ICU PatientsTriggerNCT04041817
Pulmonary and Ventilatory Effects of Trigger Modulation in Intubated ICU
A study testing Trigger setting of pressure support ventilation in people with ICU Patients and Intubation, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Pressure support ventilation allows intubated ICU patients to breathe spontaneously. Among specific settings, the adjustment of the trigger value (or threshold for triggering the ventilator) has not been explored to date. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ICU Patients, Intubation, Spontaneously Breathing
- What is being tested?
- Trigger setting of pressure support ventilation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 3 Apr 2019to 31 Jan 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- Patient hospitalized in the Intensive Care Unit of Clermont-Ferrand's Hospital
- Patients with mechanical invasive ventilation in spontaneous ventilation with inspiratory support (intubation or tracheostomy)
- Trigger level set to minimum
- Patient under sedation compatible with spontaneous ventilation (SV) with inspiratory support (AI) and positive end-expiratory pressure (PEP) Patient calm (RASS between -2 and 0) Consent for participation or consent from patient's next of kin or inclusion according to an emergency procedure Patient benefiting from the French social security scheme
Who cannot join
- Refusal to participate in the proposed study
- Contraindication to the installation of a nasogastric tube:
- Severe disorder of uncorrected blood clotting
- Known nasosinus lesion
- Oesophageal varices recently ligated (<48h)
- Contraindication to the use of the electro-impedancemetry technique by tomography
Show all 17Show fewer
- Thoracic lesions
- Chest dressings
- Pace-maker / Implantable Defibrillator
- Known lesion of central respiratory centers, including patients with neurological injury
- Patients with Acute Respiratory Distress Syndrome (according to Berlin criteria)
- Patients with restrictive or obstructive pulmonary pathology
- Patients admitted post-operatively for surgery that may affect the diaphragmatic function ( thoracic or abdominal supra-mesocolic)
- Patients with abdominal distention (ileus, intra-abdominal hyperpressure)
- Patient whose BMI is greater than 35 kg.m-2
- Pregnant patient
- Patient under guardianship,
Trial locations and contacts
1 site in 1 country.
France1 site
Service de Réanimation Adultes et Soins Continus
Clermont-Ferrand, 63000
About this study
Official title: Pulmonary and Ventilatory Effects of Trigger Modulation in Intubated ICU Patients Spontaneously Breathing With Pressure Support Ventilation. A Physiopathology Exploratory Study.
Pressure support ventilation allows intubated ICU patients to breathe spontaneously. Among specific settings, the adjustment of the trigger value (or threshold for triggering the ventilator) has not been explored to date. The trigger threshold corresponds to the sensitivity of the ventilator to detect patient's inspiratory effort and then deliver the predefined pressure support to inflate the lungs and deliver a tidal volume. The purpose of this study is to explore the influence of trigger level on pulmonary and ventilatory physio (-patho)logical parameters in spontaneously breathing ICU patients.
Read the detailed description
The use of invasive mechanical ventilation is one of the most frequent therapies in intensive care units (ICUs). There are several types of indications, depending on the failure: essentially neurological, hemodynamic or respiratory.
In recent years, the notion of lung damage induced by mechanical ventilation (VILI) has led to major changes in ventilator settings in both ICUs and operative rooms (Ors). The reduction of the tidal volume (TV) to 6-8 mL/kg of ideal body weight, the use of an individualized positive end-of-expiratory pressure (PEEP) and the possible use of pulmonary aeration optimization therapies (alveolar recruitment manoeuvres, prone positioning sessions...) have become essential to increase patient's survival.
Withdrawal of invasive mechanical ventilation remains a daily issue and traditionally requires the transition from fully controlled ventilation to pressure support ventilation. Among specific settings of the latter, the adjustment of the trigger value (or threshold for triggering the ventilator) has not been explored to date. The trigger threshold corresponds to the sensitivity of the ventilator to detect patient's inspiratory effort and then deliver the predefined pressure support to inflate the lungs and deliver a tidal volume. The lower (or more sensitive) the trigger threshold, the smallest patient's effort will be rewarded. On the other hand, the higher the threshold, the greater the inspiratory effort required from the patient. Usually, this value is set by default to the minimum level to avoid self-triggering of the ventilator. With the objective to optimize pulmonary aeration, the use of higher trigger levels could increase diaphragmatic work (with a potential re-training and reinforcement effect) and contribute to better alveolar recruitment in the postero-inferior territories that are traditionally the most impacted, following a higher diaphragmatic motion. The authors propose to explore the impact of different trigger levels on pulmonary aeration (evaluated by electrical impedance tomography) and ventilatory parameters, in order to validate our hypotheses and before considering a trial with the objective of defining individualized trigger levels, according to patient's respiratory mechanics and pulmonary parenchyma morphology, with potential benefits on ventilator weaning.
