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

Effect of Equal Ratio Ventilation on Blood Loss During Posterior Lumbar Interbody Fusion Surgery: A Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Blood Loss, Surgical
• Intervention / Treatment: Other: Equal ratio ventilation(ERV); Other: I:E Ratio "1:2

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.

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 06273
    • Gangnam Severance Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At the end of the surgery, approximately 4 hrs.

Collaborators and Investigators

• Sponsor: Gangnam Severance Hospital
• Investigators: Principal Investigator: Jiyoung Kim, Gangnam Severance Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 6, 2017
• Primary Completion (Actual): March 4, 2018
• Study Completion (Actual): March 31, 2018

Study Registration Dates

• First Submitted: January 22, 2017
• First Submitted That Met QC Criteria: January 24, 2017
• First Posted (Estimate): January 25, 2017

Study Record Updates

• Last Update Posted (Actual): August 6, 2018
• Last Update Submitted That Met QC Criteria: August 3, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Prone position; Blood loss; Equal ratio ventilation(ERV); Peak inspiratory pressure(PIP); Posterior lumbar interbody fusion(PLIF)
• Additional Relevant MeSH Terms: Pathologic Processes; Intraoperative Complications; Hemorrhage; Blood Loss, Surgical
• Other Study ID Numbers: 3-2016-0241

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No