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

NCT ID: NCT03030963

Last Updated: 2018-08-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-06

Study Completion Date

2018-03-31

Brief Summary

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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

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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.

Conditions

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Blood Loss, Surgical

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Equal-ratio ventilation(ERV) group

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

Group Type EXPERIMENTAL

Equal ratio ventilation(ERV)

Intervention Type OTHER

Set the inspiratory to expiratory ratio 1:1 during mechanical ventilation

Control group

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

Group Type ACTIVE_COMPARATOR

I:E Ratio "1:2

Intervention Type OTHER

Set the inspiratory to expiratory ratio 1:2 during mechanical ventilation

Interventions

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Equal ratio ventilation(ERV)

Set the inspiratory to expiratory ratio 1:1 during mechanical ventilation

Intervention Type OTHER

I:E Ratio "1:2

Set the inspiratory to expiratory ratio 1:2 during mechanical ventilation

Intervention Type OTHER

Other Intervention Names

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I:E ratio 1:1

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Gangnam Severance Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ji-young Kim

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jiyoung Kim

Role: PRINCIPAL_INVESTIGATOR

Gangnam Severance Hospital

Locations

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Gangnam Severance Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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3-2016-0241

Identifier Type: -

Identifier Source: org_study_id

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