Fluid Responsiveness in Prone Position

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.

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Key information

Conditions

Anesthesia Spine Fusion

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Istanbul University

Istanbul, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

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".
Verification of stroke volume index percentage change after fluid loading

Time frame: Up to 30 minutes

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.
Ability of fluid responsiveness prediction with SVV, PPV, and Stroke volume index percentage change after SLPC

Time frame: Up to 30 minutes

Predictive ability of SVI changes after SLPC and fluid loading will be compared by statistical analysis (ROC curve)

Sponsors and collaborators

Lead sponsor

Istanbul University

Other

Registry information

Official study title

Ability of Challenge With 5 cmH2O of Positive End-expiratory Pressure to Predict Fluid Responsiveness in Prone Position: An Observational Study

Important dates

Study start: 2022
Primary completion: 2022
Study completion: 2022
First posted: Jun 2, 2022
Registry last updated: Aug 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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