Acute Respiratory FailureNCT04507425
High Flow Nasal Cannula With Noninvasive Ventilation
A study testing High-flow nasal cannula and HFNC plus non-invasive ventilation in people with Acute Respiratory Failure, run by University of Oklahoma at 1 site in United States.
Trial summary
This is a prospective, randomized, unblinded trial of trauma patients in the ICU who are identified as being at a high risk to develop acute respiratory failure. We hope that this study will help the study team to identify how best to use a more aggressive respiratory treatment strategy in a high risk trauma… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Acute Respiratory Failure
- What is being tested?
- High-flow nasal cannula and HFNC plus non-invasive ventilation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2020to 10 Jul 2023
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults at least 18 years of age
- Admission to an intensive care unit by the trauma surgery service
- Trauma patients receiving any respiratory therapies
- High risk patients, including intubation, post-operative, chronic cardiac or pulmonary comorbidities
- Thoracic injuries, including rib fractures, sternal fractures, spinal fractures, pulmonary contusions, pneumothorax, hemothorax, diaphragm injury
- Postoperative from thoracic surgery
Show all 9Show fewer
- Postoperative from spine surgery in patients without spinal cord injury
- Abdominal injuries requiring open abdominal surgery
- No contraindications to using high flow nasal cannula or noninvasive ventilation
Who cannot join
- Contraindication to using high flow nasal cannula or noninvasive ventilation
- Intolerance of pulmonary therapies
- No one able to give informed consent
- Long-term treatment with noninvasive ventilation prior to hospital admission
- "Do not intubate" order at time of extubation
- Unplanned extubation (accidental or self-extubation)
Show all 11Show fewer
- Age < 18 years of age
- Traumatic brain injury with GCS < 8
- Spinal cord injury
- Chronic neuromuscular disease
- Sinus precautions due to facial/sinus fractures
Trial locations and contacts
1 site in 1 country.
About this study
Official title: High Flow Nasal Cannula With Noninvasive Ventilation and Its Effect on High Risk Trauma Patients
This is a prospective, randomized, unblinded trial of trauma patients in the ICU who are identified as being at a high risk to develop acute respiratory failure.
We hope that this study will help the study team to identify how best to use a more aggressive respiratory treatment strategy in a high risk trauma population (thoracic trauma or trauma patients requiring thoracic surgery, spine surgery, or open abdominal procedures) to try and decrease the need for intubation with mechanical ventilation.
Read the detailed description
All patients consented will be randomly assigned into one of three groups: nasal cannula (control group, our current standard of care), high-flow nasal cannula, high-flow nasal cannula plus noninvasive ventilation.
After obtaining consent, patient will be randomized to interventions 1:1:1 within each of two groups: patients admitted to the ICU without being intubated OR intubated patients undergoing an extubation.
Randomization will be managed through RedCap. After consent, the treating clinician will log into RedCap to obtain the patient's treating assignment.
The primary outcome of interest is failure of conservative ventilation intervention in prevention of initial intubation or prevention of reintubation.
A chart review of all enrolled patients will be done quarterly to assess morbidity, mortality, and outcomes.
No placebo will be used as all qualifying patients will be placed on nasal cannula, high-flow nasal cannula, or high-flow nasal cannula plus noninvasive ventilation. All other treatments will be standard of care.
Participants in the study will continue until the patient is discharged from the trauma ICU.
The study will end when the last person enrolled has been discharged from the trauma ICU. If patient's participation ends prematurely, available data will be entered into the database and evaluated appropriately.
This study will take place at the OU Medical Center (OUMC) among patients admitted to the Trauma Intensive Care Unit.
Consent for study enrollment will take place at OUMC during discussion with physician providing trauma care and the patient, family member, or next of kin consenting for the study.
The following data will be collected and recorded: Supplemental oxygen requirements, Date/Time of arrival, Date/Time of Admission to ICU, Date/Time of intubation procedure, Date/Time of extubation, Ventilator settings, Duration of intubation, Comorbidities, PaCO2 values, PaO2 values, Vital signs at arrival and at admission to ICU, Age,Gender, Weight, Height, BMI, Traumatic injuries, Diagnosis, Past medical history/medical co-morbidities, Glasgow coma scale, Oxygen saturation, Negative inspiratory force score, Rapid shallow breathing index score, Pulmonary treatments, including an intolerance to therapy, Injury Severity Score (ISS) and/or Abbreviated Injury Scale (AIS).
