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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05759013




Registration number
NCT05759013
Ethics application status
Date submitted
16/01/2023
Date registered
8/03/2023

Titles & IDs
Public title
Pivotal Evaluation of Abdominal Neuromuscular Electrical Stimulation (VentFree) for Weaning From Mechanical Ventilation
Scientific 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
Secondary ID [1] 0 0
CDMRP - PR21220
Secondary ID [2] 0 0
LM-VF-P3
Universal Trial Number (UTN)
Trial acronym
PREVENT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Respiration, Artificial 0 0
Ventilators, Mechanical 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Breath synchronized abdominal NMES
Treatment: Devices - Sham breath synchronized abdominal NMES

Experimental: VentFree Respiratory Muscle Stimulator - 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 that does not cause discomfort to the participant. Participant discomfort will be measured using a visual analog pain scale (VAS) with pain ratings from zero (no pain) to ten (worst pain). For participants who are unable to communicate their level of pain, the Behavioral Pain Scale (BPS) will be used. The stimulation will be titrated for each participant and each stimulation session. After the stimulation has been titrated, a visible or palpable contraction of the abdominal wall will be confirmed. The stimulation will be evaluated every 10(± 2) minutes after the start of each stimulation session and adjusted as necessary so that no discomfort is caused to the participant.

Sham comparator: Sham Respiratory Muscle Stimulator - 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.


Treatment: Devices: Breath synchronized abdominal NMES
Active abdominal stimulation will be applied for 30 minutes twice per day (minimum of four hours between stimulation sessions), five days per week, for 28 days or ICU discharge, whichever comes first.

Treatment: Devices: Sham breath synchronized abdominal NMES
Sham abdominal stimulation will be applied for 30 minutes twice per day (minimum of four hours between stimulation sessions), five days per week, for 28 days or ICU discharge, whichever comes first.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time from first FES treatment administration to successful liberation during the treatment period of 28 days or until ICU discharge, whichever occurs first.
Timepoint [1] 0 0
From first FES treatment to 28 days or ICU discharge, whichever occurs first
Secondary outcome [1] 0 0
Cough peak flow
Timepoint [1] 0 0
At 24 hours post-extubation
Secondary outcome [2] 0 0
Maximum expiratory pressure
Timepoint [2] 0 0
At 24 hours post-extubation
Secondary outcome [3] 0 0
Incidence of device-related adverse events
Timepoint [3] 0 0
From date of first FES treatment administration to date of hospital discharge or 90 days after treatment, whichever occurs first
Secondary outcome [4] 0 0
Time from first FES treatment administration to ICU discharge
Timepoint [4] 0 0
From date of first FES treatment administration to date of ICU discharge or 90 days after treatment, whichever occurs first
Secondary outcome [5] 0 0
Time from first FES treatment administration to hospital discharge
Timepoint [5] 0 0
From date of first FES treatment administration to date of hospital discharge or 90 days after treatment, whichever occurs first
Secondary outcome [6] 0 0
Incidence of patients who were successfully liberated from mechanical ventilation
Timepoint [6] 0 0
From date of first FES treatment administration to date of hospital discharge or 90 days after treatment, whichever occurs first
Secondary outcome [7] 0 0
Incidence of re-intubations
Timepoint [7] 0 0
From date of first FES treatment administration to 90 days after treatment
Secondary outcome [8] 0 0
Incidence of readmissions to the ICU
Timepoint [8] 0 0
From date of first FES treatment administration to 90 days after treatment
Secondary outcome [9] 0 0
Incidence of readmissions to the hospital
Timepoint [9] 0 0
From date of first FES treatment administration to 90 days after treatment
Secondary outcome [10] 0 0
Incidence of acute respiratory infections
Timepoint [10] 0 0
From date of first FES treatment administration to date of hospital discharge or 90 days after treatment, whichever occurs first
Secondary outcome [11] 0 0
Incidence of hospital acquired infections
Timepoint [11] 0 0
From date of first FES treatment administration to date of hospital discharge or 90 days after treatment, whichever occurs first
Secondary outcome [12] 0 0
Incidence of tracheostomy
Timepoint [12] 0 0
From date of first FES treatment administration to date of ICU discharge or 90 days after treatment, whichever occurs first
Secondary outcome [13] 0 0
Mortality
Timepoint [13] 0 0
From Date of first FES treatment administration to date of hospital discharge or 90 days after treatment, whichever occurs first
Secondary outcome [14] 0 0
Maximum inspiratory pressure
Timepoint [14] 0 0
At 24 hours post-extubation
Secondary outcome [15] 0 0
Mobility as assessed by the ICU Mobility Scale
Timepoint [15] 0 0
Date of ICU discharge or 90 days after treatment, whichever occurs first
Secondary outcome [16] 0 0
Quality of life as assessed by EQ-5D (Quality of Life Survey)
Timepoint [16] 0 0
At 90 days after treatment

