NCT03030963

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 22, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 25, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

March 6, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 4, 2018

Completed
27 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2018

Completed
Last Updated

August 6, 2018

Status Verified

August 1, 2018

Enrollment Period

12 months

First QC Date

January 22, 2017

Last Update Submit

August 3, 2018

Conditions

Blood Loss, Surgical

Keywords

Equal ratio ventilation(ERV)Peak inspiratory pressure(PIP)Blood lossPosterior lumbar interbody fusion(PLIF)Prone position

Outcome Measures

Primary Outcomes (1)

  • 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.

Study Arms (2)

Equal-ratio ventilation(ERV) group

EXPERIMENTAL

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

Other: Equal ratio ventilation(ERV)

Control group

ACTIVE COMPARATOR

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

Other: I:E Ratio "1:2

Interventions

Equal ratio ventilation(ERV)OTHER

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

Also known as: I:E ratio 1:1
Equal-ratio ventilation(ERV) group
I:E Ratio "1:2OTHER

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

Control group

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gangnam Severance Hospital

Seoul, 06273, South Korea

Location

MeSH Terms

Conditions

Blood Loss, SurgicalHemorrhage

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsIntraoperative Complications

Study Officials

  • Jiyoung Kim

    Gangnam Severance Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 22, 2017

First Posted

January 25, 2017

Study Start

March 6, 2017

Primary Completion

March 4, 2018

Study Completion

March 31, 2018

Last Updated

August 6, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)