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Prone Positioning and Abdominal Binding on Lung and Muscle Protection in ARDS Patients During Spontaneous Breathing

Effect of Prone Positioning and Abdominal Binding on Lung and Muscle Protection in ARDS Patients With ICU-acquired Weakness Transitioning From Controlled to Spontaneous Breathing

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05826847
Enrollment
36
Registered
2023-04-24
Start date
2023-12-06
Completion date
2026-04-30
Last updated
2024-01-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Respiratory Distress Syndrome, ICU Acquired Weakness, Mechanical Ventilation Complication

Brief summary

Ventilator-induced diaphragmatic dysfunction and intensive care unit (ICU)-acquired weakness are two consequences of prolonged mechanical ventilation and critical illness in patients with acute respiratory distress syndrome (ARDS). Both complicate the process of withdrawing mechanical ventilation, increase hospital mortality and cause chronic disability in survivors. During transition from controlled to spontaneous breathing, these complications of critical illness favor an abnormal respiratory pattern and recruit accessory respiratory muscles which may promote additional lung and muscle injury. The type of ventilatory support and positioning may affect the muscle dysfunction and patient-self-inflicted lung injury at spontaneous breathing onset. In that regard, ARDS patients with ventilator-induced diaphragmatic dysfunction and ICU-acquired weakness who are transitioning from controlled to partial ventilatory support probably present an abnormal respiratory pattern which exacerbates lung and muscle injury. Physiological-oriented ventilatory approaches based on prone positioning or semi recumbent positioning with abdominal binding at spontaneous breathing onset, could decrease lung and muscle injury by favoring a better neuromuscular efficiency, and preventing intense inspiratory efforts and high transpulmonary driving pressures, as well as high-magnitude pendelluft. In the current project, in addition to perform a multimodal description of the severity of ventilator-induced diaphragmatic dysfunction and ICU-acquired weakness in prolonged mechanically ventilated ARDS patients, prone positioning and supine plus thoracoabdominal binding at spontaneous breathing onset will be evaluated.

Detailed description

Study protocol will have three steps. The first step is a multimodal description to characterize ICU acquired weakness and ventilator-induced diaphragm dysfunction in prolonged mechanically ventilated ARDS patients at spontaneous breathing onset. The second step is a crossover clinical trial to test different ventilatory approaches oriented to improve physiological variables related to lung injury and diaphragm performance. The third step is a randomized controlled trial to test the effect of the previous ventilatory approaches on lung inflammatory response and biomarkers of lung and muscular injury. FIRST STEP: A multimodal physiological description will be performed in pressure support ventilation mode at spontaneous breathing onset. The assessments will include conventional electromyography; electrical activity of the diaphragm; ultrasound of respiratory and non-respiratory muscles; respiratory flow; tidal volume; airway, esophageal and gastric pressures; and hemodynamic and electric impedance tomography monitoring at the end of 2-hours of spontaneous breathing period. SECOND STEP: A controlled randomized crossover trial will assign patients to three strategies of 2-hours period on pressure support ventilation mode: A.- Control group: supine at 45º, B.- Thoracoabdominal binding: supine at 45º plus thoracoabdominal binding, C.- Prone positioning (without thoracoabdominal binding). These strategies will be performed under standard positive end-expiratory pressure (PEEP) (ARDSNet strategy) and individualized PEEP (obtained at the lowest combination of collapse and overdistension according to electrical impedance tomography), applied in random order. Therefore, each patient will receive the six approaches, with washout periods of 15-minutes in assisted/controlled ventilation. THIRD STEP: Patients will be randomized to one of the three ventilatory strategies previously defined, A.- Control group: supine at 45º, B.- Thoracoabdominal binding: supine at 45º plus abdominal binding, C.- Prone positioning. These three strategies will be applied under standard PEEP (ARDSNet strategy). Between crossover and pilot randomized controlled trial, the patients will remain under moderate sedation in pressure support ventilation mode receiving an individualized PEEP level.

Interventions

PROCEDUREProne Positioning

Prone positioning will be performed according to ICU local protocol with trained provider teams.

PROCEDUREThoracoabdominal Binding

Thoracoabdominal binding will be used in semi-recumbent position (supine at 45º) and titrated to obtain a 20-30% decrease in chest wall compliance and 1-3 cm H2O increase in end-expiratory gastric pressure during steady-state breathing

PROCEDUREControl

ARDS patients at spontaneous breathing onset on pressure support ventilation mode in supine position at 45º degrees, performed under standard PEEP according to ARDSNet strategy and individualized PEEP applied in random order.

Sponsors

Fondo Nacional de Desarrollo Científico y Tecnológico, Chile
CollaboratorOTHER_GOV
University of Chile
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Intervention model description

Three phase-study: 1. Multimodal physiological description 2. Randomized crossover trial 3. Pilot randomized trial

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Adult ARDS patients with moderate-severe ARDS on controlled protective mechanical ventilation for more than 3 days * Stable hemodynamics * Level of consciousness enough to initiate spontaneous breathing

Exclusion criteria

* Unstable hemodynamics * Tracheostomy * Abnormal level of consciousness * Central nervous system injury * Esophageal varices * Pregnancy * Contraindications for installation of electrical impedance tomography or ultrasound assessments

Design outcomes

Primary

MeasureTime frameDescription
(Third Phase) Change in Fast-Twitch Skeletal Muscle Troponin I Measured by ELISAAt baseline and after 24 hours of each ventilatory strategy during phase 3ELISA-based detection of fast-twitch skeletal muscle troponin I measured in plasma
(Second Phase) High-Magnitude PendelluftTwo hours on each ventilatory strategy during phase 2Frequency of high-magnitude pendelluft monitored by electrical impedance tomography
(Third Phase) Change in Inflammatory Biomarkers Measured by ELISA (IL-6, IL-8, TNF-α, IFN-γ, IL-18, IL-1β, Caspase-1, RAGE, Angiopoietin-1 and 2) and change in oxidative stress related biomarkers (F2 isoprostane)At baseline and after 24 hours of each ventilatory strategy during phase 3ELISA-based detection of inflammatory biomarkers (absolute and ratios) and oxidative stress related biomarkers (absolute and ratios) measured in plasma and in exhaled breath condensate
(Third Phase) Change in Regional Lung InflammationAt baseline and after 24 hours of each ventilatory strategy during phase 3Regional lung inflammation will be evaluated with dynamic positron emission tomography/computed tomography of fluoro-2-deoxy-D-glucose (18F-FDG) net uptake rate

Secondary

MeasureTime frameDescription
(Second Phase) Respiratory Mechanics VariablesTwo hours on each ventilatory strategy during phase 2Esophageal pressure swing, transdiaphragmatic pressure and transpulmonary driving pressure measured by a esophageal/gastric catheter
(Third Phase) Change in High-Magnitude PendelluftAt baseline and after 24 hours of each ventilatory strategy during phase 3Frequency of high-magnitude pendelluft monitored by electrical impedance tomography
(Third Phase) Change in Respiratory Mechanics VariablesAt baseline and after 24 hours of each ventilatory strategy during phase 3Esophageal pressure swing, transdiaphragmatic pressure and transpulmonary driving pressure measured by a esophageal/gastric catheter
(Third Phase) Change in Neuromechanical Coupling of DiaphragmAt baseline and after 24 hours of each ventilatory strategy during phase 3Change in neuromechanical coupling of diaphragm, which corresponds to the ratio between transdiaphragmatic pressure and electrical activity of the diaphragm measured by a esophageal/gastric catheter

Countries

Chile

Contacts

Primary ContactRodrigo Cornejo
racornej@gmail.com+56229788264

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026