CuffNCT04948359
Determining Optimal Cuff Volume in Pediatric Patients
An observational study of Cuff and Airway Edema, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
Background and Aim: Cuffed endotracheal tubes with appropriate size, good cuff design and cuff pressure monitoring in pediatric patients can be used safely without increasing airway morbidity. Read more about this study
- Who is it for?
- Ages 2 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Cuff, Airway Edema, Children, Only
- What is being tested?
- Group I (The patients intubated with cuffed ETT of ID number 4.5), Group II (The patients intubated with cuffed ETT of ID number 5.0) and Group III ( The patients intubated with cuffed ETT of ID number 5.5)
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jul 2021to 1 Oct 2021
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 2 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Pediatric patients younger than 18 yr old who will be operated in our hospital and intubated with cuffed tubes numbered 4.5, 5.0, and 5.5 under general anesthesia
Who may be able to join
- Pediatric patients younger than 18 yr old who will be operated in our hospital and intubated with cuffed tubes numbered 4.5, 5.0, and 5.5 under general anesthesia are included in this study.
Who cannot join
- ASA physical status score of III and IV,
- Tracheostomy, airway obstruction or other airway anatomical abnormalities,
- Difficult intubation prediction,
- History of airway hyperreactivity or bronchial asthma,
- Body mass index above the 85th percentile and below the 5th percentile,
- Patients whose parents were unable to read, understand and sign the consent form or whose parents did not want to sign the consent form will not included in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Determining Optimal Cuff Volume for Cuffed Endotracheal Tubes Commonly Used in Pediatric Patients: a Prospective Observational Study
Background and Aim: Cuffed endotracheal tubes with appropriate size, good cuff design and cuff pressure monitoring in pediatric patients can be used safely without increasing airway morbidity. Inflating the endotracheal tube cuff with more than normal volume may lead to decreased capillary blood flow and mucosal damage, while inflating the endotracheal tube cuff with less than normal volume may lead to an increase in the risk of inadequate ventilation and pulmonary aspiration. In this study, we aimed to determine an optimal cuff inflation volume to achieve safe cuff pressure (20-25 cm H2O) in cuffed endotracheal tubes with an inner diameter of 4.5, 5.0, 5.5 mm, which are commonly used in pediatric anesthesia clinical practice.
Read the detailed description
Design:
This is a prospective, single blinded, observational study. In case of 2 independent variables in the multiple linear regression analysis, the required sample size was calculated as at least 40 in order to determine the large effect width (f2=0.35) at 0.80 power and 0.05 error levels. Since the study will be carried out with 3 different tube diameters, the sample size has been determined as 120 in total (G*Power software 3.1.9). In the Bland and Altman method, it was stated that when there are at least 100 observations, the 95% confidence level can be determined in the range of ±0.34s (where "s" is the standard deviation of the differences between the two measurements). For this reason, it is seen that the determined sample number of 120 is also sufficient for the Bland\&Altman method. Power analysis was made with G*Power 3.1.9.7 statistical package program; group=3, n=127 (n1=42, n2=43, n3=42), α=0.05, Effect Size (f)=0.34; power = 93%.
Methods: Pediatric patients younger than 18 yr old who will be operated in our hospital and intubated with cuffed tubes numbered 4.5, 5.0, and 5.5 under general anesthesia will be included in this prospective observational study. After standard monitoring in the supine position, anesthesia will be induced with a mixture of O2 / air (50/50%) and 8% Sevoflurane, and then vascular access will be established. Intravenous (IV) 2-3 mg/kg propofol and 1 μgr/kg fentanyl will be administered to patients with IV access. For muscle relaxation after loss of consciousness, 0.5 mg/kg rocuronium will be given IV. After the patients are paralyzed, a 3 cm roll pad will be placed under their shoulders and airway ultrasonography imaging will be performed with the head slightly extended and in the supine-neutral position. The linear probe will be placed transversely in the anterior neck of the patients and moved in a cefo-caudal direction to view the cricoid cartilage. The cricoid cartilage appears as a hypoechoic round structure with hyperechoic margins. At this level, the transverse diameter of the subglottic air column will be measured in millimeters (mm) on the USG image. The formulas in the literature and the subglottic transverse trachea diameter measured by ultrasound will be used to select the most appropriate endotracheal tube for the pediatric patients. After the appropriate cuffed tube is attached to the patient, the cuff will be inflated with air through a 5 milliliter (ml) injector, and cuff pressure will be measured with a cuff manometer. The optimal cuff volume will be determined by giving or withdrawing the 0.2 ml volume to ensure optimum cuff pressure (20-25 cmH2O) and this value will be recorded. Demographic data of the patients, subglottic transverse airway diameter measured by ultrasonography, endotracheal tube number placed in the patient, given cuff volume, measured cuff pressure value, tube change requirement, peak airway pressure, operation time and postoperative airway complications (sore throat, desaturation, stridor, hoarseness, cough) will be recorded.
