Respiration, ArtificialPREVENTNCT05759013
Pivotal Evaluation of Abdominal Neuromuscular Electrical Stimulation (VentFree) for Weaning From Mechanical Ventilation
A study testing Breath synchronized abdominal FES in people with Respiration, Artificial and Ventilators, Mechanical, run by Liberate Medical at 27 sites in 4 countries.
Trial summary
The objective of this study is to evaluate the efficacy of the VentFree Respiratory Muscle Stimulator (VentFree) in critically ill adult patients who require invasive mechanical ventilation, when compared to sham. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Respiration, Artificial, Ventilators, Mechanical
- What is being tested?
- Breath synchronized abdominal FES
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 250 participants
- Where
- 27 sitesin 4 countries
- Study dates
- 15 Feb 2024to 1 May 2026
- 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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant is ≥ 22 years of age.
- Participant has been receiving invasive mechanical ventilation for ≥ 24 hours.
Who cannot join
- Participant has been receiving invasive mechanical ventilation for > 96 hours.
- Participant is scheduled or expected to be disconnected from mechanical ventilation ≤ 24 hours after enrollment.
- Participant was intubated for ≥ 24 hours during a prior episode of invasive mechanical ventilation during current hospitalization.
- Participant has a BMI ≥ 40 Kg/m2.
- Participant has no contraction of the abdominal wall muscles in response to abdominal FES as determined by ultrasound.
- Participant has a pre-existing neuromuscular or muscular disorder that could affect the respiratory muscles (e.g., spinal cord injury or Guillain-Barré syndrome).
Show all 22Show fewer
- Participant has had open abdominal surgery ≤ 4 weeks prior to enrollment.
- Participant has open or damaged skin at area of electrode placements.
- Participant has a pacemaker and/or implanted electronic device.
- Participant is known or expected to be pregnant. NOTE: A negative urine or blood pregnancy test will be documented during screening for women of child-bearing potential.
- Participant is actively pharmacologically paralyzed at the time of enrollment. NOTE: Participants receiving neuromuscular blockers may be enrolled after a ≥ 12-hour washout period.
- Participant is tracheostomized at the time of enrollment.
- Participant is on home non-invasive ventilation (except for CPAP or BiPAP for obstructive sleep apnea).
- Participant is receiving or expected to receive comfort measures (palliative, hospice, comfort care, etc.) at the time of screening or enrollment.
- Participant is participating in any of the following:
- A study with the same or similar primary endpoint
- A study investigating electrical stimulation or respiratory muscle therapy
- Any study in which the investigator determines may interfere with the results of this study
- Participant is unable or unwilling to comply with protocol requirements, including assessments, tests, and follow-up visits.
- Participant has any other medical condition which in the opinion of the Investigator will make participation medically unsafe or interfere with the study results.
- Participant or legally authorized representative is unwilling to provide written informed consent.
- Participant or legally authorized representative is unable to provide written informed consent.
Trial locations and contacts
27 sites in 4 countries.
27 sites in 4 countries
United States15 sites
Tufts Medical Center
Boston, Massachusetts, 02111
University of Cincinnati
Cincinnati, Ohio, 45221
Providence Regional Medical Center
Everett, Washington, 98201
Edward Hines, Jr. VA Hospital
Hines, Illinois, 60141
MD Anderson Cancer Center
Houston, Texas, 077030
Baylor College of Medicine
Houston, Texas, 77030
Houston Methodist Hospital
Houston, Texas, 77030
Memorial Hermann
Houston, Texas, 77030
University of Florida College of Medicine - Jacksonville
Jacksonville, Florida, 32206
MemorialCare Long Beach Medical Center
Long Beach, California, 90807
University of Louisville
Louisville, Kentucky, 40202
Loyola University
Maywood, Illinois, 60153
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Weill Cornell Medicine / New York Presbyterian Hospital
New York, New York, 10065
University of Pittsburgh
Pittsburgh, Pennsylvania, 15260
Australia5 sites
Monash Medical Centre
Clayton
Nepean Hospital
Kingswood
St. George Hospital
Kogarah
Prince of Wales Hospital
Randwick
Royal North Shore Hospital
St Leonards
Netherlands4 sites
Jeroen Bosch Ziekenhuis (JBZ)
's-Hertogenbosch
Canisius Wilhelmina Ziekenhuis (CWZ)
Nijmegen
Radboud University Medical Center
Nijmegen
Erasmus Medical Center
Rotterdam
France3 sites
Centre Hospitalier Universitaire d'Angers
Angers, 49933
Hôpital Saint Joseph Saint Luc
Lyon, 69365
Pitié-Salpêtrière University Hospital
Paris
About this study
Official title: A Randomized, Sham Controlled, Double-blinded, Multi-center Trial to Evaluate the Efficacy of the VentFree Respiratory Muscle Stimulator to Assist Ventilator Weaning in Critically Ill Patients
The objective of this study is to evaluate the efficacy of the VentFree Respiratory Muscle Stimulator (VentFree) in critically ill adult patients who require invasive mechanical ventilation, when compared to sham.
