Analysis of Respiratory Drive Activation, Ventilation, and Pulmonary Aeration Resulting From Body Lateralization in Critically Ill Patients Under Mechanical Ventilation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Respiratory drive parameters: Surface electromyography (sEMG)
研究概览
简要总结
The goal of this quasi-experimental study is to investigate how different body positions, performed through Automatic Lateralization Therapy, affect respiratory drive, ventilation, and pulmonary aeration in critically ill adult patients under mechanical ventilation. The main questions this study aims to answer are:
- Does Automatic Lateralization Therapy, modify respiratory drive, as measured by P0.1, estimated Pmus, and sEMG of the diaphragm and parasternal muscles?
- Is there an association between respiratory drive, ventilation, and pulmonary aeration measured by Electrical Impedance Tomography (EIT) in different body positions promoted by Automatic Lateralization Therapy ?
Does combining Automatic Lateralization Therapy, with Flow Bias improve physiological and functional outcomes compared to Automatic Lateralization Therapy, without Flow Bias?
Participants will:
- Be positioned in different lateralization strategies using Automatic Lateralization Therapy, while under mechanical ventilation;
- Have respiratory parameters and ventilation images assessed by EIT and sEMG;
Participate only during their ICU stay, with no need for additional visits after discharge.
详细描述
Detailed Description:
Critically ill patients under mechanical ventilation frequently develop respiratory complications due to immobility and altered pulmonary mechanics. Automatic Lateralization Therapy has emerged as a promising physiologic intervention to optimize ventilation and reduce respiratory dysfunction in this population. However, its effects on respiratory drive activation remain poorly understood.
Objective:
To evaluate the effects of body lateralization on respiratory drive activation, ventilation, and pulmonary aeration in mechanically ventilated critically ill patients.
Methods and Design:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Apart from the participants and the researchers responsible for data analysis, no other role is blinded in the study.
The researchers responsible for carrying out the interventions and conducting the study are not blinded to the intervention conditions.
Blinding is applied only to:
- Participants: sedated and, therefore, unaware of the intervention received.
- Researchers responsible for data analysis: blinded to the intervention conditions during the evaluation of physiological and ventilatory parameters.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of both sexes will be included;
- •Aged ≥ 18 years;
- •BMI 18-35 kg/m²;
- •Under invasive mechanical ventilation via orotracheal tube for ≥ 24 hours and expected to remain on mechanical ventilatory support for at least 48 hours;
- •Sedated (Richmond Agitation-Sedation Scale [RASS] -1 to -4);
- •Well adapted to protective ventilation strategies in VCV or PSV modes;
- •Presenting neural respiratory drive evidenced by a drop in Delta Pocc and/or the presence of assisted cycles;
- •Hemodynamically stable (mean arterial pressure between 60-120 mmHg, systolic arterial pressure between 90-180 mmHg, diastolic arterial pressure between 60-100 mmHg, and heart rate between 50-150 bpm) with or without vasoactive drugs at the time of data collection (> 0.1 to 0.3 mcg/kg/min);
- •Respiratory stability, no use of accessory muscles and target SpO₂ achieved;
- •No indication for nebulization or heated humidification at the time of collection;
- •Positive tolerance test for lateral decubitus positioning;
- •Chest circumference of 78-87.9 cm (XS), 88-99.9 cm (S), or 100-111.9 cm (M).
排除标准
- •Patients presenting medical restrictions to body repositioning, or to the use of EIT or sEMG;
- •Those in therapeutic failure;
- •Individuals with spinal cord injury, brain injury, or stroke with a history of functional loss and respiratory impairment prior to hospitalization;
- •Neurological diseases affecting respiratory myoelectric conduction;
- •History of postural deformities, diaphragmatic abnormalities, or colostomy bag;
- •Unstable fracture (lower or upper limbs in proximal regions or thorax);
- •Pleural effusion requiring drainage;
- •Presence of drains in the thoracic and/or abdominal regions;
- •Unstable intracranial pressure;
- •Pregnant patients;
- •Immediate postoperative period of orthopedic surgeries;
- •Use of mucolytics;
- •Open ventriculostomy for drainage;
- •Uncontrolled agitation;
- •Pacemaker or implantable cardioverter-defibrillator;
- •Pneumothorax;
- •Use of neuromuscular blockers;
- •Active tuberculosis;
- •Traction devices;
- •Active bleeding;
- •Suspected or confirmed pulmonary embolism without prior treatment within 24 hours;
- •Presence of a large mass in the right and/or left hemithorax;
- •History of cardiopulmonary arrest within the past 24 hours under neuroprotection;
- •In the total weaning phase from IMV and/or tracheostomy and/or enteral feeding tube and/or scheduled CT scan within the next 6 hours;
- •Intolerance to the TLA test (SpO₂ drop <92% or ≥20% from baseline, need for FiO₂ increase >50% or ≥20% from baseline, need for PEEP increase, or hemodynamic instability within the first 5 minutes of lateralization testing);
- •Those who refuse to provide consent, as determined by the legal representative.
