Intensive Care Units
Conditions
Keywords
Automatic lateralization therapy, Critical illness, Continuous lateral rotation, Electrical impedance tomography
Brief summary
New devices have been used in intensive care to optimize respiratory function in critically ill patients, such as automatic lateralization therapy. However, the times and angles used vary widely, and there is no clear evidence of cardiovascular safety and immediate effects, which represents a gap in the literature. This quasi-experimental study aims to evaluate the imediact efficacy and cardiorespiratory safety of automatic lateralization therapy in critically ill patients under invasive mechanical ventilation. The primary outcomes include changes in ventilation distribution and end-expiratory impedance variation. Secondary outcomes include respiratory mechanics, vital signs, and adverse events.
Detailed description
Introduction: Electrical impedance tomography (EIT) enables real-time imaging of lung ventilation, guiding interventions such as automatic lateralization therapy. Despite its potential, evidence about immediate effects and safety is limited. Objective: To evaluate the imediact cardiorespiratory efficacy and safety of automatic lateralization therapy in critically ill patients. Method: Quasi-experimental, non-randomized, two-arm study. Participants aged ≥18 years, intubated and clinically stable, will undergo both interventions. Interventions: * Arm 1: Supine position with head elevated at 30°. * Arm 2: Automatic lateralization therapy using programmable bed angles (0°, 15°, and 30°), alternating sides. Outcomes: Ventilation distribution, impedance variation (ΔZ, ΔEELZ), respiratory mechanics, adverse events, and vital signs will be measured. Ethical approval has been granted (CAAE 70188523.0.0000.5200). Informed consent will be obtained from legal guardians.
Interventions
Program the bed to vary angle and time continuously during the intervention
OTHERSupine Positioning
In this intervention, participants will be positioned in the supine position with the head of the bed elevated at 30°
Sponsors
Universidade Federal de Pernambuco
Coordination for the Improvement of Higher Education Personnel
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Fundação de Amparo à Ciência e Tecnologia de Pernambuco
University of Pernambuco
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
This study is a quasi-experimental, before-and-after study, and contains a single group, in which the group itself is the control. There will be a comparison before, during and after the intervention.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Volunteers aged 18 or over; * Of both sexes; * Breathing through an orotracheal tube; * With respiratory and hemodynamic stability.
Exclusion criteria
* Patients with contraindications to change of position; * Acute spinal cord injury; * Unstable fractures and signs of intracranial hypertension; * Pregnant women; * Immediate postoperative period of thoracic, orthopedic and abdominal surgeries; * Use of drains; * Grade III obesity (BMI \> 40 kg/m2); * Suspected pulmonary thromboembolism; * Agitation and active bleeding.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Electrical impedance tomography (EIT): End-Expiratory Electrical Impedance Variation (ΔEELZ) | In the 5 minutes of each angulation, totaling 15 minutes in the unilateral morphofunctional pattern or 20 minutes in the bilateral morphofunctional pattern. | Represents the change in regional pulmonary aeration between the pre- and post-intervention moments. |
| Electrical impedance tomography (EIT): Ventilation Distribution Variation (ΔZ) | In the 5 minutes of each angulation, totaling 15 minutes in the unilateral morphofunctional pattern or 20 minutes in the bilateral morphofunctional pattern. | Represents the change in ventilation distribution before and after the intervention. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | In the 5 minutes of each angulation, totaling 15 minutes in the unilateral morphofunctional pattern or 20 minutes in the bilateral morphofunctional pattern. | Monitoring of serious and non-serious adverse events associated with the intervention through an adapted adverse event form |
| Respiratory Mechanics | In the 5 minutes of each angulation, totaling 15 minutes in the unilateral morphofunctional pattern or 20 minutes in the bilateral morphofunctional pattern. | Data provided through the mechanical ventilator and from inspiratory and expiratory pause maneuvers |
| Vital signs | In the 5 minutes of each angulation, totaling 15 minutes in the unilateral morphofunctional pattern or 20 minutes in the bilateral morphofunctional pattern. | Viewed on the multiparameter monitor |
Other
| Measure | Time frame | Description |
|---|---|---|
| Lung morphofunctional pattern | In the 5 minutes of each angulation, totaling 15 minutes in the unilateral morphofunctional pattern or 20 minutes in the bilateral morphofunctional pattern. | Type of pattern of lung alteration observed by functional electrical impedance tomography image (preserved, unilateral involvement, unilateral dorsal, bilateral, bilateral dorsal). |
Countries
Brazil
Outcome results
None listed