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

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07477392 on ClinicalTrials.gov