- Conditions
- Acute Respiratory Failure
- Being tested
- Standard of Care - Nasal Cannula, High-flow nasal cannula, HFNC plus non-invasive ventilation
- Keywords
- acute respiratory failure, mechanical ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of Care - Nasal CannulaOther
Standard of care. Flexible tube to provide extra oxygen when patients need a little help, but are not in respiratory distress.
High-flow nasal cannulaOther
Also called HFNC
Same as nasal cannula, except the oxygen is heated or humidified and the flow is stronger, pushing air into the lungs to help keep the airway open.
HFNC plus non-invasive ventilationOther
This method uses HFNC as described above and adds noninvasive ventilation which is similar to CPAP machine and uses a mask rather than having to intubate (putting a tube down your throat to keep your airway from collapsing).
| Study group | Role | What they receive |
|---|---|---|
| Not Intubated | Active comparator | Patients admitted with a trauma injury who do not need to be intubated to receive treatment. Intubated means putting a tube down your throat to keep your airway from collapsing. Participants will be randomized to receive one of the three interventions in this arm. Receives: Other: Standard of Care - Nasal Cannula; Other: High-flow nasal cannula; Other: HFNC plus non-invasive ventilation |
| Intubated Patients Undergoing Extubation | Active comparator | Patients admitted with a trauma injury who had to be intubated for treatment of their injury. Interventions administered after the tube is extubated (removed from throat). Participants will be randomized to receive one of the three interventions in this arm. Receives: Other: Standard of Care - Nasal Cannula; Other: High-flow nasal cannula; Other: HFNC plus non-invasive ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
failure rates-nonintubated patients
Among injured patients admitted to the intensive care unit (ICU) without being intubated, do failure rates within the first 48 hours of ICU admission differ with respect to type of initial respiratory intervention: nasal cannula, high-flow nasal cannula (HFNC), or HFNC plus non-invasive ventilation (BiPAP). Failure is defined as escalation to intubation.
Measured: first 48 hours
failure rates-intubated patients
Among injured patients arriving intubated or who undergo intervention after hospital arrival, do failure rates within the first 48 hours after extubation differ with respect to type of initial respiratory intervention: nasal cannula, high-flow nasal cannula (HFNC), or HFNC plus non-invasive ventilation (BiPAP). Failure is defined as requiring reintubation.
Measured: first 48 hours
Secondary outcomes (5)
Mortality
Assess mortality of enrolled patients by quarterly retrospective chart reviews.
Measured: Up to 2 years
Length of hospital stay
Compare length of hospitalization between groups
Measured: up to 60 days
Length of ICU stay
Compare length of ICU stay between groups
Measured: up to 30 days
Discharge location
was patient discharged to home, rehabilitation facility, skilled nursing, death; compare between groups
Measured: up to 60 days
Complications
Compare complications (such as need to be mechanically ventilated, infections, etc.) between groups
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2020
- Study start1 Sep 2020
- Primary completion10 Jul 2023
- Study completion10 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Acute Respiratory FailureStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized into 1 of 3 interventions: nasal cannula, high flow nasal cannula, and high flow nasal cannula plus noninvasive ventilation within each of two groups: patients admitted to ICU without being intubated OR intubated patients undergoing an extubation.
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Celia Y Quang, MD, Principal investigator, University of Oklahoma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04507425
- Sponsor's protocol ID
- 12248
- Status last verified
- Nov 2023
- First submitted
- 25 Jul 2020
- Last updated
- 21 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Thille AW, Boissier F, Ben-Ghezala H, Razazi K, Mekontso-Dessap A, Brun-Buisson C, Brochard L. Easily identified at-risk patients for extubation failure may benefit from noninvasive ventilation: a prospective before-after study. Crit Care. 2016 Feb 26;20:48. doi: 10.1186/s13054-016-1228-2.