- Being tested
- Trigger setting of pressure support ventilation
- Keywords
- ICU, Pressure support ventilation, Spontaneous breathing, Trigger, Weaning of mechanical ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trigger setting of pressure support ventilationOther
Trigger variations will be performed following increasing steps of 3 L/min every 15 minutes, from 0.2 to 15 L/min (0.2 - 3 - 6 - 9 - 12 - 15).
| Study group | Role | What they receive |
|---|---|---|
| Trigger increasing steps | Experimental | Trigger variations will be performed following increasing steps of 2 L/min every 15 minutes. End expiratory lung volume and lung aeration will be conducted using elecrical impedance tomography. Diaphragmatic motion and thickening will be analyzed by ultrasonography. Work of breathing will be evaluated using gastric and oesophageal pressure measurements.
Measurements will be conducted during the last minute of each step. Receives: Other: Trigger setting of pressure support ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung volume (end expiratory lung volume, EELV) at each trigger level
The main endpoint is the difference between the lung volume (EELV) measured by electroimpedancemetry by tomography (EIT) at the end of each trigger level (15th minute) and the basal value measured at the beginning of the protocol
Measured: T0 (before the first trigger step)
Lung volume (end expiratory lung volume, EELV) at each trigger level
The main endpoint is the difference between the lung volume (EELV) measured by electroimpedancemetry by tomography (EIT) at the end of each trigger level (15th minute) and the basal value measured at the beginning of the protocol
Measured: T15 minutes (last minute of the trigger step n°1)
Lung volume (end expiratory lung volume, EELV) at each trigger level
The main endpoint is the difference between the lung volume (EELV) measured by electroimpedancemetry by tomography (EIT) at the end of each trigger level (15th minute) and the basal value measured at the beginning of the protocol
Measured: T30 minutes (last minute of the trigger step n°2)
Lung volume (end expiratory lung volume, EELV) at each trigger level
The main endpoint is the difference between the lung volume (EELV) measured by electroimpedancemetry by tomography (EIT) at the end of each trigger level (15th minute) and the basal value measured at the beginning of the protocol
Measured: T45 minutes (last minute of the trigger step n°3)
Lung volume (end expiratory lung volume, EELV) at each trigger level
The main endpoint is the difference between the lung volume (EELV) measured by electroimpedancemetry by tomography (EIT) at the end of each trigger level (15th minute) and the basal value measured at the beginning of the protocol
Measured: T60 minutes (last minute of the trigger step n°4)
Lung volume (end expiratory lung volume, EELV) at each trigger level
The main endpoint is the difference between the lung volume (EELV) measured by electroimpedancemetry by tomography (EIT) at the end of each trigger level (15th minute) and the basal value measured at the beginning of the protocol
Measured: T75 minutes (last minute of the trigger step n°5)
Lung volume (end expiratory lung volume, EELV) at each trigger level
The main endpoint is the difference between the lung volume (EELV) measured by electroimpedancemetry by tomography (EIT) at the end of each trigger level (15th minute) and the basal value measured at the beginning of the protocol
Measured: T90 minutes (last minute of the trigger step n°6)
Lung volume (end expiratory lung volume, EELV) at each trigger level
The main endpoint is the difference between the lung volume (EELV) measured by electroimpedancemetry by tomography (EIT) at the end of each trigger level (15th minute) and the basal value measured at the beginning of the protocol
Measured: T105 minutes (last minute of the trigger step n°7)
Lung volume (end expiratory lung volume, EELV) at each trigger level
The main endpoint is the difference between the lung volume (EELV) measured by electroimpedancemetry by tomography (EIT) at the end of each trigger level (15th minute) and the basal value measured at the beginning of the protocol
Measured: T120 minutes (last minute of the trigger step n°8)
Lung volume (end expiratory lung volume, EELV) at each trigger level
