NCT04002193

Brief Summary

To investigate whether PVI predicts the fluid responsiveness in modified prone position undergoing posterior approach cervical operation. Furthermore, modified prone position could influence on dynamic variables including stroke volume variation(SVV), pulse pressure variation(PPV) and PVI.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2019

Shorter than P25 for all trials

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

May 24, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 28, 2019

Completed
5 months until next milestone

Study Start

First participant enrolled

December 6, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 26, 2020

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2020

Completed
Last Updated

March 24, 2022

Status Verified

March 1, 2022

Enrollment Period

11 months

First QC Date

May 24, 2019

Last Update Submit

March 23, 2022

Conditions

Keywords

Pleth variability index

Outcome Measures

Primary Outcomes (1)

  • To assess influence of the position change on PVI and other variables(PPV, SVV)

    When position change from supine to modified prone position, to assess the change of PVI and other variables. The correlation of PVI and cardiac output during this change.

    1.supine position : 5 minute after anesthesia induction with arterial-line insertion 2. 5 min after crystalloid 4 ml/kg loading / 3. modified prone position (baseline)

Secondary Outcomes (1)

  • To measure dynamic variables (pulse pressure variation, stroke volume variation and pleth variability index) in modified prone position

    1. Supine position : 5 minute after anesthesia induction with arterial-line insertion 2. 5 minute after a position change to prone 3. before and after fluid loading

Interventions

To assess fluid responsiveness

Also known as: If stroke volume of FloTrac® decrease 15 % of baseline, crystalloid loading of 4ml/kg will start.

Eligibility Criteria

Age19 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients received cervical operation at modified prone position (concord position)

You may qualify if:

  • American Society of Anaesthesiologists'(ASA) physical status 1-3
  • patients who received cervical operation in modified prone position or knee-chest position

You may not qualify if:

  • Valvular heart disease
  • Congestive heart failure, reduced left ventricular function ( Ejection fraction \< 40%)
  • Moderate grade of pulmonary disease
  • Arrhythmia (atrial fibrillation, atrial flutter.. etc.)
  • body mass index \> 30 or \< 15 kg/m2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, Songpa-gu, South Korea

Location

MeSH Terms

Interventions

BaseLine dental cement

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical instructor of Anesthesiology and Pain department

Study Record Dates

First Submitted

May 24, 2019

First Posted

June 28, 2019

Study Start

December 6, 2019

Primary Completion

October 26, 2020

Study Completion

October 31, 2020

Last Updated

March 24, 2022

Record last verified: 2022-03

Locations