ICU severity of illness scores: APACHE, SAPS and MPM.
Jorge I F Salluh, Márcio Soares
https://pubmed.ncbi.nlm.nih.gov/25137401Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID07323472
Analysis of Respiratory Drive Activation, Ventilation, and Pulmonary Aeration Resulting From Body Lateralization in Critically Ill Patients Under Mechanical Ventilation
Led by University of Pernambuco · Updated on 2026-01-09
30
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of Pernambuco
Lead Sponsor
U
Universidade Federal de Pernambuco
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to understand how different body positions affect breathing effort, lung ventilation, and air distribution in critically ill adults who are on mechanical ventilation. It focuses on assessing the effects of Automatic Lateralization Therapy on respiratory drive and lung function compared to standard supine positioning. The study also evaluates whether combining this therapy with Flow Bias enhances respiratory and functional outcomes. The study is a quasi-experimental, non-randomized physiological intervention conducted in an ICU setting.
CONDITIONS
Brief Title
Body Lateralization and Its Effects on Respiratory Drive, Ventilation, and Pulmonary Aeration in Critically Ill Patients
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Patients of both sexes
- Aged 18 years or older
- Body mass index (BMI) between 18 and 35 kg/m9
- Under invasive mechanical ventilation via orotracheal tube for at least 24 hours and expected to remain on mechanical ventilation for at least 48 hours
- Sedated with Richmond Agitation-Sedation Scale (RASS) between -1 and -4
- Well adapted to protective ventilation in VCV or PSV modes
- Demonstrating neural respiratory drive with assisted breathing cycles
- Hemodynamically stable with specified blood pressure and heart rate ranges, with or without vasoactive drugs
- Respiratory stable without use of accessory muscles and target oxygen saturation achieved
- No need for nebulization or heated humidification at data collection
- Positive tolerance test for lateral decubitus positioning
- Chest circumference within specified size ranges (XS, S, M)
You will not qualify if you...
- Medical restrictions to body repositioning or use of Electrical Impedance Tomography (EIT) or surface electromyography (sEMG)
- Therapeutic failure
- History of spinal cord injury, brain injury, stroke with respiratory impairment prior to hospitalization
- Neurological diseases affecting respiratory muscle conduction
- Postural deformities, diaphragmatic abnormalities, or colostomy
- Unstable fractures in limbs or thorax
- Pleural effusion requiring drainage
- Presence of drains in thoracic or abdominal regions
- Unstable intracranial pressure
- Pregnancy
- 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
- Large masses in chest hemithorax
- Recent cardiopulmonary arrest under neuroprotection
- In total weaning phase from mechanical ventilation/tracheostomy/feeding tube or scheduled CT scan within 6 hours
- Intolerance to lateral positioning test
- Refusal to provide consent by legal representative
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Unilateral: 140 minutes (2 hours 20 minutes); Bilateral: 370 minutes (6 hours 10 minutes)
Participants undergo body positioning interventions including supine positioning with head elevation and automatic lateralization therapy with progressive body tilt angles. These interventions aim to evaluate respiratory drive activation, ventilation, and pulmonary aeration while being monitored for safety.
1 continuous intervention session per participant
Trial Site Locations
Total: 1 location
1
Hospital Geral Otávio de Freitas - Secretaria de Saúde de Pernambuco
Recife, Pernamu, Brazil, 50670-901
Actively Recruiting
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Research Team
S
Shirley Lima Campos, PhD
E
Emanuel Fernandes Ferreira da Silva Júnior, MSc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
NON_RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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