The main endpoint is the difference between the lung volume (EELV) measured by electroimpedancemetry by tomography (EIT) at the end of each trigger level (15th minute) and the basal value measured at the beginning of the protocol
Measured: T135 minutes (last minute of the trigger step n°9)
Lung volume (end expiratory lung volume, EELV) at each trigger level
The main endpoint is the difference between the lung volume (EELV) measured by electroimpedancemetry by tomography (EIT) at the end of each trigger level (15th minute) and the basal value measured at the beginning of the protocol
Measured: T150 minutes (last minute of the trigger step n°10)
Secondary outcomes (14)
Homogeneity of pulmonary aeration
Evaluation of homogeneity of pulmonary aeration with Center Of Ventilation by EIT
Measured: Through study completion, 150 minutes
Homogeneity of pulmonary aeration
Evaluation of homogeneity of pulmonary aeration with Global Inhomogeneity index by EIT
Measured: Through study completion, 150 minutes
Regional impedance variation
Evaluation of regional impedance variation (TIV: Tidal Impedance Variation) by EIT
Measured: Through study completion, 150 minutes
Atelectrauma
Assessement of atelectrauma (RVD: Regional Ventilation Delay) by EIT
Measured: Through study completion, 150 minutes
Lung volume variations
Evaluation of lung volume variations by EIT (EELI : End Expiratory Lung Impedance)
Measured: Through study completion, 150 minutes
Transpulmonary pressure
Evaluation of maximum transpulmonary pressure (alveolar stress)
Measured: Through study completion, 150 minutes
Alveolar strain defined as the ratio between tidal volume and Functional Residual Capacity
Alveolar strain defined as the ratio between tidal volume and Functional Residual Capacity
Measured: Through study completion, 150 minutes
Transpulmonary driving pressure
Evaluation of transpulmonary driving pressure
Measured: Through study completion, 150 minutes
Work of breathing
Evaluation of work of breathing (WOB) value (P01)
Measured: Through study completion, 150 minutes
Work of breathing
Evaluation of inspiratory occlusion pressure values (P01)
Measured: Through study completion, 150 minutes
Energy delivered
Evaluation of energy delivered to lungs patient
Measured: Measurement during the last minute of each trigger step
Diaphragm thickening
Evaluation of the diaphragmatic thickening by ultrasound
Measured: Through study completion, 150 minutes
Diaphragm motion
Evaluation of the diaphragmatic motion by ultrasound
Measured: Through study completion, 150 minutes
Patient's weight
Study of the impact of patient's weight
Measured: Through study completion, 150 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2019
- Study start3 Apr 2019
- Primary completion31 Jan 2023
- Study completion31 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ICU PatientsStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04041817
- Sponsor's protocol ID
- Trigger - RBHP 2018 GODET
- Other IDs
- 2018-A03307-48
- Acronym
- Trigger
- Status last verified
- Feb 2023
- First submitted
- 25 Jul 2019
- Last updated
- 17 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary and Ventilatory Effects of Trigger Modulation in Intubated ICU Patients Spontaneously Breathing With Pressure Support Ventilation. A Physiopathology Exploratory Study.
- ClinicalTrials.gov ID
- NCT04041817
- Acronym / sponsor ID
- Trigger / Trigger - RBHP 2018 GODET
- Keywords
- ICU, Pressure support ventilation, Spontaneous breathing, Trigger, Weaning of mechanical ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 3 Apr 2019 (actual)
- Primary completion
- 31 Jan 2023 (actual)
- Study completion
- 31 Jan 2023 (actual)
- First posted
- 1 Aug 2019 (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.
Pressure support ventilation allows intubated ICU patients to breathe spontaneously. Among specific settings, the adjustment of the trigger value (or threshold for triggering the ventilator) has not been explored to date. The trigger threshold corresponds to the sensitivity of the ventilator to detect patient's inspiratory effort and then deliver the predefined pressure support to inflate the lungs and deliver a tidal volume. The purpose of this study is to explore the influence of trigger level on pulmonary and ventilatory physio (-patho)logical parameters in spontaneously breathing ICU patients.