Eligibility
Key inclusion criteria
1. Participant is = 22 years of age.
2. Participant has been receiving invasive mechanical ventilation for = 24 hours but = 72 hours prior to enrollment.
3. Participant or legally authorized representative is willing and able to provide written informed consent.
Minimum age
22 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Participant is scheduled or expected to be disconnected from mechanical ventilation = 24 hours after enrollment.
2. Participant has a BMI = 40.
3. Participant has no contraction of the abdominal wall muscles in response to abdominal FES as determined by ultrasound.
4. Participant has a pre-existing neuromuscular or muscular disorder that could affect the respiratory muscles (e.g., spinal cord injury or Guillain-Barré syndrome).
5. Participant has had open abdominal surgery = 4 weeks prior to enrollment.
6. Participant has open or damaged skin at area of electrode placements.
7. Participant has a pacemaker and/or implanted electronic device.
8. Participant has expected or diagnosed epilepsy.
9. Participant is being treated for anaphylaxis.
10. 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.
11. Participant is actively pharmacologically paralyzed at the time of enrollment. NOTE: Subjects receiving neuromuscular blockers may be enrolled after a = 12 hour washout period.
12. Participant is ventilated as a result of an uncomplicated elective surgery.
13. The primary reason for ICU admission is an alcohol or drug overdose without secondary complication.
14. Participant is tracheostomized at the time of enrollment.
15. Participant is on home non-invasive ventilation (except for CPAP for obstructive sleep apnea).
16. Participant has a life expectancy < 6 months based on medical history.
17. 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
18. Participant is unable or unwilling to comply with protocol requirements, including assessments, tests, and follow-up visits.
19. Participant has any other medical condition which in the opinion of the Investigator will make participation medically unsafe or interfere with the study results.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/02/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/03/2025
Actual
Sample size
Target
272
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Monash Medical Centre - Clayton
Recruitment hospital [2] 0 0
St. George Hospital - Kogarah
Recruitment hospital [3] 0 0
Prince of Wales Hospital - Randwick
Recruitment hospital [4] 0 0
Royal North Shore Hospital - St. Leonards
Recruitment postcode(s) [1] 0 0
- Clayton
Recruitment postcode(s) [2] 0 0
- Kogarah
Recruitment postcode(s) [3] 0 0
- Randwick
Recruitment postcode(s) [4] 0 0
- St. Leonards
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Illinois
Country [2] 0 0
United States of America
State/province [2] 0 0
Iowa
Country [3] 0 0
United States of America
State/province [3] 0 0
Massachusetts
Country [4] 0 0
United States of America
State/province [4] 0 0
Ohio
Country [5] 0 0
United States of America
State/province [5] 0 0
Pennsylvania
Country [6] 0 0
United States of America
State/province [6] 0 0
Tennessee
Country [7] 0 0
United States of America
State/province [7] 0 0
Texas
Country [8] 0 0
United States of America
State/province [8] 0 0
Washington

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Liberate Medical
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
United States Department of Defense
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Angus Mclachlan, PhD
Address 0 0
Liberate Medical
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05759013