Effect of Two Different Fluid Treatment Regimens on Ultrasonographic Upper Airway Measurements
NCT07477392 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 145
Last updated 2026-03-17
Summary
The goal of this randomized controlled double blinded study is to compare the effect of the type of fluid theraphy on ultrasonographic upper airway measurements for spinal surgery in prone position longer than two hours. The main question it aims to answer is how do goal directed fluid theraphy and standard fluid theraphy effect ultrasonographic upper airway measurements.
Participants will be American Society of Anesthesiology (ASA) physical status I and II, between 18- 65 ages.
Resarchers will compare goal-directed fluid therapy with standard fluid theraphy to see if upper airway ultrasonography measurements differs between the groups.
Conditions
- Goal-directed Fluid Theraphy
- Upper Airway Ultrasonography
Interventions
- OTHER
-
Standard fluid theraphy
In this group (group 1), fluid will be administered according to the standard fluid calculation (4-2-1 rule), taking into account the patient's fasting time, evaporation loss, maintenance fluid requirement, replacement of urine output, and surgical loss. Further fluid administration will be adjusted according to hemodynamic parameters to keep heart rate (HR) and mean arterial pressure (MAP) within 20% of baseline.
- OTHER
-
Goal-directed fluid theraphy
In this group (group 2), close PPV (pulse pressure variation) will be followed by intraoperative invasive arterial monitoring and fluid therapy will be given to keep the PPV target below 13%. Fluids or vasopressors will be administered to maintain PPV\<13% and MAP\>65 mmHg targets. If PPV\>13%, 250 mL of balanced crystalloid will be given in 5 minutes and PPV will be re-evaluated after 5 minutes. If MAP\<65 mmHg and PPV\<13, intravenous vasopressor (norepinephrine) therapy will be initiated. A hemoglobin value below 8 mg/dL will be considered as a transfusion trigger for both groups, and total intraoperative intake and output fluids, including blood loss, will be recorded.
Sponsors & Collaborators
-
Bozyaka Training and Research Hospital
lead OTHER
Principal Investigators
-
Nazlı N Deniz, MD · Izmir Bozyaka Training and Research Hospital
-
Hande H Şahinkaya, MD · Izmir Bozyaka Training and Research Hospital
-
Zeki T Tekgül, Prof. · Izmir Bozyaka Training and Research Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-03-01
- Primary Completion
- 2023-09-01
- Completion
- 2025-10-01
Countries
- Turkey (Türkiye)
Study Locations
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