Effects of Photobiomodulation Therapy Combined With Static Magnetic Field in Reducing the Number of Days in the Intensive Care Unit (ICU) for Adult Patients Requiring Mechanical Ventilation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- University of Nove de Julho
- Enrollment
- 112
- Locations
- 1
- Primary Endpoint
- Length of stay in the intensive care unit (ICU)
Study Overview
Brief Summary
The goal of this clinical trial is to evaluate the effectiveness of photobiomodulation therapy combined with static magnetic field (PBMT-sMF) in adult patients who require mechanical ventilation. The main questions it aims to answer are:
(i) Does PBMT-sMF lower the length of stay in the intensive care unit (ICU) for mechanically ventilated patients? (ii) Does PBMT-sMF increase the diaphragm thickness in mechanically ventilated patients in the ICU?
Researches will compare active PBMT-sMF plus standard of care to a placebo PBMT-sMF plus standard of care to see if active PBMT-sMF works to prevent or retard disuse atrophy of the diaphragm during mechanical ventilation.
Detailed Description
To achieve the proposed objectives it will be performed a multi-center, randomized, triple-blinded (patients, therapists, outcome assessors), placebo-controlled trial, in patients who required mechanical ventilation.
One hundred and twelve patients will be randomly allocated to two treatment groups:
- Active treatment: Patients will receive treatment with the active PBMT-sMF combined with standard of care therapy for a mechanically ventilated patient in the ICU.
- Placebo treatment: Patients will receive treatment with the placebo PBMT-sMF combined with standard of care therapy for a mechanically ventilated patient in the ICU.
The randomization will occur immediately following patients qualification and prior to any additional study activities occurring.
The treatment administration protocol (28-day administration protocol) will comprise: 7-minute treatment administration per day on each consecutive day for four consecutive weeks, for a maximum of 28 consecutive treatments over 28 consecutive days, or until the day of the patient's successful weaning from mechanical ventilation, or until the day of the patient's death, whichever occurs first.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
A researcher will program the device (placebo or active) and will be instructed not to inform the patients, therapists or other researchers as to the type of treatment (placebo or active). Therefore, the patients, therapists, and the outcome assessors will be blinded to the type of treatment being administered to the patients. The sounds and signals emitted from the device as well as the information displayed on the screen will be identical, regardless of the type of treatment (placebo or active).
Eligibility Criteria
- Ages
- 21 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Legally authorized representative signed informed consent;
- •Male or female aged 21 years or older;
- •On mechanical ventilation through orotracheal intubation for no more than 72 hours prior to study enrollment or pending mechanical ventilation through orotracheal intubation;
- •Predicted to remain on mechanical ventilation for at least 48 hours (≥48 hours) from the time of study enrollment
Exclusion Criteria
- •Mechanical ventilation initiated longer than 72 hours prior to anticipated enrollment;
- •Body Mass Index (BMI) > 40 kg/m²;
- •Fever of 100.4°C or higher;
- •Situated in the prone position for 24 hours or longer during mechanical ventilation;
- •Prognosis of mortality within 72 hours, per the patient's physician;
- •Hypersensitivity to light;
- •Use of non-invasive ventilation, Continuous Positive Airway Pressure (CPAP) and/or Bilevel Positive Airway Pressure (BiPAP) device for ≥ 50% of the time over the preceding 6 months;
- •Tracheostomy;
- •Any one or more of the following present on both sides of the neck (bilaterally) at the intended treatment site(s): internal jugular (IJ) venous cannulation; incisions, significant bruising; burn(s); notable skin irritation/rash, or other skin condition that may place the subject at risk from harm from the device treatment;
- •Fracture, external or internal hemorrhage, or at risk of hemorrhage following acute trauma or fracture, or known or potential acute occult bleeding (e.g., gastric ulcer, intestine) in the intended treatment areas;
- •Metallic device implants or body penetrating metallic devices in the upper body/neck area whose location may interfere with the study device treatment administration. E.g., extracorporeal membrane oxygenation (ECMO) cannula;
- •Non-removable electrical/electronic device in the upper body/neck area that may interfere with the study device treatment administration, e.g., -implanted pacemaker or cardiac defibrillator;
- •Cardiogenic or septic shock with ongoing severe hemodynamic instability (according to the American College of Chest Physicians definition (that cannot be stabilized within the 48 hours enrollment period);
- •Conditions that may limit ultrasonographic assessment of diaphragmatic thickness, e.g., occluding chest drain, pleural effusion, pulmonary consolidation of the lower lobe(s);
- •Current cancer of any type;
- •Pregnancy;
- •Any comorbidity, co-existing condition or illness, or other factor that in the opinion of the study investigator may render the subject unsuitable for participation in the study;
- •Admission to the ICU within the last 12 months due to respiratory distress/failure;
- •Two or more admissions to the ICU within the prior 12 months for any reason;
- •Current participation in another clinical study.
Arms & Interventions
Placebo
Placebo treatment will be delivered using Multi Radiance® Medical PhotOxyl photoceutical medical device emitting a light source that is sufficient to be indistinguishable from the active comparator but does not deliver any therapeutic energy, combined with standard of care therapy for a mechanically ventilated patient in the ICU.