- Conditions
- Cuff, Airway Edema, Children, Only, Tracheal Intubation Morbidity
- Being tested
- Group I (The patients intubated with cuffed ETT of ID number 4.5), Group II (The patients intubated with cuffed ETT of ID number 5.0), Group III ( The patients intubated with cuffed ETT of ID number 5.5)
- Keywords
- Airway ultrasound, Cuffed endotracheal tube, Cuff volume, Cuff pressure, Children
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group I (The patients intubated with cuffed ETT of ID number 4.5)Other
Groups are classified according to endotracheal tube ID numbers. Inflating the endotracheal tube cuff with more than normal volume leads to decreased capillary blood flow and mucosal damage, while inflating the endotracheal tube cuff with less than normal volume leads to insufficient ventilation of the patient and an increase in the risk of pulmonary aspiration. The cuff pressure safety range is recommended between 20-30 cmH2O to prevent gas leakage and the risk of aspiration. We aimed to determine the optimal cuff volume that ensures airway safety in pediatric patients intubated with a 4.5 size inner diameter (ID) endotracheal cuff tube. Choosing the appropriate tube for endotracheal intubation is of great importance, especially in children. In our study, the transverse diameter of the subglottic airway will be measured by USG for the selection of the appropriate ETT to be used for each patient (the formulas for the selection of ETT in the literature will be used)
Group II (The patients intubated with cuffed ETT of ID number 5.0)Other
Groups are classified according to endotracheal tube ID numbers. Inflating the endotracheal tube cuff with more than normal volume leads to decreased capillary blood flow and mucosal damage, while inflating the endotracheal tube cuff with less than normal volume leads to insufficient ventilation of the patient and an increase in the risk of pulmonary aspiration. The cuff pressure safety range is recommended between 20-30 cmH2O to prevent gas leakage and the risk of aspiration. We aimed to determine the optimal cuff volume that ensures airway safety in pediatric patients intubated with a 5.0 size inner diameter (ID) endotracheal cuff tube. Choosing the appropriate tube for endotracheal intubation is of great importance, especially in children. In our study, the transverse diameter of the subglottic airway will be measured by USG for the selection of the appropriate ETT to be used for each patient (the formulas for the selection of ETT in the literature will be used)
Group III ( The patients intubated with cuffed ETT of ID number 5.5)Other
Groups are classified according to endotracheal tube ID numbers. Inflating the endotracheal tube cuff with more than normal volume leads to decreased capillary blood flow and mucosal damage, while inflating the endotracheal tube cuff with less than normal volume leads to insufficient ventilation of the patient and an increase in the risk of pulmonary aspiration. The cuff pressure safety range is recommended between 20-30 cmH2O to prevent gas leakage and the risk of aspiration. We aimed to determine the optimal cuff volume that ensures airway safety in pediatric patients intubated with a 5.5 size inner diameter (ID) endotracheal cuff tube. Choosing the appropriate tube for endotracheal intubation is of great importance, especially in children. In our study, the transverse diameter of the subglottic airway will be measured by USG for the selection of the appropriate ETT to be used for each patient (the formulas for the selection of ETT in the literature will be used)
| Study group | Role | What they receive |
|---|---|---|
| Group I (The patients intubated with cuffed ETT of ID number 4.5) | Groups are classified according to endotracheal tube ID numbers. In this group we aimed to determine the optimal cuff volume that ensures airway safety in pediatric patients intubated with a 4.5 size internal diameter (ID) endotracheal cuff tube. Receives: Other: Group I (The patients intubated with cuffed ETT of ID number 4.5) | |
| Group II (The patients intubated with cuffed ETT of ID number 5.0) | Groups are classified according to endotracheal tube ID numbers. In this group we aimed to determine the optimal cuff volume that ensures airway safety in pediatric patients intubated with a 5.0 size internal diameter (ID) endotracheal cuff tube. Receives: Other: Group II (The patients intubated with cuffed ETT of ID number 5.0) | |
| Group III (The patients intubated with cuffed ETT of ID number 5.5) | Groups are classified according to endotracheal tube ID numbers. In this group we aimed to determine the optimal cuff volume that ensures airway safety in pediatric patients intubated with a 5.5 size internal diameter (ID) endotracheal cuff tube. Receives: Other: Group III ( The patients intubated with cuffed ETT of ID number 5.5) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Optimal intracuff volume
To obtain the minimum and optimal cuff volume that will provide adequate ventilation and protect from pulmonary aspiration in pediatric patients who is intubated with cuffed endotracheal tubes inner diameter of 4.5, 5.0, 5.5 mm.