结局指标
主要结局
Respiratory drive parameters: Surface electromyography (sEMG)
时间窗: Unilateral: 140 minutes (2 hour 20 minutes) | Bilateral: 370 minutes (6 hour 10 minutes)
The respiratory drive parameter will be assessed using surface electromyographic (sEMG) activity of the respiratory muscles, including the diaphragm and parasternal intercostals, expressed in microvolts (µV) (Silva Junior et al., 2023). Data are given in: • µV: Microvolts Measurements will be performed during the first and last 5 minutes of each body angulation. Unilateral: 140 minutes \| Bilateral: 370 minutes. Following the sequence: Semi-seated 30°/20 minutes, Supine 0°/5 minutes, 15°/20 minutes, 30°/20 minutes, 15°/20 minutes, Supine 0°/5 minutes, and Semi-seated 30°/20 minutes, totaling 70 minutes per sequence plus 60 minutes of washout between sequences. This results in 140 minutes for patients undergoing Unilateral Lateralization Therapy and 370 minutes for patients undergoing Bilateral Lateralization Therapy.
Respiratory drive parameter: P0.1 (airway occlusion pressure during the first 100 ms of the inspiratory effort)
时间窗: Unilateral: 140 minutes (2 hour 20 minutes) | Bilateral: 370 minutes(6 hour 10 minutes)
The respiratory drive parameter will be assessed by P0.1(airway occlusion pressure during the first 100ms of the inspiratory effort,cmH₂O).P0.1 is the drop in airway pressure within 100 ms after the onset of inspiration and is considered a reliable, fast, and feasible bedside marker.The following values are considered: Normal: 1.5-3.5 cmH₂O; Low: \<1.0 cmH₂O(hypostimulated); High:\>4.0 cmH₂O (hyperstimulated)(CHEN et al.,2023). Data are given in: cmH₂O: centimeters of water Measurements will be performed during the first and last 5 minutes of each body angulation. Unilateral: 140 minutes \| Bilateral: 370 minutes. Following the sequence: Semi-seated 30°/20 minutes, Supine 0°/5 minutes, 15°/20 minutes, 30°/20 minutes, 15°/20 minutes, Supine 0°/5 minutes, and Semi-seated 30°/20 minutes, totaling 70 minutes per sequence plus 60 minutes of washout between sequences. This results in 140 minutes for patients undergoing Unilateral Lateralization Therapy and 370 minutes Bilateral.
Respiratory drive parameters: Pmus (estimated inspiratory muscle pressure)
时间窗: Unilateral: 140 minutes (2 hour 20 minutes) | Bilateral: 370 minutes (6 hour 10 minutes)
The respiratory drive will be assessed using Pmus (estimated inspiratory muscle pressure). Pmus is derived from the airway pressure drop during a brief inspiratory occlusion and reflects inspiratory effort. Reference ranges: Pmus \< 5 cmH₂O indicates over-assistance/low drive; Pmus ≤ 10 cmH₂O represents the diaphragmatic protection zone; Pmus \> 13-15 cmH₂O indicates excessive effort (Dianti, Bertoni ;Goligher, 2020). Data are given in: •cmH₂O: centimeters of water Measurements will be performed during the first and last 5 minutes of each body angulation. Unilateral: 140 minutes \| Bilateral: 370 minutes. Following the sequence: Semi-seated 30°/20 minutes, Supine 0°/5 minutes, 15°/20 minutes, 30°/20 minutes, 15°/20 minutes, Supine 0°/5 minutes, and Semi-seated 30°/20 minutes, totaling 70 minutes per sequence plus 60 minutes of washout between sequences. This results in 140 minutes for patients undergoing Unilateral Lateralization Therapy and 370 minutes for patients undergoing Bilateral
Pulmonary ventilation: Ventilation Impedance Change (ΔZ)
时间窗: Unilateral: 140 minutes (2 hour 20 minutes) | Bilateral: 370 minutes (6 hour 10 minutes)
ΔZ will be quantified using electrical impedance tomography (EIT). ΔZ represents the sum of impedance changes of all pixels within a predefined region of interest (ROI), corresponding to regional tidal ventilation. ROIs will include right anterior, left anterior, right posterior, and left posterior lung regions, and will also be categorized as dependent or non-dependent lung areas. Data will be expressed in arbitrary units (a.u.). Measurements will be performed during the first and last 5 minutes of each body angulation. Unilateral: 140 minutes \| Bilateral: 370 minutes. Following the sequence: Semi-seated 30°/20 minutes, Supine 0°/5 minutes, 15°/20 minutes, 30°/20 minutes, 15°/20 minutes, Supine 0°/5 minutes, and Semi-seated 30°/20 minutes, totaling 70 minutes per sequence plus 60 minutes of washout between sequences. This results in 140 minutes for patients undergoing Unilateral Lateralization Therapy and 370 minutes for patients undergoing Bilateral Lateralization Therapy.