The treatment administration protocol comprises one 7-minute treatment administration per day on each consecutive day for four consecutive weeks, for a maximum of 28 consecutive treatments over 28 consecutive days, or until the day of the subject's successful weaning from mechanical ventilation, or until the day of the subject's death, whichever occurs first.
Intervention: Placebo PBMT-sMF (Device)
Active
Active treatment will be delivered using Multi Radiance® Medical PhotOxyl photoceutical medical device in active mode, combined with standard of care therapy for a mechanically ventilated patient in the ICU.
The treatment administration protocol comprises one 7-minute treatment administration per day on each consecutive day for four consecutive weeks, for a maximum of 28 consecutive treatments over 28 consecutive days, or until the day of the subject's successful weaning from mechanical ventilation, or until the day of the subject's death, whichever occurs first.
Intervention: Active PBMT-sMF (Device)
Outcomes
Primary Outcomes
Length of stay in the intensive care unit (ICU)
Time Frame: From date of ICU admission until the date of discharge of the ICU.
Number of days hospitalized in the ICU until discharge from ICU.
Secondary Outcomes
- Local skin reactions(After each treatment administration up to 28 days.)
- Arterial partial pressure of oxygen (PO2)/Fraction of inspired oxygen (FiO2) ratio(After 14 days of treatment; after 28 days of treatment; and once every two weeks until the date of successful weaning from MV or date of death, whichever came first, up to 2 years.)
- Erythrocytes(After 14 days of treatment; after 28 days of treatment; and once every two weeks after discharge from ICU until the date of discharge of hospital or death from any cause, whichever came first, up to 2 years.)
- Length of time until weaning from mechanical ventilation (MV)(After 14 days of treatment; after 28 days of treatment; and once every two weeks until the date of successful weaning from MV or date of death, whichever came first, up to 2 years.)
- Arterial partial pressure of oxygen (PO2)(After completion of 14 days of treatment; after completion of 28 days of treatment, and assessments once every two weeks until the date of successful weaning from mechanical ventilation or date of death, whichever came first, up to 2 years.)
- Eeosinophiles(After 14 days of treatment; after 28 days of treatment; and once every two weeks after discharge from ICU until the date of discharge of hospital or death from any cause, whichever came first, up to 2 years.)
- Monocytes(After 14 days of treatment; after 28 days of treatment; and once every two weeks after discharge from ICU until the date of discharge of hospital or death from any cause, whichever came first, up to 2 years.)
- Adverse events(Adverse events will be collected throughout study duration up to 2 years.)
- Length of stay in the hospital(Assessments once every two weeks after discharge from ICU until the date of discharge of hospital or date of death from any cause, whichever came first, up to 2 years.)
- Levels of positive end-expiratory pressure levels (PEEP)(After 14 days of treatment; after 28 days of treatment; and once every two weeks until the date of successful weaning from MV or date of death, whichever came first, up to 2 years.)
- Levels of fraction of inspired oxygen (FiO2)(After 14 days of treatment; after 28 days of treatment; and once every two weeks until the date of successful weaning from MV or date of death, whichever came first, up to 2 years.)
- Leucocytes(After 14 days of treatment; after 28 days of treatment; and once every two weeks after discharge from ICU until the date of discharge of hospital or death from any cause, whichever came first, up to 2 years.)
- Lymphocytes(After 14 days of treatment; after 28 days of treatment; and once every two weeks after discharge from ICU until the date of discharge of hospital or death from any cause, whichever came first, up to 2 years.)
- Survival rate(After 14 days of treatment; after 28 days of treatment; and once every two weeks after discharge from ICU until the date of discharge of hospital or death from any cause, whichever came first, up to 2 years.)
- Hemoglobin(After 14 days of treatment; after 28 days of treatment; and once every two weeks after discharge from ICU until the date of discharge of hospital or death from any cause, whichever came first, up to 2 years.)
- C-reactive protein (CRP)(After 14 days of treatment; after 28 days of treatment; and once every two weeks after discharge from ICU until the date of discharge of hospital or death from any cause, whichever came first, up to 2 years.)
- Hematocrit(After 14 days of treatment; after 28 days of treatment; and once every two weeks after discharge from ICU until the date of discharge of hospital or death from any cause, whichever came first, up to 2 years.)
- Segmented neutrals(After 14 days of treatment; after 28 days of treatment; and once every two weeks after discharge from ICU until the date of discharge of hospital or death from any cause, whichever came first, up to 2 years.)
- Platelet count(After 14 days of treatment; after 28 days of treatment; and once every two weeks after discharge from ICU until the date of discharge of hospital or death from any cause, whichever came first, up to 2 years.)
- End-expiratory diaphragm thickness(After 14 days of treatment; after 28 days of treatment; and once every two weeks after discharge from ICU until the date of discharge of hospital or death from any cause, whichever came first, up to 2 years.)
- Basophiles(After 14 days of treatment; after 28 days of treatment; and once every two weeks after discharge from ICU until the date of discharge of hospital or death from any cause, whichever came first, up to 2 years.)
Investigators
Ernesto Cesar Pinto Leal Junior
Full professor
University of Nove de Julho