PubMed 26926168Thille AW, Muller G, Gacouin A, Coudroy R, Decavele M, Sonneville R, Beloncle F, Girault C, Dangers L, Lautrette A, Cabasson S, Rouze A, Vivier E, Le Meur A, Ricard JD, Razazi K, Barberet G, Lebert C, Ehrmann S, Sabatier C, Bourenne J, Pradel G, Bailly P, Terzi N, Dellamonica J, Lacave G, Danin PE, Nanadoumgar H, Gibelin A, Zanre L, Deye N, Demoule A, Maamar A, Nay MA, Robert R, Ragot S, Frat JP; HIGH-WEAN Study Group and the REVA Research Network. Effect of Postextubation High-Flow Nasal Oxygen With Noninvasive Ventilation vs High-Flow Nasal Oxygen Alone on Reintubation Among Patients at High Risk of Extubation Failure: A Randomized Clinical Trial. JAMA. 2019 Oct 15;322(15):1465-1475. doi: 10.1001/jama.2019.14901.
PubMed 31577036Xu Z, Li Y, Zhou J, Li X, Huang Y, Liu X, Burns KEA, Zhong N, Zhang H. High-flow nasal cannula in adults with acute respiratory failure and after extubation: a systematic review and meta-analysis. Respir Res. 2018 Oct 16;19(1):202. doi: 10.1186/s12931-018-0908-7.
PubMed 30326893Honrubia T, Garcia Lopez FJ, Franco N, Mas M, Guevara M, Daguerre M, Alia I, Algora A, Galdos P. Noninvasive vs conventional mechanical ventilation in acute respiratory failure: a multicenter, randomized controlled trial. Chest. 2005 Dec;128(6):3916-24. doi: 10.1378/chest.128.6.3916.
PubMed 16354864Halub ME, Spilman SK, Gaunt KA, Lamb KD, Jackson JA, Oetting TW, Sahr SM. High-flow nasal cannula therapy for patients with blunt thoracic injury: A retrospective study. Can J Respir Ther. 2016 Fall;52(4):110-113. Epub 2016 Nov 1.
PubMed 30996619Gaunt KA, Spilman SK, Halub ME, Jackson JA, Lamb KD, Sahr SM. High-Flow Nasal Cannula in a Mixed Adult ICU. Respir Care. 2015 Oct;60(10):1383-9. doi: 10.4187/respcare.04016. Epub 2015 Jun 9.
PubMed 26060320Lamb KD, Spilman SK, Oetting TW, Jackson JA, Trump MW, Sahr SM. Proactive Use of High-Flow Nasal Cannula With Critically Ill Subjects. Respir Care. 2018 Mar;63(3):259-266. doi: 10.4187/respcare.05793. Epub 2017 Dec 5.
PubMed 29208754
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Flow Nasal Cannula With Noninvasive Ventilation and Its Effect on High Risk Trauma Patients
- ClinicalTrials.gov ID
- NCT04507425
- Acronym / sponsor ID
- 12248
- Conditions
- Acute Respiratory Failure
- Keywords
- acute respiratory failure, mechanical ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 10 Jul 2023 (actual)
- Study completion
- 10 Jul 2023 (actual)
- First posted
- 11 Aug 2020 (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.
This is a prospective, randomized, unblinded trial of trauma patients in the ICU who are identified as being at a high risk to develop acute respiratory failure.
We hope that this study will help the study team to identify how best to use a more aggressive respiratory treatment strategy in a high risk trauma population (thoracic trauma or trauma patients requiring thoracic surgery, spine surgery, or open abdominal procedures) to try and decrease the need for intubation with mechanical ventilation.
Detailed description
All patients consented will be randomly assigned into one of three groups: nasal cannula (control group, our current standard of care), high-flow nasal cannula, high-flow nasal cannula plus noninvasive ventilation.
After obtaining consent, patient will be randomized to interventions 1:1:1 within each of two groups: patients admitted to the ICU without being intubated OR intubated patients undergoing an extubation.
Randomization will be managed through RedCap. After consent, the treating clinician will log into RedCap to obtain the patient's treating assignment.
The primary outcome of interest is failure of conservative ventilation intervention in prevention of initial intubation or prevention of reintubation.
A chart review of all enrolled patients will be done quarterly to assess morbidity, mortality, and outcomes.
No placebo will be used as all qualifying patients will be placed on nasal cannula, high-flow nasal cannula, or high-flow nasal cannula plus noninvasive ventilation. All other treatments will be standard of care.
