Fluid Responsiveness in Prone Position
August 5, 2022 updated by: Emre Sertaç Bingül, Istanbul University
Ability of Challenge With 5 cmH2O of Positive End-expiratory Pressure to Predict Fluid Responsiveness in Prone Position: An Observational Study
We are planning to measure hemodynamic parameters (Heart Rate, Mean Arterial Pressure, Stroke Volume Index, Stroke Volume Variation, and Pulse Pressure Variation) and ventilatory parameters at four times (T1, T2,T3, and T4) during spinal operation at prone position.
First measurement (T1, First baseline) will be performed in the prone position after performing tracheal intubation and confirming hemodynamic stability (defined as mean arterial pressure <10% for 3 minutes).
After the T1 measurement, additional 5 cmH2O PEEP (Positive end-expiratory pressure) will be applied for 30 seconds which will be called as "short term low PEEP challenge (SLPC)".
At the end of the SLPC and prior to PEEP lowering, T2 measurement will be performed and recorded.
After the T2 measurement, PEEP will be decreased to the initial value (5 cmH2O) and three minutes later, a second baseline (T3) measurement will be performed.
Thereafter, 500 ml isotonic saline will be loaded in 10 minutes.
T4 measurement will be performed again three minutes after volume loading.
All of the measurements will be completed before surgery start and surgical stimulus.
Patients exhibiting an increase in stroke volume index more than 15% after fluid loading (between T3 and T4) will be classified as volume responders.
Absolute pulse pressure variation change due to SLPC, Absolute Stroke volume variation change due to SLPC, stroke volume index percentage change due to SLPC, and stroke volume index percentage change after fluid loading will be calculated and compared.
Our aim is to observe if short term low PEEP challenge has the ability to predict fluid responsiveness better than pulse pressure variation and stroke volume variation for patients operated in prone position.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
53
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
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Istanbul, Turkey
- Istanbul University
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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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Adult patients undergoing spine surgery in prone position
Description
Inclusion Criteria:
- Patients undergoing spine surgery in prone position
- Age≥ 18 years
- Elective surgery
Exclusion Criteria:
- American Society of Anesthesiology physical status over III
- Valvular heart disease
- Any ventricular dysfunction
- Preoperative arrythmias
- Preoperative hemodynamic instability
- Preoperative uncontrolled hypertension
- Preoperative uncontrolled diabetes mellitus
- History of lung disease
- Morbid obesity (Body mass index ≥ 40 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: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Verification of stroke volume index percentage change after SLPC
Time Frame: Up to 30 minutes
|
Stroke volume index percentage change after SLPC means " [(SVIT2 - SVIT1) / SVIT1] x 100".
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Up to 30 minutes
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Verification of stroke volume index percentage change after fluid loading
Time Frame: Up to 30 minutes
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Stroke volume variation and pulse pressure variation values will be measured at second baseline (T3) and after fluid loading (T4). Fluid responsive patients means " stroke volume index increase after fluid loading ≥ 15%". In another explanation; [(SVIT4- SVIT3)/ SVI (T3)]x100 ≥ 15% means fluid responsive patients. |
Up to 30 minutes
|
|
Ability of fluid responsiveness prediction with SVV, PPV, and Stroke volume index percentage change after SLPC
Time Frame: Up to 30 minutes
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Predictive ability of SVI changes after SLPC and fluid loading will be compared by statistical analysis (ROC curve)
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Up to 30 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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)
June 5, 2022
Primary Completion (Actual)
August 5, 2022
Study Completion (Actual)
August 5, 2022
Study Registration Dates
First Submitted
May 26, 2022
First Submitted That Met QC Criteria
June 1, 2022
First Posted (Actual)
June 2, 2022
Study Record Updates
Last Update Posted (Actual)
August 8, 2022
Last Update Submitted That Met QC Criteria
August 5, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- 2022/629
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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