Read the detailed description
Approximately 40% of patients who receive invasive ventilation require more than four days of ventilator support. Every additional day of mechanical ventilation results in increased patient morbidity and mortality and increased economic cost. Mechanically ventilated patients often develop expiratory muscle weakness, which has been linked to failed extubation and weaning.
Neuromuscular electrical stimulation (NMES) uses electrical pulses to induce a muscle contraction and has been shown to reduce or retard muscle atrophy. NMES applied to the abdominal wall muscles has been shown to improve respiratory function and assist ventilator weaning in spinal cord injury. Liberate Medical has previously shown that NMES applied to the abdominal wall muscles in synchrony with exhalation is feasible in patients receiving invasive mechanical ventilation. This study is a pivotal evaluation of the efficacy of exhalation synchronized abdominal NMES to assist ventilator weaning in critically ill patients.
- Conditions
- Respiration, Artificial, Ventilators, Mechanical
- Being tested
- Breath synchronized abdominal FES, Sham breath synchronized abdominal FES
- Keywords
- Respiratory Muscle Stimulation, Mechanical Ventilation
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breath synchronized abdominal FESDevice
Also called VentFree Respiratory Muscle Stimulator
Active abdominal stimulation will be applied for 30 minutes twice per day (minimum of four hours between stimulation sessions), for a minimum of five days per week, for 28 days or ICU discharge, whichever comes first.
Sham breath synchronized abdominal FESDevice
Sham abdominal stimulation will be applied for 30 minutes twice per day (minimum of four hours between stimulation sessions), for a minimum of five days per week, for 28 days or ICU discharge, whichever comes first.
| Study group | Role | What they receive |
|---|---|---|
| VentFree Respiratory Muscle Stimulator | Experimental | In the VentFree treatment group, abdominal functional electrical stimulation (FES) will be applied with a frequency of 30 hertz (Hz) and a pulse width of 350µs to cause a strong visible or palpable muscle contraction. The stimulation amplitude will be set to 90% of the participant's maximum tolerable level Discomfort associated with the maximum tolerable level will be recorded on the VAS with pain ratings from zero (no pain) to ten (worst pain). In uncommunicative patients, the maximum tolerable level will be determined as the stimulation intensity that results in a BPS >4 or CPOT >2. The stimulation amplitude will be titrated for each participant and each stimulation session. The stimulation amplitude will be evaluated every 10 (± 2) minutes after the start of each stimulation session and adjusted as necessary to maintain a consistent level of visual contraction and to ensure that the stimulation intensity remains within the participant's maximum tolerable level. Receives: Device: Breath synchronized abdominal FES |
| Sham Respiratory Muscle Stimulator | Sham comparator | In the sham group, abdominal functional electrical stimulation (FES) will be set to cause sensory stimulation but no muscle contraction. Abdominal FES will be applied with a frequency of 30 hertz (Hz), a pulse width of 350 µs and a stimulation amplitude that does not cause abdominal wall muscle contraction. The stimulation amplitude will initially be set at 10 mA and reduced in steps of 2 milliamp (mA) until no muscle contraction is seen. Receives: Device: Sham breath synchronized abdominal FES |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time from first FES treatment administration to successful liberation during the treatment period of 28 days or until ICU discharge, whichever occurs first.
Successful liberation is defined as disconnection from mechanical ventilation that does not require invasive mechanical ventilation in the subsequent 7 days after disconnection, or until ICU discharge, or until live hospital discharge, whichever occurs first.
