- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04002193
Pleth Variability Index in Modified Prone Position or Knee-chest Position (Concord Position)
March 23, 2022 updated by: Heesun Park, Asan Medical Center
Pleth Variability Index as Predictors of Fluid Responsiveness in Modified Prone Position(Concord Position) or Knee-chest Position
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Objective :
To compare measurements of pleth variability index (PVI), pulse pressure variation (PPV) and stroke volume variation (SVV) to predict fluid responsiveness in modified prone position or knee-chest position (concord position) for cervical operation.
To identify Influence of the modified prone position (concord position) on these variables.
Method
- To assess influence of the position change on PVI and other variables(PPV, SVV)
- To assess PVI to predict fluid responsiveness at modified prone position
Study Type
Observational
Enrollment (Actual)
44
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Songpa-gu
-
Seoul, Songpa-gu, Korea, Republic of
- Asan Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 79 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Patients received cervical operation at modified prone position (concord position)
Description
Inclusion Criteria:
- American Society of Anaesthesiologists'(ASA) physical status 1-3
- patients who received cervical operation in modified prone position or knee-chest position
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To assess influence of the position change on PVI and other variables(PPV, SVV)
Time Frame: 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)
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To measure dynamic variables (pulse pressure variation, stroke volume variation and pleth variability index) in modified prone position
Time Frame: 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
|
Record the data of variables after 5 minute hemodynamic stability without changes of drugs
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 6, 2019
Primary Completion (Actual)
October 26, 2020
Study Completion (Actual)
October 31, 2020
Study Registration Dates
First Submitted
May 24, 2019
First Submitted That Met QC Criteria
June 27, 2019
First Posted (Actual)
June 28, 2019
Study Record Updates
Last Update Posted (Actual)
March 24, 2022
Last Update Submitted That Met QC Criteria
March 23, 2022
Last Verified
March 1, 2022
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- HePark
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
IPD Plan Description
We did not have the permission of data share from institutional review board.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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