Pulmonary aeration: End-Expiratory Lung Impedance Change (ΔEELZ)
时间窗: Unilateral: 140 minutes (2 hour 20 minutes) | Bilateral: 370 minutes (6 hour 10 minutes)
ΔEELZ will be assessed using electrical impedance tomography (EIT). ΔEELZ corresponds to the aggregate end-expiratory impedance (sum of pixel values) within each ROI, representing changes in end-expiratory lung volume. ROIs will include right anterior, left anterior, right posterior, and left posterior lung regions, grouped as dependent or non-dependent areas. Data will be expressed in arbitrary units (a.u.). Measurements will be performed during the first and last 5 minutes of each body angulation. Unilateral: 140 minutes \| Bilateral: 370 minutes. Following the sequence: Semi-seated 30°/20 minutes, Supine 0°/5 minutes, 15°/20 minutes, 30°/20 minutes, 15°/20 minutes, Supine 0°/5 minutes, and Semi-seated 30°/20 minutes, totaling 70 minutes per sequence plus 60 minutes of washout between sequences. This results in 140 minutes for patients undergoing Unilateral Lateralization Therapy and 370 minutes for patients undergoing Bilateral Lateralization Therapy.
次要结局
- Mechanical response associated with respiratory drive: Diaphragmatic excursion(Unilateral: 140 minutes (2 hour 20 minutes) | Bilateral: 370 minutes (6 hour 10 minutes))
- Mechanical response related to respiratory effort and lung stress: Dynamic transpulmonary driving pressure(Unilateral: 140 minutes (2 hour 20 minutes) | Bilateral: 370 minutes (6 hour 10 minutes))
- Driving Pressure (cmH₂O)(Unilateral: 140 minutes (2 hour 20 minutes) | Bilateral: 370 minutes (6 hour 10 minutes))
- Respiratory System Compliance (mL/cmH₂O)(Unilateral: 140 minutes (2 hours and 20 minutes) Bilateral: 370 minutes (6 hours and 10 minutes))
- Airway Resistance (cmH₂O/L/s)(Unilateral: 140 minutes (2 hours and 20 minutes) Bilateral: 370 minutes (6 hours and 10 minutes))
- Arterial pH(Baseline; immediately after Sequence 1; immediately after Sequence 2. Unit: pH units.)
- Partial pressure of oxygen (PaO₂)(Baseline; immediately after Sequence 1; immediately after Sequence 2.)
- Partial pressure of carbon dioxide (PaCO₂)(Baseline; immediately after Sequence 1; immediately after Sequence 2.)
- Bicarbonate (HCO₃-)(Baseline; immediately after Sequence 1; immediately after Sequence 2.)
- Lactate(Baseline; immediately after Sequence 1; immediately after Sequence 2.)
- Base Excess (BE)(Baseline; immediately after Sequence 1; immediately after Sequence 2.)
- PaO₂/FiO₂ ratio(Baseline; immediately after Sequence 1; immediately after Sequence 2.)
- Pulmonary Severity - LUS Score (Lung Ultrasound Score)(Baseline, immediately after Sequence 1, and immediately after Sequence 2.)
- Hemodynamic Instability Events(At any time during the intervention and immediately after completion.)
- Unplanned Removal of Devices(During the intervention.)
- Serious Adverse Events(During the intervention.)
- Psychomotor Agitation - Richmond Agitation-Sedation Scale (RASS Score)(Unilateral: 140 minutes (2 hour 20 minutes) | Bilateral: 370 min (6 hour 10 minutes))
- Oxygenation and Hypoxemia Events (SpO₂ Monitoring + Hypoxemia Criteria)(Continuous monitoring; events recorded at any time during the intervention.)
研究者
Shirley Lima Campos
Principal Researcher
University of Pernambuco