Measured: From first FES treatment to 28 days or ICU discharge, whichever occurs first
Secondary outcomes (16)
Cough peak flow
Cough peak flow measurement
Measured: At 24 hours post-extubation
Maximum expiratory pressure
Maximum expiratory pressure measurement
Measured: At 24 hours post-extubation
Incidence of device-related adverse events
Number of device-related adverse events
Measured: From date of first FES treatment administration to date of hospital discharge or 90 days after treatment, whichever occurs first
Time from first FES treatment administration to ICU discharge
Duration of first FES treatment administration to ICU discharge
Measured: From date of first FES treatment administration to date of ICU discharge or 90 days after treatment, whichever occurs first
Time from first FES treatment administration to hospital discharge
Duration of first FES treatment administration to hospital discharge
Measured: From date of first FES treatment administration to date of hospital discharge or 90 days after treatment, whichever occurs first
Incidence of patients who were successfully liberated from mechanical ventilation
Number of of patients who were successfully liberated from mechanical ventilation
Measured: From date of first FES treatment administration to date of hospital discharge or 90 days after treatment, whichever occurs first
Incidence of re-intubations
Number of re-intubations
Measured: From date of first FES treatment administration to 90 days after treatment
Incidence of readmissions to the ICU
Number of readmissions to the ICU
Measured: From date of first FES treatment administration to 90 days after treatment
Incidence of readmissions to the hospital
Number of readmissions to the hospital
Measured: From date of first FES treatment administration to 90 days after treatment
Incidence of acute respiratory infections
Number of participants that had diagnosed acute respiratory infections
Measured: From date of first FES treatment administration to date of hospital discharge or 90 days after treatment, whichever occurs first
Incidence of hospital acquired infections
Number of participants that had diagnosed hospital acquired infections
Measured: From date of first FES treatment administration to date of hospital discharge or 90 days after treatment, whichever occurs first
Incidence of tracheostomy
Number of participants that underwent tracheostomies
Measured: From date of first FES treatment administration to date of ICU discharge or 90 days after treatment, whichever occurs first
Mortality
Number of Deaths
Measured: From Date of first FES treatment administration to date of hospital discharge or 90 days after treatment, whichever occurs first
Maximum inspiratory pressure
Maximum inspiratory pressure measurement
Measured: At 24 hours post-extubation
Mobility as assessed by the ICU Mobility Scale
Mobility assessment score from 0 (participant is unable to move) - 10 (participant is able to walk independently)
Measured: Date of ICU discharge or 90 days after treatment, whichever occurs first
Quality of life as assessed by EQ-5D (Quality of Life Survey)
Five (5) level Quality of Life assessment ranging from Level 1 (indicating no problem) to Level 5 (indicating unable to/extreme problems)
Measured: At 90 days after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2023
- Study start15 Feb 2024
- Primary completion15 Feb 2026
- Study completion1 May 2026
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 Respiration, ArtificialStudies 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liberate Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
- Investigators
- Angus Mclachlan, PhD, Study director, Liberate Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05759013
- Sponsor's protocol ID
- LM-VF-P3
- Other IDs
- CDMRP - PR21220
- Acronym
- PREVENT
- Status last verified
- May 2026
- First submitted
- 16 Jan 2023
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
McCaughey EJ, McLachlan AJ, Cai J, Cohen Freue G, Demoule A, Gotur DB, Hill NS, Dimatteo C, Oliva SP, Patel MB, Girard TD, Heunks L. Randomised, sham-controlled, double-blinded, multicentre international trial to evaluate the efficacy of the Ventfree Respiratory Muscle Stimulator to assist ventilator weaning in critically ill patients: a study protocol of a randomised controlled trial. BMJ Open. 2026 Apr 21;16(4):e113540. doi: 10.1136/bmjopen-2025-113540.
PubMed 42014152
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Sham Controlled, Double-blinded, Multi-center Trial to Evaluate the Efficacy of the VentFree Respiratory Muscle Stimulator to Assist Ventilator Weaning in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT05759013
- Acronym / sponsor ID
- PREVENT / LM-VF-P3
- Conditions
- Respiration, Artificial, Ventilators, Mechanical
- Keywords
- Respiratory Muscle Stimulation, Mechanical Ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Liberate MedicalIndustry (pharma, biotech, devices)
- Collaborators
- United States Department of Defense
- Study start
- 15 Feb 2024 (actual)
- Primary completion
- 15 Feb 2026 (actual)
- Study completion
- 1 May 2026 (actual)
- First posted
- 8 Mar 2023 (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 objective of this study is to evaluate the efficacy of the VentFree Respiratory Muscle Stimulator (VentFree) in critically ill adult patients who require invasive mechanical ventilation, when compared to sham.
