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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05401526
Other study ID # 2022/629
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 5, 2022
Est. completion date August 5, 2022

Study information

Verified date August 2022
Source Istanbul University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 53
Est. completion date August 5, 2022
Est. primary completion date August 5, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
Turkey Istanbul University Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Istanbul University

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

Ali A, Aygun E, Abdullah T, Bolsoy-Deveci S, Orhan-Sungur M, Canbaz M, Ozkan Akinci I. A challenge with 5 cmH2O of positive end-expiratory pressure predicts fluid responsiveness in neurosurgery patients with protective ventilation: an observational study. Minerva Anestesiol. 2019 Nov;85(11):1184-1192. doi: 10.23736/S0375-9393.19.13721-2. Epub 2019 Jun 17. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Verification of stroke volume index percentage change after SLPC Stroke volume index percentage change after SLPC means " [(SVIT2 - SVIT1) / SVIT1] x 100". Up to 30 minutes
Primary Verification of stroke volume index percentage change after fluid loading 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
Primary Ability of fluid responsiveness prediction with SVV, PPV, and Stroke volume index percentage change after SLPC Predictive ability of SVI changes after SLPC and fluid loading will be compared by statistical analysis (ROC curve) Up to 30 minutes
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