Measured: during surgery
Formula for optimal cuff volume.
We would like to create a formula to calculate the estimated cuff volume that should be inflated within the safe cuff pressure range for each patient intubated with an ETT ID number 4.5, 5.0, and 5.5.
Measured: 15 minute
Secondary outcomes (2)
Formula for subglottic transverse tracheal diameter
We would like to develop a formula to predict subglottic transverse tracheal diameter with a regression model to be established by usin subglottic tracheal diameter data measured by USG in each patient.
Measured: 15 minute
Postoperative complications
The other secondary objective of this study is to examine correlation between cuff volume and postoperative complications
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2021
- Study start10 Jul 2021
- Primary completion1 Oct 2021
- Study completion1 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CuffStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kahir Güneş, Ankara City Hospital Bilkent
- Investigators
- Kahir Güneş, Principal investigator, Ankara City Hospital BilkentSengül Özmert, Study director, Ankara City Hospital BilkentFeyza Sever, Study director, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04948359
- Sponsor's protocol ID
- E2-21-76
- Status last verified
- Feb 2022
- First submitted
- 28 Jun 2021
- Last updated
- 16 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gunes K, Sever F, Ozmert S. Determining optimal cuff volume for cuffed endotracheal tubes commonly used in pediatric patients: A prospective observational study. Saudi Med J. 2024 Feb;45(2):147-153. doi: 10.15537/smj.2024.45.2.20230578.
PubMed 38309733
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining Optimal Cuff Volume for Cuffed Endotracheal Tubes Commonly Used in Pediatric Patients: a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT04948359
- Acronym / sponsor ID
- E2-21-76
- Conditions
- Cuff, Airway Edema, Children, Only, Tracheal Intubation Morbidity
- Keywords
- Airway ultrasound, Cuffed endotracheal tube, Cuff volume, Cuff pressure, Children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 10 Jul 2021 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 1 Oct 2021 (actual)
- First posted
- 1 Jul 2021 (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.
Background and Aim: Cuffed endotracheal tubes with appropriate size, good cuff design and cuff pressure monitoring in pediatric patients can be used safely without increasing airway morbidity. Inflating the endotracheal tube cuff with more than normal volume may lead to decreased capillary blood flow and mucosal damage, while inflating the endotracheal tube cuff with less than normal volume may lead to an increase in the risk of inadequate ventilation and pulmonary aspiration. In this study, we aimed to determine an optimal cuff inflation volume to achieve safe cuff pressure (20-25 cm H2O) in cuffed endotracheal tubes with an inner diameter of 4.5, 5.0, 5.5 mm, which are commonly used in pediatric anesthesia clinical practice.
Detailed description
Design:
This is a prospective, single blinded, observational study. In case of 2 independent variables in the multiple linear regression analysis, the required sample size was calculated as at least 40 in order to determine the large effect width (f2=0.35) at 0.80 power and 0.05 error levels. Since the study will be carried out with 3 different tube diameters, the sample size has been determined as 120 in total (G*Power software 3.1.9). In the Bland and Altman method, it was stated that when there are at least 100 observations, the 95% confidence level can be determined in the range of ±0.34s (where "s" is the standard deviation of the differences between the two measurements). For this reason, it is seen that the determined sample number of 120 is also sufficient for the Bland\&Altman method. Power analysis was made with G*Power 3.1.9.7 statistical package program; group=3, n=127 (n1=42, n2=43, n3=42), α=0.05, Effect Size (f)=0.34; power = 93%.