Participants in the study will continue until the patient is discharged from the trauma ICU.
The study will end when the last person enrolled has been discharged from the trauma ICU. If patient's participation ends prematurely, available data will be entered into the database and evaluated appropriately.
This study will take place at the OU Medical Center (OUMC) among patients admitted to the Trauma Intensive Care Unit.
Consent for study enrollment will take place at OUMC during discussion with physician providing trauma care and the patient, family member, or next of kin consenting for the study.
The following data will be collected and recorded: Supplemental oxygen requirements, Date/Time of arrival, Date/Time of Admission to ICU, Date/Time of intubation procedure, Date/Time of extubation, Ventilator settings, Duration of intubation, Comorbidities, PaCO2 values, PaO2 values, Vital signs at arrival and at admission to ICU, Age,Gender, Weight, Height, BMI, Traumatic injuries, Diagnosis, Past medical history/medical co-morbidities, Glasgow coma scale, Oxygen saturation, Negative inspiratory force score, Rapid shallow breathing index score, Pulmonary treatments, including an intolerance to therapy, Injury Severity Score (ISS) and/or Abbreviated Injury Scale (AIS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomized into 1 of 3 interventions: nasal cannula, high flow nasal cannula, and high flow nasal cannula plus noninvasive ventilation within each of two groups: patients admitted to ICU without being intubated OR intubated patients undergoing an extubation.
| Arm | Type | Receives |
|---|---|---|
| Not Intubated | Active comparator | Other: Standard of Care - Nasal Cannula, Other: High-flow nasal cannula, Other: HFNC plus non-invasive ventilationPatients admitted with a trauma injury who do not need to be intubated to receive treatment. Intubated means putting a tube down your throat to keep your airway from collapsing. Participants will be randomized to receive one of the three interventions in this arm. |
| Intubated Patients Undergoing Extubation | Active comparator | Other: Standard of Care - Nasal Cannula, Other: High-flow nasal cannula, Other: HFNC plus non-invasive ventilationPatients admitted with a trauma injury who had to be intubated for treatment of their injury. Interventions administered after the tube is extubated (removed from throat). Participants will be randomized to receive one of the three interventions in this arm. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Adults at least 18 years of age
- Admission to an intensive care unit by the trauma surgery service
- Trauma patients receiving any respiratory therapies
- High risk patients, including intubation, post-operative, chronic cardiac or pulmonary comorbidities
- Thoracic injuries, including rib fractures, sternal fractures, spinal fractures, pulmonary contusions, pneumothorax, hemothorax, diaphragm injury
Key exclusion criteria (11 listed)
- Contraindication to using high flow nasal cannula or noninvasive ventilation
- Intolerance of pulmonary therapies
- No one able to give informed consent
- Long-term treatment with noninvasive ventilation prior to hospital admission
- "Do not intubate" order at time of extubation
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 of Care - Nasal CannulaStandard of care. Flexible tube to provide extra oxygen when patients need a little help, but are not in respiratory distress. | Other | Intubated Patients Undergoing Extubation, Not Intubated |
| High-flow nasal cannulaAlso: HFNCSame as nasal cannula, except the oxygen is heated or humidified and the flow is stronger, pushing air into the lungs to help keep the airway open. | Other | Intubated Patients Undergoing Extubation, Not Intubated |
| HFNC plus non-invasive ventilationThis method uses HFNC as described above and adds noninvasive ventilation which is similar to CPAP machine and uses a mask rather than having to intubate (putting a tube down your throat to keep your airway from collapsing). | Other | Intubated Patients Undergoing Extubation, Not Intubated |
Primary outcome
failure rates-nonintubated patients
Time frame: first 48 hours
Among injured patients admitted to the intensive care unit (ICU) without being intubated, do failure rates within the first 48 hours of ICU admission differ with respect to type of initial respiratory intervention: nasal cannula, high-flow nasal cannula (HFNC), or HFNC plus non-invasive ventilation (BiPAP). Failure is defined as escalation to intubation.
failure rates-intubated patients
Time frame: first 48 hours
Among injured patients arriving intubated or who undergo intervention after hospital arrival, do failure rates within the first 48 hours after extubation differ with respect to type of initial respiratory intervention: nasal cannula, high-flow nasal cannula (HFNC), or HFNC plus non-invasive ventilation (BiPAP). Failure is defined as requiring reintubation.
