Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06454006
Status:
RECRUITING
Last Update Posted:
2024-06-12
First Post:
2024-05-28
Brief Title:
Effects of PBMT-sMF in Mechanically Ventilated Patients
Sponsor:
University of Nove de Julho
Organization:
University of Nove de Julho
Study Overview
Official Title:
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
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
1 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
2 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 patients successful weaning from mechanical ventilation or until the day of the patients death whichever occurs first
The data will be collected by a blinded assessor
Due to the nature of the condition being evaluated in this study the study assessment timeline is patient dependent and will therefore be unique to each patient
The study will comprise
1 pre-treatment evaluation phase before starting treatment
2 treatment administration phase two assessments after completion of 14 and 28 days of treatment
3 post-treatment evaluation phase any patient who is not discharged from the hospital or who does not die during the treatment administration and evaluation phase will proceed to the post-treatment administration phase The post-treatment phase will start on the day immediately following the patients last day in the treatment administration evaluation phase The post-treatment phase will end on the day that the patient is discharged from the hospital or the day that the patient dies prior to discharge from the hospital whichever occurs firs Therefore the duration of the post-treatment administration phase will vary by individual patient During the post-treatment evaluation period the following assessments will be recorded once every two weeks as applicable with the final post-treatment evaluation visit determined on an individual patient basis up to 2 years
PS
For patients whose successful weaning from mechanical ventilation occurs prior to completion of the 28-day administration protocol the endpoint assessment visit will occur on or after the day of successful weaning
For patients who die before completion of the 28-day administration protocol the endpoint assessment visit will include outcome measures recorded as close to the date of the patients death as possible
The investigators will analyze 1 Length of stay in the ICU 2 Diaphragm thickness 3 Length of stay in the hospital following ICU discharge 4 Length of time until weaning from mechanical ventilation 5 Mechanical ventilation parameters i Positive end-expiratory pressure levels PEEP and ii Fraction of inspired oxygen FiO2 6 Arterial blood gas analysis i Arterial partial pressure of oxygen PO2 and iiPO2FiO2 ratio 7 Vital signs blood pressure heart rate SpO2 blood glucose etc 8 Blood draw analysis C-reactive protein CRP Tumor necrosis factor-alpha TNF-α Vitamin D erythrocytes hemoglobin hematocrit leucocytes segmented neutrals eosinophiles basophiles lymphocytes monocytes platelet count8 Survival rate 9 Local skin reactions 10 Adverse events and serious adverse events
The statistical analysis will follow the intention-to-treat principles
One hundred and twelve patients will be randomly allocated to two treatment groups
1 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
2 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 patients successful weaning from mechanical ventilation or until the day of the patients death whichever occurs first
The data will be collected by a blinded assessor
Due to the nature of the condition being evaluated in this study the study assessment timeline is patient dependent and will therefore be unique to each patient
The study will comprise
1 pre-treatment evaluation phase before starting treatment
2 treatment administration phase two assessments after completion of 14 and 28 days of treatment
3 post-treatment evaluation phase any patient who is not discharged from the hospital or who does not die during the treatment administration and evaluation phase will proceed to the post-treatment administration phase The post-treatment phase will start on the day immediately following the patients last day in the treatment administration evaluation phase The post-treatment phase will end on the day that the patient is discharged from the hospital or the day that the patient dies prior to discharge from the hospital whichever occurs firs Therefore the duration of the post-treatment administration phase will vary by individual patient During the post-treatment evaluation period the following assessments will be recorded once every two weeks as applicable with the final post-treatment evaluation visit determined on an individual patient basis up to 2 years
PS
For patients whose successful weaning from mechanical ventilation occurs prior to completion of the 28-day administration protocol the endpoint assessment visit will occur on or after the day of successful weaning
For patients who die before completion of the 28-day administration protocol the endpoint assessment visit will include outcome measures recorded as close to the date of the patients death as possible
The investigators will analyze 1 Length of stay in the ICU 2 Diaphragm thickness 3 Length of stay in the hospital following ICU discharge 4 Length of time until weaning from mechanical ventilation 5 Mechanical ventilation parameters i Positive end-expiratory pressure levels PEEP and ii Fraction of inspired oxygen FiO2 6 Arterial blood gas analysis i Arterial partial pressure of oxygen PO2 and iiPO2FiO2 ratio 7 Vital signs blood pressure heart rate SpO2 blood glucose etc 8 Blood draw analysis C-reactive protein CRP Tumor necrosis factor-alpha TNF-α Vitamin D erythrocytes hemoglobin hematocrit leucocytes segmented neutrals eosinophiles basophiles lymphocytes monocytes platelet count8 Survival rate 9 Local skin reactions 10 Adverse events and serious adverse events
The statistical analysis will follow the intention-to-treat principles
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None