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Goal-directed Fluid TheraphyNCT07477392

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

A study testing Standard fluid theraphy and Goal-directed fluid theraphy in people with Goal-directed Fluid Theraphy and Upper Airway Ultrasonography, run by Bozyaka Training and Research Hospital at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
Standard fluid theraphy and Goal-directed fluid theraphy
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
145 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Mar 2023to 1 Oct 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • Chronic pulmonary disease
  • Renal dysfunction (glomerular filtration rate <30 ml/kg/min)
  • Congestive heart failure (ejection fraction ≤35%)
  • Serious arrhythmias
  • Peripheral vascular disease
  • Pregnance
Show all 14Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Izmir Bozyaka Training and Research Hospital

    Izmir, Bozyaka, 35100

Other trials in Turkey (Türkiye)

About this study

Official title: 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.

Read the 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.

Being tested
Standard fluid theraphy, Goal-directed fluid theraphy
Keywords
epiglottis thickness, tongue root thickness, pulse pressure variation, fluid theraphy, spinal surgery

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Standard fluid theraphyOther

    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.

  • Goal-directed fluid theraphyOther

    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.

Study groups in NCT07477392
Study groupRoleWhat they receive
Standard fluid theraphyActive comparatorIn this group, fluid will be administered according to the standard fluid calculation (4-2-1 rule).
Receives: Other: Standard fluid theraphy
Goal-directed fluid theraphyActive comparatorIn 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%.
Receives: Other: Goal-directed fluid theraphy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Epiglottic thickness

    Epiglottic thickness is the measurement of epiglottis by ultrasonography with a lineer probe.

    Measured: immediately before surgery

  2. Tongue thickness

    The measurement of tongue will be done by ultrasonography with a lineer probe.

    Measured: immediately before surgery

Secondary outcomes (4)
  1. number of participants with stridor

    Upper airway problem with the need of oxygen administration due to edema

    Measured: Within 24 hours postoperatively

  2. number of participants with reintubation

    Endotracheal intubation in the recovery period after general anethesia

    Measured: Within 24 hours postoperatively

  3. number of participants with cough

    Upper airway problem due to edema

    Measured: Within 24 hours postoperatively

  4. number of participants with hoarseness

    Upper airway problem due to edema of vocal cords

    Measured: Within 24 hours postoperatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Mar 2026
  2. Study start1 Mar 2023
  3. Primary completion1 Sep 2023
  4. Study completion1 Oct 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized, controlled, double-blinded clinical trial
Masking
Single blind
Who is masked
Participant
Enrolment
145 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07477392
Sponsor's protocol ID
Nazlitez
Status last verified
Mar 2026
First submitted
6 Oct 2023
Last updated
17 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Prasad C, Radhakrishna N, Pandia MP, Khandelwal A, Singh GP, Bithal PK. The Effect of Goal-Directed Fluid Therapy versus Standard Fluid Therapy on the Cuff Leak Gradient in Patients Undergoing Complex Spine Surgery in Prone Position. J Neurosci Rural Pract. 2021 Sep 28;12(4):745-750. doi: 10.1055/s-0041-1735321. eCollection 2021 Oct.

    PubMed 34737510
  • Carsetti A, Sorbello M, Adrario E, Donati A, Falcetta S. Airway Ultrasound as Predictor of Difficult Direct Laryngoscopy: A Systematic Review and Meta-analysis. Anesth Analg. 2022 Apr 1;134(4):740-750. doi: 10.1213/ANE.0000000000005839.

    PubMed 34914641
  • Aaen AA, Voldby AW, Storm N, Kildsig J, Hansen EG, Zimmermann-Nielsen E, Jensen KM, Tibaek P, Mortensen A, Moller AM, Brandstrup B. Goal-directed fluid therapy in emergency abdominal surgery: a randomised multicentre trial. Br J Anaesth. 2021 Oct;127(4):521-531. doi: 10.1016/j.bja.2021.06.031. Epub 2021 Aug 11.

    PubMed 34389168

Questions about this trial

What is this clinical trial studying?

A study testing Standard fluid theraphy and Goal-directed fluid theraphy in people with Goal-directed Fluid Theraphy and Upper Airway Ultrasonography, run by Bozyaka Training and Research Hospital at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Epiglottic thickness (time frame: immediately before surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07477392, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2026.

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