Methods: Pediatric patients younger than 18 yr old who will be operated in our hospital and intubated with cuffed tubes numbered 4.5, 5.0, and 5.5 under general anesthesia will be included in this prospective observational study. After standard monitoring in the supine position, anesthesia will be induced with a mixture of O2 / air (50/50%) and 8% Sevoflurane, and then vascular access will be established. Intravenous (IV) 2-3 mg/kg propofol and 1 μgr/kg fentanyl will be administered to patients with IV access. For muscle relaxation after loss of consciousness, 0.5 mg/kg rocuronium will be given IV. After the patients are paralyzed, a 3 cm roll pad will be placed under their shoulders and airway ultrasonography imaging will be performed with the head slightly extended and in the supine-neutral position. The linear probe will be placed transversely in the anterior neck of the patients and moved in a cefo-caudal direction to view the cricoid cartilage. The cricoid cartilage appears as a hypoechoic round structure with hyperechoic margins. At this level, the transverse diameter of the subglottic air column will be measured in millimeters (mm) on the USG image. The formulas in the literature and the subglottic transverse trachea diameter measured by ultrasound will be used to select the most appropriate endotracheal tube for the pediatric patients. After the appropriate cuffed tube is attached to the patient, the cuff will be inflated with air through a 5 milliliter (ml) injector, and cuff pressure will be measured with a cuff manometer. The optimal cuff volume will be determined by giving or withdrawing the 0.2 ml volume to ensure optimum cuff pressure (20-25 cmH2O) and this value will be recorded. Demographic data of the patients, subglottic transverse airway diameter measured by ultrasonography, endotracheal tube number placed in the patient, given cuff volume, measured cuff pressure value, tube change requirement, peak airway pressure, operation time and postoperative airway complications (sore throat, desaturation, stridor, hoarseness, cough) will be recorded.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group I (The patients intubated with cuffed ETT of ID number 4.5) | – | Other: Group I (The patients intubated with cuffed ETT of ID number 4.5)Groups are classified according to endotracheal tube ID numbers. In this group we aimed to determine the optimal cuff volume that ensures airway safety in pediatric patients intubated with a 4.5 size internal diameter (ID) endotracheal cuff tube. |
| Group II (The patients intubated with cuffed ETT of ID number 5.0) | – | Other: Group II (The patients intubated with cuffed ETT of ID number 5.0)Groups are classified according to endotracheal tube ID numbers. In this group we aimed to determine the optimal cuff volume that ensures airway safety in pediatric patients intubated with a 5.0 size internal diameter (ID) endotracheal cuff tube. |
| Group III (The patients intubated with cuffed ETT of ID number 5.5) | – | Other: Group III ( The patients intubated with cuffed ETT of ID number 5.5)Groups are classified according to endotracheal tube ID numbers. In this group we aimed to determine the optimal cuff volume that ensures airway safety in pediatric patients intubated with a 5.5 size internal diameter (ID) endotracheal cuff tube. |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Pediatric patients younger than 18 yr old who will be operated in our hospital and intubated with cuffed tubes numbered 4.5, 5.0, and 5.5 under general anesthesia
Key inclusion criteria (1 listed)
- Pediatric patients younger than 18 yr old who will be operated in our hospital and intubated with cuffed tubes numbered 4.5, 5.0, and 5.5 under general anesthesia are included in this study.
