Prone Positioning and Abdominal Binding on Lung and Muscle Protection in ARDS Patients During Spontaneous Breathing
NCT05826847 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36
Last updated 2024-01-02
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.
Conditions
- Acute Respiratory Distress Syndrome
- Mechanical Ventilation Complication
- ICU Acquired Weakness
Interventions
- PROCEDURE
-
Prone Positioning
Prone positioning will be performed according to ICU local protocol with trained provider teams.
- PROCEDURE
-
Thoracoabdominal 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
- PROCEDURE
-
Control
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 & Collaborators
-
Fondo Nacional de Desarrollo Científico y Tecnológico, Chile
collaborator OTHER_GOV -
University of Chile
lead OTHER
Principal Investigators
-
Rodrigo Cornejo · University of Chile
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-12-06
- Primary Completion
- 2026-03-31
- Completion
- 2026-04-30
Countries
- Chile
Study Locations
More Related Trials
-
Prevalence of Prone Positioning Use in ARDS Patients
NCT02842788 ·Status: COMPLETED
-
Effects of Extravascular Lung Water on Prone Position Efficacy in Patients With ARDS
NCT04635267 ·Status: UNKNOWN
-
Reverse Trendelenburg Positioning and Its Effect on Outcomes: a Retrospective Study of Consecutive Patients
NCT02984657 ·Status: COMPLETED
-
Clinical Impact of Different Duration Prone Postition Treatment for Patients With ARDS.
NCT04391387 ·Status: COMPLETED ·Phase: NA
-
Prone Position in infantS/Children With Acute Respiratory Distress Syndrome
NCT06020404 ·Status: UNKNOWN ·Phase: NA
-
Prone Positioning in COVID-19 Patients
NCT05150847 ·Status: UNKNOWN ·Phase: NA
-
Role of Pulmonary Perfusion on Tolerance to Supine Position in Patients With ARDS
NCT05408442 ·Status: COMPLETED
-
Lateral Positioning and Prone Positioning in ARDS Patients
NCT06647784 ·Status: RECRUITING ·Phase: NA
-
Improvement of Lung and Thoracic Compliance in ARDS Patients in Prone Position by Using Inflatable Air Bag
NCT05515484 ·Status: RECRUITING ·Phase: PHASE2
-
Different Effects of Three Recruitment Maneuvers on the Lung Heterogeneity of Acute Respiratory Distress Syndrome
NCT02387437 ·Status: UNKNOWN ·Phase: NA
-
Hemodynamic Effects of Two Modalities of Alveolar Recruitment Maneuvers - ICU Patients
NCT05365854 ·Status: UNKNOWN ·Phase: NA
-
Pressures During Prone Positions in Healthy Volunteers
NCT06025370 ·Status: COMPLETED ·Phase: NA
-
Effect of Prone Positioning on Mortality in Patients With Mild to Moderate Acute Respiratory Distress Syndrome.
NCT05056090 ·Status: UNKNOWN ·Phase: NA
-
Hemodynamic and Ventilatory Responses to Head-down Postural Drainage Position
NCT01668875 ·Status: COMPLETED ·Phase: NA
-
Artificial Increase in Chest Wall Elastance as an Alternative to Prone Positioning in Moderate-to-severe ARDS.
NCT03719937 ·Status: SUSPENDED ·Phase: NA
-
Chest and Abdominal Compression Versus PROne Position
NCT05327205 ·Status: UNKNOWN
-
A Prospective Clinical Study to Explore Response to Prone Positioning in ARDS Patients
NCT04692779 ·Status: COMPLETED
-
Early Use of Prone Position in ECMO for Severe ARDS
NCT04139733 ·Status: COMPLETED
-
Effect of PP in Patients With Ultra-low VT
NCT06215209 ·Status: RECRUITING
-
Reverse Trendelenburg Position Versus Semi-recumbent Position in Obese Critically Ill Patients
NCT04376047 ·Status: COMPLETED ·Phase: NA
-
PROne POsition and Volumetric CAPnography
NCT02816190 ·Status: COMPLETED
-
The Impact of Early Mobilization Protocol in Patients in the ICU
NCT01769846 ·Status: COMPLETED ·Phase: NA
-
Postural Recruitment Maneuver in Patients With Acute Respiratory Distress Syndrome Due to COVID-19 Infection
NCT04475068 ·Status: COMPLETED
-
Impact of Decreasing Respiratory Rate on Lung Injury Biomarkers in ARDS Patients
NCT04641897 ·Status: COMPLETED ·Phase: NA
-
Prone Position and Renal Resistive Index
NCT04286490 ·Status: COMPLETED ·Phase: NA