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

University of Nove de Julho1 个研究点分布在 1 个国家目标入组 112 人2024年7月31日

适应症Respiratory Failure

概览

阶段: 不适用
干预措施: 未指定
疾病 / 适应症: Respiratory Failure
发起方: University of Nove de Julho
入组人数: 112
试验地点: 1
主要终点: Length of stay in the intensive care unit (ICU)
状态: 招募中
最后更新: 去年

概览研究者入排标准结局指标研究点相似试验

概览

简要总结

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.

详细描述

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 patient's successful weaning from mechanical ventilation, or until the day of the patient's 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 patient's 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). P.S.: * 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 patient's 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 (ii)PO2/FiO2 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 count;8) Survival rate; 9) Local skin reactions; 10) Adverse events and serious adverse events. The statistical analysis will follow the intention-to-treat principles.

注册库

clinicaltrials.gov

开始日期

2024年7月31日

结束日期

2025年12月

最后更新

去年

研究类型

Interventional

研究设计

Parallel

性别

All

研究者

发起方

University of Nove de Julho

责任方

Principal Investigator

主要研究者

Ernesto Cesar Pinto Leal Junior

Full professor

University of Nove de Julho

入排标准

入选标准

•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

排除标准

•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;

结局指标

主要结局

Length of stay in the intensive care unit (ICU)

时间窗: From date of ICU admission until the date of discharge or date of death from any cause, whichever came first, assessed up to 28 days.

Number of days hospitalized in the ICU until discharge from ICU or death from any cause.

次要结局

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.)
Local skin reactions(After each treatment administration up to 28 days.)
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.)