Protocol summary

Summary
Aims: The key purpose of this study is to determine the impact of two approaches "volumetric and pressure ventilation" on intra operative blood loss and posterior spine fixation. Design: In This clinical trial, 78 patients in two groups of 39 people are studied. Conduct: With no prior knowledge, one group started to use 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 mmHg. The other group receives pressure ventilation with initial pressure 15 H2O/cm and 12 cycles per minute inspiration rate and inhale to exhale ratio 1:2 without peep. Then the current volume is adjusted to 7ml/kg/IBW by changing the pressure to achieve the end exhale carbon dioxide 35-40 mmHg by changing the inspiration rate. Participations: Among patients aged 18-75 in class1, 2 ASA, nominated for posterior spine fixation operation surgery were justified for the study and written consent derived from them. In this study patients with cardiopulmonary diseases history, uncontrolled hypertension or diabetes, SCI, coagulopathies, or treated by aspirin, heparin, and warfarin, and BMI more than 35 are omitted. Interventions: Blood pressure and heart beat of the studied patients are checked every 15 minutes after anesthesia. Then satisfaction of surgeon asked. Main outcome: Duration and intensity of bleeding are compared until the end of operations between the two groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016122731611N1
Registration date: 2017-03-18, 1395/12/28
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-03-18, 1395/12/28
Registrant information
Name
Manoochehr Salimian
Name of organization / entity
Kashan Univercity of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 5531 6824
Email address
salimian-m@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kashan University of Medical Sciences
Expected recruitment start date
2016-10-01, 1395/07/10
Expected recruitment end date
2017-10-22, 1396/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of two ventilation methods "volume control & pressure control" on blood loss of posterior Spinal fixation surgery
Public title
Comparison of two ventilation methods "volume control & pressure control" on blood loss of posterior Spinal fixation surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients aged 18-75 with physical condition scored 1 or 2 from American Anesthesia Association nominated for elective-fusion posterior spine surgery operation in 3-4 levels, hospitalized for traumatic fracture of the lumbar spine. Exclusion criteria: Patients with cardiopulmonary disorders; uncontrolled hypertension and diabetes; SCI and coagulopathies patients and patients with BMI more than 35; or treated by aspirin; heparin and warfarin are excluded from the study.
Age
From 18 years old to 75 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 78
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
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, 5th Km, Kashan Road, 8715988141, Kashan, I. R. Iran
City
Kashan
Postal code
8715988141
Approval date
2016-09-28, 1395/07/07
Ethics committee reference number
IR.KAUMS.REC.1395.50

Health conditions studied

1

Description of health condition studied
Fracture of lumbar vertebra
ICD-10 code
S32.0
ICD-10 code description
Fracture of lumbar vertebra

Primary outcomes

1

Description
surgical blood loss
Timepoint
End of surgery
Method of measurement
Calculating the amount of blood in the suction drain and bleed by ml accumulat

Secondary outcomes

1

Description
Hypotension
Timepoint
During operation
Method of measurement
Continuous NIBP monitoring

2

Description
surgeon's satisfaction of 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

Intervention groups

1

Description
First group: during the surgery operation, volumetric ventilation was started 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 mmHg.
Category
Treatment - Other

2

Description
Second group: during the surgery operation, 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 mmHg by changing the inspiration rate.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Beheshti Hospital
Full name of responsible person
Dr. Manoochehr Salimian
Street address
Shahid Beheshti Hospital , Ghotb-e-Ravandi Blvd, 5th Km, Kashan Road, 8715988141, Kashan, I. R. Iran
City
Kashan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research and Technology Kashan University of Medical Sciences
Full name of responsible person
GolamAli Hmidi MD.
Street address
Kashan University of Medical Sciences, Ghotb-e-Ravandi Blvd, 5th Km, Kashan Road, 8715988141, Kashan, I. R. Iran
City
Kashan
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 and Technology Kashan 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
Kashan University of Medical Sciences
Full name of responsible person
Manoochehr Salimian
Position
Anesthesia resident
Other areas of specialty/work
Street address
Shahid Beheshti Hospital , Ghotb-e-Ravandi Blvd, 5th Km, Kashan Road, 8715988141, Kashan, I. R. Iran
City
Kashan
Postal code
8715988141
Phone
+98 31 5554 0025
Fax
Email
Drmsr_44@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Mohammad Haji Jafari
Position
Anesthesiologist and pain
Other areas of specialty/work
Street address
Shahid Beheshti Hospital , Ghotb-e-Ravandi Blvd, 5th Km, Kashan Road, 8715988141, Kashan, I. R. Iran
City
Kashan
Postal code
8715988141
Phone
+98 31 5554 0025
Fax
Email
Dr_hajijafari@kaums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Manoochehr
Position
Anesthesiology residents
Other areas of specialty/work
Street address
Kashan University of Medical Sciences, Ghotb-e-Ravandi Blvd, 5th Km, Kashan Road, 8715988141, Kashan, I. R. Iran
City
Kashan
Postal code
8715988141
Phone
+98 31 5554 2999
Fax
+98 31 5557 5057
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
Loading...