Pleth Variability Index in Modified Prone Position or Knee-chest Position (Concord Position)
Pleth Variability Index as Predictors of Fluid Responsiveness in Modified Prone Position(Concord Position) or Knee-chest Position
1 other identifier
observational
44
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Dec 2019
Shorter than P25 for all trials
1 active site
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
CompletedFirst Posted
Study publicly available on registry
June 28, 2019
CompletedStudy Start
First participant enrolled
December 6, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 26, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2020
CompletedMarch 24, 2022
March 1, 2022
11 months
May 24, 2019
March 23, 2022
Conditions
Keywords
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
Eligibility Criteria
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
MeSH Terms
Interventions
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