Detailed description
The use of invasive mechanical ventilation is one of the most frequent therapies in intensive care units (ICUs). There are several types of indications, depending on the failure: essentially neurological, hemodynamic or respiratory.
In recent years, the notion of lung damage induced by mechanical ventilation (VILI) has led to major changes in ventilator settings in both ICUs and operative rooms (Ors). The reduction of the tidal volume (TV) to 6-8 mL/kg of ideal body weight, the use of an individualized positive end-of-expiratory pressure (PEEP) and the possible use of pulmonary aeration optimization therapies (alveolar recruitment manoeuvres, prone positioning sessions...) have become essential to increase patient's survival.
Withdrawal of invasive mechanical ventilation remains a daily issue and traditionally requires the transition from fully controlled ventilation to pressure support ventilation. Among specific settings of the latter, the adjustment of the trigger value (or threshold for triggering the ventilator) has not been explored to date. The trigger threshold corresponds to the sensitivity of the ventilator to detect patient's inspiratory effort and then deliver the predefined pressure support to inflate the lungs and deliver a tidal volume. The lower (or more sensitive) the trigger threshold, the smallest patient's effort will be rewarded. On the other hand, the higher the threshold, the greater the inspiratory effort required from the patient. Usually, this value is set by default to the minimum level to avoid self-triggering of the ventilator. With the objective to optimize pulmonary aeration, the use of higher trigger levels could increase diaphragmatic work (with a potential re-training and reinforcement effect) and contribute to better alveolar recruitment in the postero-inferior territories that are traditionally the most impacted, following a higher diaphragmatic motion. The authors propose to explore the impact of different trigger levels on pulmonary aeration (evaluated by electrical impedance tomography) and ventilatory parameters, in order to validate our hypotheses and before considering a trial with the objective of defining individualized trigger levels, according to patient's respiratory mechanics and pulmonary parenchyma morphology, with potential benefits on ventilator weaning.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Trigger increasing steps | Experimental | Other: Trigger setting of pressure support ventilationTrigger variations will be performed following increasing steps of 2 L/min every 15 minutes. End expiratory lung volume and lung aeration will be conducted using elecrical impedance tomography. Diaphragmatic motion and thickening will be analyzed by ultrasonography. Work of breathing will be evaluated using gastric and oesophageal pressure measurements. Measurements will be conducted during the last minute of each step. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥18 years
- Patient hospitalized in the Intensive Care Unit of Clermont-Ferrand's Hospital
- Patients with mechanical invasive ventilation in spontaneous ventilation with inspiratory support (intubation or tracheostomy)
- Trigger level set to minimum
- Patient under sedation compatible with spontaneous ventilation (SV) with inspiratory support (AI) and positive end-expiratory pressure (PEP) Patient calm (RASS between -2 and 0) Consent for participation or consent from patient's next of kin or inclusion according to an emergency procedure Patient benefiting from the French social security scheme
Key exclusion criteria (17 listed)
- Refusal to participate in the proposed study
- Contraindication to the installation of a nasogastric tube:
- Contraindication to the use of the electro-impedancemetry technique by tomography
- Known lesion of central respiratory centers, including patients with neurological injury
- Patients with Acute Respiratory Distress Syndrome (according to Berlin criteria)
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 |
|---|---|---|
| Trigger setting of pressure support ventilationTrigger variations will be performed following increasing steps of 3 L/min every 15 minutes, from 0.2 to 15 L/min (0.2 - 3 - 6 - 9 - 12 - 15). | Other | Trigger increasing steps |
Primary outcome
Lung volume (end expiratory lung volume, EELV) at each trigger level
Time frame: T0 (before the first trigger step)
The main endpoint is the difference between the lung volume (EELV) measured by electroimpedancemetry by tomography (EIT) at the end of each trigger level (15th minute) and the basal value measured at the beginning of the protocol
Lung volume (end expiratory lung volume, EELV) at each trigger level
Time frame: T15 minutes (last minute of the trigger step n°1)
The main endpoint is the difference between the lung volume (EELV) measured by electroimpedancemetry by tomography (EIT) at the end of each trigger level (15th minute) and the basal value measured at the beginning of the protocol
