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Clinical Trials/NCT03030963
NCT03030963CompletedNot Applicable

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

Gangnam Severance Hospital2 sites in 1 country36 target enrollmentStarted: March 6, 2017Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
36
Locations
2
Primary Endpoint
The amount of intraoperative surgical bleeding

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Triple (Participant, Care Provider, Outcomes Assessor)

Eligibility Criteria

Ages
20 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

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

Exclusion Criteria

  • 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

Arms & Interventions

Equal-ratio ventilation(ERV) group

Experimental

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

Intervention: Equal ratio ventilation(ERV) (Other)

Control group

Active Comparator

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

Intervention: I:E Ratio "1:2 (Other)

Outcomes

Primary Outcomes

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ji-young Kim

Associate Professor

Gangnam Severance Hospital

Study Sites (2)

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