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

NCT ID: NCT05826847

Last Updated: 2024-01-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-06
• Study Completion Date: 2026-04-30

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Control Group

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.

Group Type: SHAM_COMPARATOR

Control

Intervention Type: 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.

Prone Positioning

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.

Group Type: EXPERIMENTAL

Prone Positioning

Intervention Type: PROCEDURE

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

Thoracoabdominal Binding

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.

Group Type: EXPERIMENTAL

Thoracoabdominal Binding

Intervention Type: 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

Interventions

Prone Positioning

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

Intervention Type: 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

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondo Nacional de Desarrollo Científico y Tecnológico, Chile

OTHER_GOV

Sponsor Role: collaborator

University of Chile

OTHER

Sponsor Role: lead

Responsible Party

Rodrigo Cornejo

Full Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rodrigo Cornejo

Role: PRINCIPAL_INVESTIGATOR

University of Chile

Locations

Hospital Clínico Universidad de Chile

Independencia, , Chile

Site Status: RECRUITING

Countries

Chile

Central Contacts

Rodrigo Cornejo

Role: CONTACT

racornej@gmail.com

+56229788264

Facility Contacts

Rodrigo Cornejo

Role: primary

racornej@gmail.com

+56229788264

Other Identifiers

1221829

Identifier Type: -

Identifier Source: org_study_id