Key exclusion criteria (6 listed)
- ASA physical status score of III and IV,
- Tracheostomy, airway obstruction or other airway anatomical abnormalities,
- Difficult intubation prediction,
- History of airway hyperreactivity or bronchial asthma,
- Body mass index above the 85th percentile and below the 5th percentile,
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 |
|---|---|---|
| Group I (The patients intubated with cuffed ETT of ID number 4.5)Groups are classified according to endotracheal tube ID numbers. Inflating the endotracheal tube cuff with more than normal volume leads to decreased capillary blood flow and mucosal damage, while inflating the endotracheal tube cuff with less than normal volume leads to insufficient ventilation of the patient and an increase in the risk of pulmonary aspiration. The cuff pressure safety range is recommended between 20-30 cmH2O to prevent gas leakage and the risk of aspiration. We aimed to determine the optimal cuff volume that ensures airway safety in pediatric patients intubated with a 4.5 size inner diameter (ID) endotracheal cuff tube. Choosing the appropriate tube for endotracheal intubation is of great importance, especially in children. In our study, the transverse diameter of the subglottic airway will be measured by USG for the selection of the appropriate ETT to be used for each patient (the formulas for the selection of ETT in the literature will be used) | Other | Group I (The patients intubated with cuffed ETT of ID number 4.5) |
| Group II (The patients intubated with cuffed ETT of ID number 5.0)Groups are classified according to endotracheal tube ID numbers. Inflating the endotracheal tube cuff with more than normal volume leads to decreased capillary blood flow and mucosal damage, while inflating the endotracheal tube cuff with less than normal volume leads to insufficient ventilation of the patient and an increase in the risk of pulmonary aspiration. The cuff pressure safety range is recommended between 20-30 cmH2O to prevent gas leakage and the risk of aspiration. We aimed to determine the optimal cuff volume that ensures airway safety in pediatric patients intubated with a 5.0 size inner diameter (ID) endotracheal cuff tube. Choosing the appropriate tube for endotracheal intubation is of great importance, especially in children. In our study, the transverse diameter of the subglottic airway will be measured by USG for the selection of the appropriate ETT to be used for each patient (the formulas for the selection of ETT in the literature will be used) | Other | Group II (The patients intubated with cuffed ETT of ID number 5.0) |
| Group III ( The patients intubated with cuffed ETT of ID number 5.5)Groups are classified according to endotracheal tube ID numbers. Inflating the endotracheal tube cuff with more than normal volume leads to decreased capillary blood flow and mucosal damage, while inflating the endotracheal tube cuff with less than normal volume leads to insufficient ventilation of the patient and an increase in the risk of pulmonary aspiration. The cuff pressure safety range is recommended between 20-30 cmH2O to prevent gas leakage and the risk of aspiration. We aimed to determine the optimal cuff volume that ensures airway safety in pediatric patients intubated with a 5.5 size inner diameter (ID) endotracheal cuff tube. Choosing the appropriate tube for endotracheal intubation is of great importance, especially in children. In our study, the transverse diameter of the subglottic airway will be measured by USG for the selection of the appropriate ETT to be used for each patient (the formulas for the selection of ETT in the literature will be used) | Other | Group III (The patients intubated with cuffed ETT of ID number 5.5) |
Primary outcome
Optimal intracuff volume
Time frame: during surgery
To obtain the minimum and optimal cuff volume that will provide adequate ventilation and protect from pulmonary aspiration in pediatric patients who is intubated with cuffed endotracheal tubes inner diameter of 4.5, 5.0, 5.5 mm.
Formula for optimal cuff volume.
Time frame: 15 minute
We would like to create a formula to calculate the estimated cuff volume that should be inflated within the safe cuff pressure range for each patient intubated with an ETT ID number 4.5, 5.0, and 5.5.
2 secondary outcomes
Formula for subglottic transverse tracheal diameter
Time frame: 15 minute
Postoperative complications
Time frame: 1 hour
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 16 Feb 2022.
- Derived from this study: PubMed 38309733Gunes K, Sever F, Ozmert S. Determining optimal cuff volume for cuffed endotracheal tubes commonly used in pediatric patients: A prospective observational study. Saudi Med J. 2024 Feb;45(2):147-153. doi: 10.15537/smj.2024.45.2.20230578.
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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.
Kahir Güneş principal investigator
Ankara City Hospital Bilkent
Sengül Özmert study director
Ankara City Hospital Bilkent
Feyza Sever study director
Ankara City Hospital Bilkent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cuff and Airway Edema, run by Ankara City Hospital Bilkent 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 1 inclusion and 6 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 16 Feb 2022. 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?
Optimal intracuff volume (time frame: during 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 NCT04948359, which also lists 1 linked publication.
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 16 Feb 2022.