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).
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
- Conditions the study is for
- Goal-directed Fluid Theraphy, Upper Airway Ultrasonography
- 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
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 group | Role | What they receive |
|---|---|---|
| Standard fluid theraphy | Active comparator | In this group, fluid will be administered according to the standard fluid calculation (4-2-1 rule). Receives: Other: Standard fluid theraphy |
| Goal-directed fluid theraphy | Active comparator | 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%. Receives: Other: Goal-directed fluid theraphy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Epiglottic thickness
Epiglottic thickness is the measurement of epiglottis by ultrasonography with a lineer probe.
Measured: immediately before surgery
Tongue thickness
The measurement of tongue will be done by ultrasonography with a lineer probe.
Measured: immediately before surgery
Secondary outcomes (4)
number of participants with stridor
Upper airway problem with the need of oxygen administration due to edema
Measured: Within 24 hours postoperatively
number of participants with reintubation
Endotracheal intubation in the recovery period after general anethesia
Measured: Within 24 hours postoperatively
number of participants with cough
Upper airway problem due to edema
Measured: Within 24 hours postoperatively
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.
- First posted17 Mar 2026
- Study start1 Mar 2023
- Primary completion1 Sep 2023
- Study completion1 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Goal-directed Fluid TheraphyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Bozyaka Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nazlı Saruhan, Bozyaka Training and Research Hospital
- Investigators
- Nazlı N Deniz, MD, Principal investigator, Izmir Bozyaka Training and Research HospitalHande H Şahinkaya, MD, Study chair, Izmir Bozyaka Training and Research HospitalZeki T Tekgül, Prof., Study chair, Izmir Bozyaka Training and Research Hospital
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 34737510Carsetti 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 34914641Aaen 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
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Goal-directed Fluid Theraphy on Airway Ultrasonographic Measurements: Randomized, Controlled, Double-blinded Clinical Trial
- ClinicalTrials.gov ID
- NCT07477392
- Acronym / sponsor ID
- Nazlitez
- Keywords
- epiglottis thickness, tongue root thickness, pulse pressure variation, fluid theraphy, spinal surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- Bozyaka Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 1 Oct 2025 (actual)
- First posted
- 17 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized, controlled, double-blinded clinical trial
| Arm | Type | Receives |
|---|---|---|
| Standard fluid theraphy | Active comparator | Other: Standard fluid theraphyIn this group, fluid will be administered according to the standard fluid calculation (4-2-1 rule). |
| Goal-directed fluid theraphy | Active comparator | Other: Goal-directed fluid theraphyIn 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%. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18-65 years old
- ASA (American Association of Anesthesiologists) I and II
- Elective spine surgery in prone position
- Surgeries longer than 120 minutes
Key exclusion criteria (14 listed)
- Chronic pulmonary disease
- Renal dysfunction (glomerular filtration rate <30 ml/kg/min)
- Congestive heart failure (ejection fraction ≤35%)
- Serious arrhythmias
- Peripheral vascular disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard fluid theraphyIn 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 | Standard fluid theraphy |
| Goal-directed fluid theraphyIn 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. | Other | Goal-directed fluid theraphy |
Primary outcome
Epiglottic thickness
Time frame: immediately before surgery
Epiglottic thickness is the measurement of epiglottis by ultrasonography with a lineer probe.
Tongue thickness
Time frame: immediately before surgery
The measurement of tongue will be done by ultrasonography with a lineer probe.
4 secondary outcomes
number of participants with stridor
Time frame: Within 24 hours postoperatively
number of participants with reintubation
Time frame: Within 24 hours postoperatively
number of participants with cough
Time frame: Within 24 hours postoperatively
number of participants with hoarseness
Time frame: Within 24 hours postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
- Background: PubMed 34737510Prasad 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.
- Background: PubMed 34914641Carsetti 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.
- Background: PubMed 34389168Aaen 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nazlı N Deniz, MD principal investigator
Izmir Bozyaka Training and Research Hospital
Hande H Şahinkaya, MD study chair
Izmir Bozyaka Training and Research Hospital
Zeki T Tekgül, Prof. study chair
Izmir Bozyaka Training and Research Hospital
1 site in 1 country: see every site and its status.
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.