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

Overview

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.

Full Title of Study: “Effect of Equal Ratio Ventilation on Blood Loss During Posterior Lumbar Interbody Fusion Surgery: A Randomized Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Triple (Participant, Care Provider, Outcomes Assessor)
  • Study Primary Completion Date: March 4, 2018

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.

Interventions

  • Other: Equal ratio ventilation(ERV)
    • Set the inspiratory to expiratory ratio 1:1 during mechanical ventilation
  • Other: I:E Ratio “1:2
    • Set the inspiratory to expiratory ratio 1:2 during mechanical ventilation

Arms, Groups and Cohorts

  • Experimental: Equal-ratio ventilation(ERV) group
    • ventilator inspiration to expiration ratio will be set 1:1.
  • Active Comparator: Control group
    • ventilator inspiration to expiration ratio will be set 1:2.

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Gangnam Severance Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Ji-young Kim, Associate Professor – Gangnam Severance Hospital
  • Overall Official(s)
    • Jiyoung Kim, Principal Investigator, Gangnam Severance Hospital

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