Detailed description
Approximately 40% of patients who receive invasive ventilation require more than four days of ventilator support. Every additional day of mechanical ventilation results in increased patient morbidity and mortality and increased economic cost. Mechanically ventilated patients often develop expiratory muscle weakness, which has been linked to failed extubation and weaning.
Neuromuscular electrical stimulation (NMES) uses electrical pulses to induce a muscle contraction and has been shown to reduce or retard muscle atrophy. NMES applied to the abdominal wall muscles has been shown to improve respiratory function and assist ventilator weaning in spinal cord injury. Liberate Medical has previously shown that NMES applied to the abdominal wall muscles in synchrony with exhalation is feasible in patients receiving invasive mechanical ventilation. This study is a pivotal evaluation of the efficacy of exhalation synchronized abdominal NMES to assist ventilator weaning in critically ill patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VentFree Respiratory Muscle Stimulator | Experimental | Device: Breath synchronized abdominal FESIn the VentFree treatment group, abdominal functional electrical stimulation (FES) will be applied with a frequency of 30 hertz (Hz) and a pulse width of 350µs to cause a strong visible or palpable muscle contraction. The stimulation amplitude will be set to 90% of the participant's maximum tolerable level Discomfort associated with the maximum tolerable level will be recorded on the VAS with pain ratings from zero (no pain) to ten (worst pain). In uncommunicative patients, the maximum tolerable level will be determined as the stimulation intensity that results in a BPS >4 or CPOT >2. The stimulation amplitude will be titrated for each participant and each stimulation session. The stimulation amplitude will be evaluated every 10 (± 2) minutes after the start of each stimulation session and adjusted as necessary to maintain a consistent level of visual contraction and to ensure that the stimulation intensity remains within the participant's maximum tolerable level. |
| Sham Respiratory Muscle Stimulator | Sham comparator | Device: Sham breath synchronized abdominal FESIn the sham group, abdominal functional electrical stimulation (FES) will be set to cause sensory stimulation but no muscle contraction. Abdominal FES will be applied with a frequency of 30 hertz (Hz), a pulse width of 350 µs and a stimulation amplitude that does not cause abdominal wall muscle contraction. The stimulation amplitude will initially be set at 10 mA and reduced in steps of 2 milliamp (mA) until no muscle contraction is seen. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Participant is ≥ 22 years of age.
- Participant has been receiving invasive mechanical ventilation for ≥ 24 hours.
Key exclusion criteria (22 listed)
- Participant has been receiving invasive mechanical ventilation for > 96 hours.
- Participant is scheduled or expected to be disconnected from mechanical ventilation ≤ 24 hours after enrollment.
- Participant was intubated for ≥ 24 hours during a prior episode of invasive mechanical ventilation during current hospitalization.
- Participant has a BMI ≥ 40 Kg/m2.
- Participant has no contraction of the abdominal wall muscles in response to abdominal FES as determined by ultrasound.
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 |
|---|---|---|
| Breath synchronized abdominal FESAlso: VentFree Respiratory Muscle StimulatorActive abdominal stimulation will be applied for 30 minutes twice per day (minimum of four hours between stimulation sessions), for a minimum of five days per week, for 28 days or ICU discharge, whichever comes first. | Device | VentFree Respiratory Muscle Stimulator |
| Sham breath synchronized abdominal FESSham abdominal stimulation will be applied for 30 minutes twice per day (minimum of four hours between stimulation sessions), for a minimum of five days per week, for 28 days or ICU discharge, whichever comes first. | Device | Sham Respiratory Muscle Stimulator |
Primary outcome
Time from first FES treatment administration to successful liberation during the treatment period of 28 days or until ICU discharge, whichever occurs first.
Time frame: From first FES treatment to 28 days or ICU discharge, whichever occurs first
Successful liberation is defined as disconnection from mechanical ventilation that does not require invasive mechanical ventilation in the subsequent 7 days after disconnection, or until ICU discharge, or until live hospital discharge, whichever occurs first.
