology, Firoozgar Hospital, Behafarin St.
City
Tehran
Postal code
1593748771
Phone
+98 21 8490 2450
Fax
+98 21 8863 3039
Email
mrghodrati@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)