5 secondary outcomes
Mortality
Time frame: Up to 2 years
Length of hospital stay
Time frame: up to 60 days
Length of ICU stay
Time frame: up to 30 days
Discharge location
Time frame: up to 60 days
Complications
Time frame: up to 2 years
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 21 Nov 2023.
- Results publication: PubMed 26926168Thille AW, Boissier F, Ben-Ghezala H, Razazi K, Mekontso-Dessap A, Brun-Buisson C, Brochard L. Easily identified at-risk patients for extubation failure may benefit from noninvasive ventilation: a prospective before-after study. Crit Care. 2016 Feb 26;20:48. doi: 10.1186/s13054-016-1228-2.
- Results publication: PubMed 31577036Thille AW, Muller G, Gacouin A, Coudroy R, Decavele M, Sonneville R, Beloncle F, Girault C, Dangers L, Lautrette A, Cabasson S, Rouze A, Vivier E, Le Meur A, Ricard JD, Razazi K, Barberet G, Lebert C, Ehrmann S, Sabatier C, Bourenne J, Pradel G, Bailly P, Terzi N, Dellamonica J, Lacave G, Danin PE, Nanadoumgar H, Gibelin A, Zanre L, Deye N, Demoule A, Maamar A, Nay MA, Robert R, Ragot S, Frat JP; HIGH-WEAN Study Group and the REVA Research Network. Effect of Postextubation High-Flow Nasal Oxygen With Noninvasive Ventilation vs High-Flow Nasal Oxygen Alone on Reintubation Among Patients at High Risk of Extubation Failure: A Randomized Clinical Trial. JAMA. 2019 Oct 15;322(15):1465-1475. doi: 10.1001/jama.2019.14901.
- Results publication: PubMed 30326893Xu Z, Li Y, Zhou J, Li X, Huang Y, Liu X, Burns KEA, Zhong N, Zhang H. High-flow nasal cannula in adults with acute respiratory failure and after extubation: a systematic review and meta-analysis. Respir Res. 2018 Oct 16;19(1):202. doi: 10.1186/s12931-018-0908-7.
- Results publication: PubMed 16354864Honrubia T, Garcia Lopez FJ, Franco N, Mas M, Guevara M, Daguerre M, Alia I, Algora A, Galdos P. Noninvasive vs conventional mechanical ventilation in acute respiratory failure: a multicenter, randomized controlled trial. Chest. 2005 Dec;128(6):3916-24. doi: 10.1378/chest.128.6.3916.
- Results publication: PubMed 30996619Halub ME, Spilman SK, Gaunt KA, Lamb KD, Jackson JA, Oetting TW, Sahr SM. High-flow nasal cannula therapy for patients with blunt thoracic injury: A retrospective study. Can J Respir Ther. 2016 Fall;52(4):110-113. Epub 2016 Nov 1.
- Results publication: PubMed 26060320Gaunt KA, Spilman SK, Halub ME, Jackson JA, Lamb KD, Sahr SM. High-Flow Nasal Cannula in a Mixed Adult ICU. Respir Care. 2015 Oct;60(10):1383-9. doi: 10.4187/respcare.04016. Epub 2015 Jun 9.
- Results publication: PubMed 29208754Lamb KD, Spilman SK, Oetting TW, Jackson JA, Trump MW, Sahr SM. Proactive Use of High-Flow Nasal Cannula With Critically Ill Subjects. Respir Care. 2018 Mar;63(3):259-266. doi: 10.4187/respcare.05793. Epub 2017 Dec 5.
- Individual participant dataSharing planned: No
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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.
Celia Y Quang, MD principal investigator
University of Oklahoma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-flow nasal cannula and HFNC plus non-invasive ventilation in people with Acute Respiratory Failure, run by University of Oklahoma at 1 site in United States.
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 9 inclusion and 11 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 21 Nov 2023. 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 United States. 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?
failure rates-nonintubated patients (time frame: first 48 hours). 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 NCT04507425, which also lists 7 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 21 Nov 2023.