16 secondary outcomes
Cough peak flow
Time frame: At 24 hours post-extubation
Maximum expiratory pressure
Time frame: At 24 hours post-extubation
Incidence of device-related adverse events
Time frame: From date of first FES treatment administration to date of hospital discharge or 90 days after treatment, whichever occurs first
Time from first FES treatment administration to ICU discharge
Time frame: From date of first FES treatment administration to date of ICU discharge or 90 days after treatment, whichever occurs first
Time from first FES treatment administration to hospital discharge
Time frame: From date of first FES treatment administration to date of hospital discharge or 90 days after treatment, whichever occurs first
Incidence of patients who were successfully liberated from mechanical ventilation
Time frame: From date of first FES treatment administration to date of hospital discharge or 90 days after treatment, whichever occurs first
Incidence of re-intubations
Time frame: From date of first FES treatment administration to 90 days after treatment
Incidence of readmissions to the ICU
Time frame: From date of first FES treatment administration to 90 days after treatment
Incidence of readmissions to the hospital
Time frame: From date of first FES treatment administration to 90 days after treatment
Incidence of acute respiratory infections
Time frame: From date of first FES treatment administration to date of hospital discharge or 90 days after treatment, whichever occurs first
Incidence of hospital acquired infections
Time frame: From date of first FES treatment administration to date of hospital discharge or 90 days after treatment, whichever occurs first
Incidence of tracheostomy
Time frame: From date of first FES treatment administration to date of ICU discharge or 90 days after treatment, whichever occurs first
Mortality
Time frame: From Date of first FES treatment administration to date of hospital discharge or 90 days after treatment, whichever occurs first
Maximum inspiratory pressure
Time frame: At 24 hours post-extubation
Mobility as assessed by the ICU Mobility Scale
Time frame: Date of ICU discharge or 90 days after treatment, whichever occurs first
Quality of life as assessed by EQ-5D (Quality of Life Survey)
Time frame: At 90 days after treatment
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 2 Jun 2026.
- Derived from this study: PubMed 42014152McCaughey EJ, McLachlan AJ, Cai J, Cohen Freue G, Demoule A, Gotur DB, Hill NS, Dimatteo C, Oliva SP, Patel MB, Girard TD, Heunks L. Randomised, sham-controlled, double-blinded, multicentre international trial to evaluate the efficacy of the Ventfree Respiratory Muscle Stimulator to assist ventilator weaning in critically ill patients: a study protocol of a randomised controlled trial. BMJ Open. 2026 Apr 21;16(4):e113540. doi: 10.1136/bmjopen-2025-113540.
- Individual participant dataSharing planned: No
Related trials for Respiration, Artificial
Not yet recruiting
Miniature In-line Respirator
Brain Death, Respiration, Artificial
Recruiting
Optimal Timing for Spontaneous Breathing Trials
Respiration, Artificial, Weaning
RecruitingObservational study
VENtilation Modalities During Transport of PostoperatIve CRITically Ill Patients to the ICU
Respiration, Artificial, Positive-Pressure Respiration
Not yet recruitingObservational study
Use of Connected Glasses to Help the Communication of Non Temporarily Speaking Patients in Intensive Care Unit : a Pilot Study
Mechanical Ventilation, Critical Care, Intensive Care
RecruitingObservational study
Can a Pain Monitor Predict When Postoperative Intensive Care Unit Patients Are Ready to Breathe on Their Own? A Pilot Study
Ventilator Weaning, Airway Extubation
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.
Angus Mclachlan, PhD study director
Liberate Medical
27 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breath synchronized abdominal FES in people with Respiration, Artificial and Ventilators, Mechanical, run by Liberate Medical at 27 sites in 4 countries.
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 2 inclusion and 22 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 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in United States, Australia, Netherlands, 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. Some participants in this study may receive a placebo. 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?
Time from first FES treatment administration to successful liberation during the treatment period of 28 days or until ICU discharge, whichever occurs first. (time frame: From first FES treatment to 28 days or ICU discharge, whichever occurs first). 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 NCT05759013, 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 2 Jun 2026; AzTrials last refreshed its copy on 8 Nov 2026.