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Effect of Equal Ratio Ventilation on Blood Loss During Posterior Lumbar Interbody Fusion Surgery

Primary Purpose

Blood Loss, Surgical

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Equal ratio ventilation(ERV)
I:E Ratio "1:2
Sponsored by
Gangnam Severance Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Blood Loss, Surgical focused on measuring Equal ratio ventilation(ERV), Peak inspiratory pressure(PIP), Blood loss, Posterior lumbar interbody fusion(PLIF), Prone position

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 1) Age : 20~75 yr-old 2) Surgery : Posterior lumbar interbody fusion(PLIF) 2~3 levels

Exclusion Criteria:

  • 1) Urgent or Emergency case 2) Previous lnstrumentation of lumbar spine (Exclusion : Discectomy, Partial hemilaminiectomy, etc) 3) Concurrent other operation 4) Patients who cannot understand informed consent (ex. Illiterate, Foreigner) 5) Obesity (BIM>30kg/m2) 6) Recent myocardial infarction (within 3 months) 7) Reduced left and right ventricular function (Ejection fraction<40%) or Congestive heart failure 8) Preoperative dysrhythmia 9) Aspirin or Plavix during perioperative periods 10) Lung disease 11) Chronic kidney disease or Dialysis 12) Severe hepatic disease

Sites / Locations

  • Gangnam Severance Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Equal-ratio ventilation(ERV) group

Control group

Arm Description

ventilator inspiration to expiration ratio will be set 1:1.

ventilator inspiration to expiration ratio will be set 1:2.

Outcomes

Primary Outcome Measures

The amount of intraoperative surgical bleeding
The surgical blood loss was compared in the two groups (ERV vs. conrol) during posterior lumbar interbody fusion(PLIF) in prone position.

Secondary Outcome Measures

Full Information

First Posted
January 22, 2017
Last Updated
August 3, 2018
Sponsor
Gangnam Severance Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03030963
Brief Title
Effect of Equal Ratio Ventilation on Blood Loss During Posterior Lumbar Interbody Fusion Surgery
Official Title
Effect of Equal Ratio Ventilation on Blood Loss During Posterior Lumbar Interbody Fusion Surgery: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
March 6, 2017 (Actual)
Primary Completion Date
March 4, 2018 (Actual)
Study Completion Date
March 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gangnam Severance Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Ventilator mode change was associated with decrease in blood loss during posterior lumbar interbody fusion (PLIF) due to decrease in the peak inspiratory pressure (PIP). The purpose of this study was to determine the effect of equal ratio ventilation (ERV), which sets the I:E ratio of the ventilator to 1:1 during volume controlled ventilaiton, on surgical blood loss during PLIF. Investigators hypothesized that ERV would decrease surgical blood loss due to decrease in the PIP.
Detailed Description
After anesthesia, patients will receive ventilator settings according to theri group. The CVP will be measured before and after the prone position to ensure the proper positioning. Airway pressures including peak inspiratory pressure, mean/plateau airway pressure, arterial blood gas analysis data, hct, lactate, body temperature, mean arterial pressure, cardiac index. Recodings will be done 5min afte the induction, 5 min after the prone positioning, sikin suture, and 5min after supine position. Amount of bleeding, coagulation profile and Hct will be recorded 72 hrs after the surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blood Loss, Surgical
Keywords
Equal ratio ventilation(ERV), Peak inspiratory pressure(PIP), Blood loss, Posterior lumbar interbody fusion(PLIF), Prone position

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Equal-ratio ventilation(ERV) group
Arm Type
Experimental
Arm Description
ventilator inspiration to expiration ratio will be set 1:1.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
ventilator inspiration to expiration ratio will be set 1:2.
Intervention Type
Other
Intervention Name(s)
Equal ratio ventilation(ERV)
Other Intervention Name(s)
I:E ratio 1:1
Intervention Description
Set the inspiratory to expiratory ratio 1:1 during mechanical ventilation
Intervention Type
Other
Intervention Name(s)
I:E Ratio "1:2
Intervention Description
Set the inspiratory to expiratory ratio 1:2 during mechanical ventilation
Primary Outcome Measure Information:
Title
The amount of intraoperative surgical bleeding
Description
The surgical blood loss was compared in the two groups (ERV vs. conrol) during posterior lumbar interbody fusion(PLIF) in prone position.
Time Frame
At the end of the surgery, approximately 4 hrs.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 1) Age : 20~75 yr-old 2) Surgery : Posterior lumbar interbody fusion(PLIF) 2~3 levels Exclusion Criteria: 1) Urgent or Emergency case 2) Previous lnstrumentation of lumbar spine (Exclusion : Discectomy, Partial hemilaminiectomy, etc) 3) Concurrent other operation 4) Patients who cannot understand informed consent (ex. Illiterate, Foreigner) 5) Obesity (BIM>30kg/m2) 6) Recent myocardial infarction (within 3 months) 7) Reduced left and right ventricular function (Ejection fraction<40%) or Congestive heart failure 8) Preoperative dysrhythmia 9) Aspirin or Plavix during perioperative periods 10) Lung disease 11) Chronic kidney disease or Dialysis 12) Severe hepatic disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jiyoung Kim
Organizational Affiliation
Gangnam Severance Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gangnam Severance Hospital
City
Seoul
ZIP/Postal Code
06273
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect of Equal Ratio Ventilation on Blood Loss During Posterior Lumbar Interbody Fusion Surgery

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