Comparison of the effects of volume-controlled with pressure-controlled mechanical ventilation on blood loss in patients undergoing endoscopic sinus surgery
The key purpose of this study is to determine the impact of two mechanical ventilation mode "volume control & pressure control" on blood loss during endoscopic sinus surgery.
Design
Randomized clinical trial, with two parallel groups of 52 (group 1: mechanical ventilation with volume mode, group 2: mechanical ventilation with pressure mode). single blinded: the participants will be blind to the ventilation mode.
Settings and conduct
patients who referred to the operating room in Kashan Matini Hospital for endoscopic sinus surgery will be enrolled. One group will receive volumetric ventilation with current volume 7ml/kg/IBW, 12 cycles per minute inspiration rate and inhale to exhale ratio 1:2 without PEEP, during the operation. The inspiration rate is altered to achieve end exhale carbon dioxide of 30-45 mm Hg. The other group will receive pressure ventilation with initial pressure 15 H2O/cm and 12 cycles per minute, and inhale to exhale ratio 1:2 without PEEP. Then the current volume will be adjusted to 7ml/kg/IBW by changing the pressure to achieve the end exhale carbon dioxide 35-40 mm Hg by changing the inspiration rate. Blood pressure and heart rate of the patients will be checked every 15 minutes after anesthesia.
Participants/Inclusion and exclusion criteria
Patients who aged 15-75, with ASA class1or 2 , nominated for endoscopic sinus surgery, informed about the study, and signed the informed consent from will be included in the study. Patients with chronic hypertension, respiratory problems, repeated surgery, emergency surgery, and coagulopathies, will be excluded.
Intervention groups
First group: mechanical ventilation with volume mode
Second group: mechanical ventilation with pressure mode
Main outcome variables
Intensity and volume of bleeding during the operation will be compared between two groups.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190408043202N1
Registration date:2019-06-25, 1398/04/04
Registration timing:prospective
Last update:2019-06-25, 1398/04/04
Update count:0
Registration date
2019-06-25, 1398/04/04
Registrant information
Name
Seyed amir masoud Farzadfar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5554 0021
Email address
farzadfar-am@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-08-13, 1398/05/22
Expected recruitment end date
2020-03-19, 1398/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of volume-controlled with pressure-controlled mechanical ventilation on blood loss in patients undergoing endoscopic sinus surgery
Public title
Effect of ventilation mode on blood loss during endoscopic sinus surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with ASA class 1& 2
Patients referred to operating room for endoscopic sinus surgery
Exclusion criteria:
Patients with chronic hypertension
Respiratory problems
Repeated surgery
Emergency surgery
Hemorrhagic diseases
Taking anti-coagulant medications
Patients who didn't sign the consent form
Age
From 15 years old to 75 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Sample size
Target sample size:
104
Randomization (investigator's opinion)
Randomized
Randomization description
After obtaining the informed consent, the enrolled patients will be randomly divided into two groups of 52. To achieve a balanced sample size across two groups, a permuted block randomization method will be used. We will make blocks with 4 and 6 samples for better randomization of groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
The enrolled patients, will be blind to the mode of ventilation used during anesthesia.Clinician would be blind for measurement of outcome.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kashan University of Medical Sciences
Street address
Kashan University of Medical Sciences, Ghotb-e-Ravandi Blvd, Kashan, I. R. Iran
City
Kashan
Province
Isfehan
Postal code
8715988141
Approval date
2018-08-13, 1397/05/22
Ethics committee reference number
IR.KAUMS.MEDNT.REC.1397.038
Health conditions studied
1
Description of health condition studied
Blood loss during endoscopic sinus surgery
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Surgical blood loss
Timepoint
End of surgery
Method of measurement
Measuring the amount of blood accumulated in suction instrument and absorbed by dressing gauzes in ml.
Secondary outcomes
1
Description
Hypotension
Timepoint
During the operation
Method of measurement
Continuous NIBP monitoring
2
Description
Surgeon's satisfaction with a bloodless field
Timepoint
At the end of surgery
Method of measurement
Surgeon's satisfaction scoring system
3
Description
Number of infused blood bags
Timepoint
At the end of surgery
Method of measurement
Counting the number of infused blood bags
4
Description
Level of serum hemoglobin
Timepoint
Before starting the surgery and 6 hours after the end of the procedure
Method of measurement
Doing Complete Blood Cell (CBC) test on blood samples using cell counter.
Intervention groups
1
Description
Intervention group 1: during the surgery, this group will receive volumetric ventilation with a current volume of 7 ml/kg/IBW, inspiration rate of 12 cycles per minute and inhale to exhale ratio of 1:2 without PEEP and the inspiration rate is changed to achieve exhale end carbon dioxide of 35-40 mm Hg.
Category
Treatment - Other
2
Description
Intervention group 2: during the surgery, this group will receive pressure ventilation with the initial pressure of 15 H2O/cm, inspiration rate of 12 cycles per minute and inhale to exhale ratio 1:2 with no PEEP drops down. Then the current volume will be achieved to 7 ml/kg/IBW by changing the pressure and the exhale end carbon dioxide will reach to 35-40 mm Hg by changing the inspiration rate.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Matini Hospital
Full name of responsible person
Dr. Seyed amir masoud Farzadfar
Street address
Matini Hospital, Amirkabir Street, Kashan, Iran
City
Kashan
Province
Isfehan
Postal code
871674291
Phone
+98 31 5534 2020
Email
farzadfar-am@kaums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr. Hamid Reza Banafsheh
Street address
Kashan University of Medical Sciences, Ghotb-e-Ravandi Blvd, , Kashan, I. R. Iran
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5554 0021
Email
Drmsr_44@yahoo.com
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
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Seyed amir masoud Farzadfar
Position
Anesthesiology resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Kashan University of Medical Sciences, Ghotb-e-Ravandi Blvd, Kashan, I. R. Iran
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5554 0021
Email
farzadfar-am@kaums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Mohammad Hajijafari
Position
Anesthesiologist
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Kashan University of Medical Sciences, Ghotb-e-Ravandi Blvd, Kashan, I. R. Iran
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5554 0025
Email
Dr_hajijafari@kaums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Seyed amir masoud Farzadfar
Position
Anesthesiology residents
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Kashan University of Medical Sciences, Ghotb-e-Ravandi Blvd, Kashan, I. R. Iran
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5554 0025
Email
farzadfar-am@kaums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available