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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03030963
Recruitment Status : Completed
First Posted : January 25, 2017
Last Update Posted : August 6, 2018
Sponsor:
Information provided by (Responsible Party):
Ji-young Kim, Gangnam Severance Hospital

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.

Condition or disease Intervention/treatment Phase
Blood Loss, Surgical Other: Equal ratio ventilation(ERV) Other: I:E Ratio "1:2 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Equal Ratio Ventilation on Blood Loss During Posterior Lumbar Interbody Fusion Surgery: A Randomized Controlled Trial
Actual Study Start Date : March 6, 2017
Actual Primary Completion Date : March 4, 2018
Actual Study Completion Date : March 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arm Intervention/treatment
Experimental: Equal-ratio ventilation(ERV) group
ventilator inspiration to expiration ratio will be set 1:1.
Other: Equal ratio ventilation(ERV)
Set the inspiratory to expiratory ratio 1:1 during mechanical ventilation
Other Name: I:E ratio 1:1

Active Comparator: Control group
ventilator inspiration to expiration ratio will be set 1:2.
Other: I:E Ratio "1:2
Set the inspiratory to expiratory ratio 1:2 during mechanical ventilation




Primary Outcome Measures :
  1. The amount of intraoperative surgical bleeding [ Time Frame: At the end of the surgery, approximately 4 hrs. ]
    The surgical blood loss was compared in the two groups (ERV vs. conrol) during posterior lumbar interbody fusion(PLIF) in prone position.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03030963


Locations
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Korea, Republic of
Gangnam Severance Hospital
Seoul, Korea, Republic of, 06273
Sponsors and Collaborators
Gangnam Severance Hospital
Investigators
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Principal Investigator: Jiyoung Kim Gangnam Severance Hospital
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Responsible Party: Ji-young Kim, Associate Professor, Gangnam Severance Hospital
ClinicalTrials.gov Identifier: NCT03030963    
Other Study ID Numbers: 3-2016-0241
First Posted: January 25, 2017    Key Record Dates
Last Update Posted: August 6, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ji-young Kim, Gangnam Severance Hospital:
Equal ratio ventilation(ERV)
Peak inspiratory pressure(PIP)
Blood loss
Posterior lumbar interbody fusion(PLIF)
Prone position
Additional relevant MeSH terms:
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Hemorrhage
Blood Loss, Surgical
Pathologic Processes
Intraoperative Complications