Lung volume (end expiratory lung volume, EELV) at each trigger level
Time frame: T30 minutes (last minute of the trigger step n°2)
The main endpoint is the difference between the lung volume (EELV) measured by electroimpedancemetry by tomography (EIT) at the end of each trigger level (15th minute) and the basal value measured at the beginning of the protocol
Lung volume (end expiratory lung volume, EELV) at each trigger level
Time frame: T45 minutes (last minute of the trigger step n°3)
The main endpoint is the difference between the lung volume (EELV) measured by electroimpedancemetry by tomography (EIT) at the end of each trigger level (15th minute) and the basal value measured at the beginning of the protocol
Lung volume (end expiratory lung volume, EELV) at each trigger level
Time frame: T60 minutes (last minute of the trigger step n°4)
The main endpoint is the difference between the lung volume (EELV) measured by electroimpedancemetry by tomography (EIT) at the end of each trigger level (15th minute) and the basal value measured at the beginning of the protocol
Lung volume (end expiratory lung volume, EELV) at each trigger level
Time frame: T75 minutes (last minute of the trigger step n°5)
The main endpoint is the difference between the lung volume (EELV) measured by electroimpedancemetry by tomography (EIT) at the end of each trigger level (15th minute) and the basal value measured at the beginning of the protocol
Lung volume (end expiratory lung volume, EELV) at each trigger level
Time frame: T90 minutes (last minute of the trigger step n°6)
The main endpoint is the difference between the lung volume (EELV) measured by electroimpedancemetry by tomography (EIT) at the end of each trigger level (15th minute) and the basal value measured at the beginning of the protocol
Lung volume (end expiratory lung volume, EELV) at each trigger level
Time frame: T105 minutes (last minute of the trigger step n°7)
The main endpoint is the difference between the lung volume (EELV) measured by electroimpedancemetry by tomography (EIT) at the end of each trigger level (15th minute) and the basal value measured at the beginning of the protocol
Lung volume (end expiratory lung volume, EELV) at each trigger level
Time frame: T120 minutes (last minute of the trigger step n°8)
The main endpoint is the difference between the lung volume (EELV) measured by electroimpedancemetry by tomography (EIT) at the end of each trigger level (15th minute) and the basal value measured at the beginning of the protocol
Lung volume (end expiratory lung volume, EELV) at each trigger level
Time frame: T135 minutes (last minute of the trigger step n°9)
The main endpoint is the difference between the lung volume (EELV) measured by electroimpedancemetry by tomography (EIT) at the end of each trigger level (15th minute) and the basal value measured at the beginning of the protocol
Lung volume (end expiratory lung volume, EELV) at each trigger level
Time frame: T150 minutes (last minute of the trigger step n°10)
The main endpoint is the difference between the lung volume (EELV) measured by electroimpedancemetry by tomography (EIT) at the end of each trigger level (15th minute) and the basal value measured at the beginning of the protocol
14 secondary outcomes
Homogeneity of pulmonary aeration
Time frame: Through study completion, 150 minutes
Homogeneity of pulmonary aeration
Time frame: Through study completion, 150 minutes
Regional impedance variation
Time frame: Through study completion, 150 minutes
Atelectrauma
Time frame: Through study completion, 150 minutes
Lung volume variations
Time frame: Through study completion, 150 minutes
Transpulmonary pressure
Time frame: Through study completion, 150 minutes
Alveolar strain defined as the ratio between tidal volume and Functional Residual Capacity
Time frame: Through study completion, 150 minutes
Transpulmonary driving pressure
Time frame: Through study completion, 150 minutes
Work of breathing
Time frame: Through study completion, 150 minutes
Work of breathing
Time frame: Through study completion, 150 minutes
Energy delivered
Time frame: Measurement during the last minute of each trigger step
Diaphragm thickening
Time frame: Through study completion, 150 minutes
Diaphragm motion
Time frame: Through study completion, 150 minutes
Patient's weight
Time frame: Through study completion, 150 minutes
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 Feb 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trigger setting of pressure support ventilation in people with ICU Patients and Intubation, run by University Hospital, Clermont-Ferrand at 1 site in France.
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 5 inclusion and 17 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 Feb 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 France. 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?
Lung volume (end expiratory lung volume, EELV) at each trigger level (time frame: T0 (before the first trigger step)). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Feb 2023.