Effect of Two Different Fluid Treatment Regimens on Ultrasonographic Upper Airway Measurements

March 13, 2026 updated by: Nazlı Saruhan, Bozyaka Training and Research Hospital

Comparison of the Effects of Goal-directed Fluid Theraphy on Airway Ultrasonographic Measurements: Randomized, Controlled, Double-blinded Clinical Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In this prospective, randomized, double-blind study, patients aged between18-65 years, American Society of Anesthesiologists (ASA) physical status classification I and II , scheduled to elective spinal surgery longer than 120 minutes in the prone position. Patients will be informed about the study and written consent will be included in the study after their consent has been obtained. All patients will undergo a detailed preoperative anesthetic evaluation. Patients will be monitored standard non-invasively with electrocardiography, peripheral O2 saturation and non-invasive blood pressure. EEG monitoring (Bispectral index (BIS)) for sleep-wake status will be provided with an electrode placed on the forehead of the patient. Two 20 Gauge intravenous cannulas will be placed in the upper extremities of all patients. All patients will be administered general anesthesia with inhalation anesthesia. Patients will be divided into two groups according to the list to be created using a computer based program (http://www.randomizer.org). Numbering of the cases will be done according to the order of arrival in the operating room. Upper airway ultrasonography will be performed on all patients in the premedication room in the supine position using a bedside ultrasound device (Toshiba Aplio 500) and a linear high-frequency (10-13 mHz) probe. Epiglottic thickness (mm) will be recorded in the patient follow-up form.

The patient will be taken to the operating room after the USG measurements. In both groups, premedication will not be applied to the patients before general anesthesia. After preoxygenation (6 L/min oxygen for 5 minutes via a face mask) in the supine position, anesthesia induction will be done. In both groups, intravenous 2 mg/kg propofol and 1µg/kg remifentanil will be used as hypnotic agents in the induction of general anesthesia. Remifentanil infusion of 0.2 µg/kg/min will be started 2 minutes before induction, based on ideal body weight. Muscle relaxation will be performed with 0.6 mg/kg rocuronium bromide based on total body weight. Muscle relaxation will be maintained by administering 0.15 mg/kg IV rocuronium bromide every 30 minutes intraoperatively. An endotracheal tube with an internal diameter of 7/7.5 mm for women and an internal diameter of 8/8.5 mm for men will be used, and the tracheal tube will be adjusted to maintain the cuff pressure at 20 to 25 cm H2O. General anesthesia will be maintained with a mixture of oxygen (40%) and air, sevoflurane (titrated to keep the BIS value between 40 and 60), remifentanil (0.2 µg/kg/min). Lungs will be ventilated intraoperatively with a tidal volume of 6-8 mL/kg, a PEEP of 8 cm H2O, and a fresh gas flow rate of 2 L/min. Respiration rate will be adjusted so that the end tidal carbon dioxide value is kept between 35-40 mm Hg. In addition to non-invasive monitoring, invasive radial arterial pressure, tympanic temperature and urine output will also be monitored. Normothermia (36-37°C) will be maintained using a heater throughout the intraoperative period. Patients will be randomly divided into two groups.

Group 1 (Standard Fluid Therapy Group):

In Group 1, fluid will be administered according to the standard fluid calculation (4-2-1 rule) considering 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.

Group 2 (Targeted Fluid Therapy Group):

In Group 2, close PPV (pulse pressure variation) monitoring will be performed with 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 mm Hg targets. If PPV>13, 200 mL of stable crystalloid will be administered over 5 minutes and PPV will be reassessed after 5 minutes. If MAP is <65 mmHg and PPV is <13%, vasopressor (norepinephrine) treatment will be started through the intravenous line. A hemoglobin value below 8 mg/dL will be considered as a transfusion trigger for both groups and total intraoperative input and output including blood loss will be recorded.

In both groups, sevoflurane and remifentanil infusion will be stopped while the skin is closed. After the operation the patient will be placed in the supine position again. Reversal of neuromuscular blockade before extubation will be done with sugammadex (2-4 mg/kg). When the patient is awake (BIS value >80), tracheal extubation will be performed. Ultrasonography will be performed using a bedside ultrasound device (Toshiba Aplio 500) and a linear high-frequency (10-13 mHz) probe. Epiglottic thickness (mm) will be recorded in the patient follow-up form. Patients will be followed up and recorded in terms of stridor, need for re-intubation, hoarseness, and cough in the PACU and within 24 hours postoperatively. All data will be statistically analyzed.

Study Type

Interventional

Enrollment (Actual)

145

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Bozyaka
      • Izmir, Bozyaka, Turkey (Türkiye), 35100
        • Izmir Bozyaka Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 18-65 years old
  • ASA (American Association of Anesthesiologists) I and II
  • Elective spine surgery in prone position
  • Surgeries longer than 120 minutes

Exclusion Criteria:

  • Chronic pulmonary disease
  • Renal dysfunction (glomerular filtration rate <30 ml/kg/min)
  • Congestive heart failure (ejection fraction ≤35%)
  • Serious arrhythmias
  • Peripheral vascular disease
  • Pregnance
  • Patients with coagulation disorders
  • Patients who need more than 2 intubation attempts
  • Prior cervical surgery
  • Patients with neck extension limitation
  • Upper respiratory tract infection in the last 3 weeks
  • Patients expected to have a difficult airway (Mallampati III-IV)
  • Patients with a body mass index (BMI) of 35 and above
  • Patient's refusal

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard fluid theraphy
In this group, fluid will be administered according to the standard fluid calculation (4-2-1 rule).
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.
Active Comparator: Goal-directed fluid theraphy
In this group, 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%.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Epiglottic thickness
Time Frame: immediately before surgery
Epiglottic thickness is the measurement of epiglottis by ultrasonography with a lineer probe.
immediately before surgery
Tongue thickness
Time Frame: immediately before surgery
The measurement of tongue will be done by ultrasonography with a lineer probe.
immediately before surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of participants with stridor
Time Frame: Within 24 hours postoperatively
Upper airway problem with the need of oxygen administration due to edema
Within 24 hours postoperatively
number of participants with reintubation
Time Frame: Within 24 hours postoperatively
Endotracheal intubation in the recovery period after general anethesia
Within 24 hours postoperatively
number of participants with cough
Time Frame: Within 24 hours postoperatively
Upper airway problem due to edema
Within 24 hours postoperatively
number of participants with hoarseness
Time Frame: Within 24 hours postoperatively
Upper airway problem due to edema of vocal cords
Within 24 hours postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bozyaka Training and Research Hospital

Investigators

  • Principal Investigator: Nazlı N Deniz, MD, Izmir Bozyaka Training and Research Hospital
  • Study Chair: Hande H Şahinkaya, MD, Izmir Bozyaka Training and Research Hospital
  • Study Chair: Zeki T Tekgül, Prof., Izmir Bozyaka Training and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2023

Primary Completion (Actual)

September 1, 2023

Study Completion (Actual)

October 1, 2025

Study Registration Dates

First Submitted

October 6, 2023

First Submitted That Met QC Criteria

March 13, 2026

First Posted (Actual)

March 17, 2026

Study Record Updates

Last Update Posted (Actual)

March 17, 2026

Last Update Submitted That Met QC Criteria

March 13, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Nazlitez

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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