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

NCT05826847 | Recruiting

• 1 other identifier: 1221829
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (4)

• (Second Phase) High-Magnitude Pendelluft

  Frequency of high-magnitude pendelluft monitored by electrical impedance tomography

  Two hours on each ventilatory strategy during phase 2

• (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)

  ELISA-based detection of inflammatory biomarkers (absolute and ratios) and oxidative stress related biomarkers (absolute and ratios) measured in plasma and in exhaled breath condensate

  At baseline and after 24 hours of each ventilatory strategy during phase 3

• (Third Phase) Change in Regional Lung Inflammation

  Regional lung inflammation will be evaluated with dynamic positron emission tomography/computed tomography of fluoro-2-deoxy-D-glucose (18F-FDG) net uptake rate

  At baseline and after 24 hours of each ventilatory strategy during phase 3

• (Third Phase) Change in Fast-Twitch Skeletal Muscle Troponin I Measured by ELISA

  ELISA-based detection of fast-twitch skeletal muscle troponin I measured in plasma

  At baseline and after 24 hours of each ventilatory strategy during phase 3

Secondary Outcomes (4)

• (Second Phase) Respiratory Mechanics Variables

  Two hours on each ventilatory strategy during phase 2

• (Third Phase) Change in High-Magnitude Pendelluft

  At baseline and after 24 hours of each ventilatory strategy during phase 3

• (Third Phase) Change in Respiratory Mechanics Variables

  At baseline and after 24 hours of each ventilatory strategy during phase 3

• (Third Phase) Change in Neuromechanical Coupling of Diaphragm

  At baseline and after 24 hours of each ventilatory strategy during phase 3

Study Arms (3)

Control Group

SHAM COMPARATOR

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.

Procedure: Control

Prone Positioning

EXPERIMENTAL

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

Procedure: Prone Positioning

Thoracoabdominal Binding

EXPERIMENTAL

ARDS patients at spontaneous breathing onset on pressure support ventilation mode in supine position at 45º degrees using thoracoabdominal binding with the binder's upper edge above the costal margin, performed under standard PEEP according to ARDSNet strategy and individualized PEEP applied in random order.

Procedure: Thoracoabdominal Binding

Interventions

Prone Positioning PROCEDURE

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

Prone Positioning

Thoracoabdominal Binding PROCEDURE

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

Thoracoabdominal Binding

Control PROCEDURE

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.

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Chile: lead
• Fondo Nacional de Desarrollo Científico y Tecnológico, Chile: collaborator

Study Sites (1)

Hospital Clínico Universidad de Chile

Independencia, Chile

RECRUITING

MeSH Terms

Conditions

Respiratory Distress Syndrome

Interventions

Prone Position

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Intervention Hierarchy (Ancestors)

Posture; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Rodrigo Cornejo

  University of Chile

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rodrigo Cornejo

CONTACT

+56229788264; racornej@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

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

Study Record Dates

• First Submitted: March 6, 2023
• First Posted: April 24, 2023
• Study Start: December 6, 2023
• Primary Completion: March 1, 2026
• Study Completion: April 1, 2026
• Last Updated: January 2, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)