Fluid Responsiveness in Prone Position

NCT ID: NCT05401526

Last Updated: 2022-08-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

53 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-06-05

Study Completion Date

2022-08-05

Brief Summary

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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.

Detailed Description

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Conditions

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Anesthesia Spine Fusion

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istanbul University

OTHER

Sponsor Role lead

Responsible Party

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Emre Sertaç Bingül

Medical Doctor, Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Istanbul University

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 31213047 (View on PubMed)

Other Identifiers

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2022/629

Identifier Type: -

Identifier Source: org_study_id

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