search
Back to results

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

Primary Purpose

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

Status
Recruiting
Phase
Not Applicable
Locations
Chile
Study Type
Interventional
Intervention
Prone Positioning
Abdominal Binding
Control
Sponsored by
University of Chile
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Acute Respiratory Distress Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Clínico Universidad de ChileRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Sham Comparator

Experimental

Experimental

Arm Label

Control Group

Prone Positioning

Abdominal Binding

Arm Description

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

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

ARDS patients at spontaneous breathing onset on pressure control partial assisted ventilation in supine position at 45º degrees using an abdominal binder with the binder's upper edge below the costal margin to allow rib-cage movement, performed under standard PEEP according to ARDSNet strategy and individualized PEEP applied in random order.

Outcomes

Primary Outcome Measures

(Second Phase) High-Magnitude Pendelluft
Frequency 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)
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
(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
(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

Secondary Outcome Measures

(Second Phase) Respiratory Mechanics Variables
Esophageal pressure swing, transdiaphragmatic pressure and transpulmonary driving pressure measured by a esophageal/gastric catheter
(Third Phase) Change in High-Magnitude Pendelluft
Frequency of high-magnitude pendelluft monitored by electrical impedance tomography
(Third Phase) Change in Respiratory Mechanics Variables
Esophageal pressure swing, transdiaphragmatic pressure and transpulmonary driving pressure measured by a esophageal/gastric catheter
(Third Phase) Change in Neuromechanical Coupling of Diaphragm
Change 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

Full Information

First Posted
March 6, 2023
Last Updated
May 2, 2023
Sponsor
University of Chile
Collaborators
Fondo Nacional de Desarrollo Científico y Tecnológico, Chile
search

1. Study Identification

Unique Protocol Identification Number
NCT05826847
Brief Title
Prone Positioning and Abdominal Binding on Lung and Muscle Protection in ARDS Patients During Spontaneous Breathing
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 2023 (Anticipated)
Primary Completion Date
March 2026 (Anticipated)
Study Completion Date
April 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Chile
Collaborators
Fondo Nacional de Desarrollo Científico y Tecnológico, Chile

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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 abdominal 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 PHASE: A multimodal physiological description will be performed in assist-control ventilation at spontaneous breathing onset. At the study entry, 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 PHASE: After the multimodal physiological description, a controlled randomized crossover trial will assign patients to three strategies of 2-hours period on assisted pressure-controlled ventilation mode: A.- Control group: supine at 45º, B.- Abdominal binding: supine at 45º plus abdominal binding, C.- Prone positioning (without abdominal banding). 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 PHASE: The day next to the crossover trial, each patient will be randomized to one of the three ventilatory strategies previously defined, A.- Control group: supine at 45º, B.- Abdominal 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 assisted pressure-controlled ventilation mode receiving an individualized PEEP level.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Distress Syndrome, Mechanical Ventilation Complication, ICU Acquired Weakness

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Three phase-study: Multimodal physiological description Randomized crossover trial Pilot randomized trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
Sham Comparator
Arm Description
ARDS patients at spontaneous breathing onset on pressure control partial assisted ventilation in supine position at 45º degrees, performed under standard PEEP according to ARDSNet strategy and individualized PEEP applied in random order.
Arm Title
Prone Positioning
Arm Type
Experimental
Arm Description
ARDS patients at spontaneous breathing onset on pressure control partial assisted ventilation in prone position, performed under standard PEEP according to ARDSNet strategy and individualized PEEP applied in random order.
Arm Title
Abdominal Binding
Arm Type
Experimental
Arm Description
ARDS patients at spontaneous breathing onset on pressure control partial assisted ventilation in supine position at 45º degrees using an abdominal binder with the binder's upper edge below the costal margin to allow rib-cage movement, performed under standard PEEP according to ARDSNet strategy and individualized PEEP applied in random order.
Intervention Type
Procedure
Intervention Name(s)
Prone Positioning
Intervention Description
Prone positioning will be performed according to ICU local protocol with trained provider teams.
Intervention Type
Procedure
Intervention Name(s)
Abdominal Binding
Intervention Description
An abdominal binder will be used in semi-recumbent position (supine at 45º). The degree of abdominal compression will be defined as an increase in end-expiration gastric pressure of 5 cm of water during steady-state breathing; this level of abdominal compression has demonstrated to optimize lung function and neuromuscular efficiency in healthy subjects and athletes with cervical spinal cord injury.
Intervention Type
Procedure
Intervention Name(s)
Control
Intervention Description
ARDS patients at spontaneous breathing onset on pressure control partial assisted ventilation in supine position at 45º degrees, performed under standard PEEP according to ARDSNet strategy and individualized PEEP applied in random order.
Primary Outcome Measure Information:
Title
(Second Phase) High-Magnitude Pendelluft
Description
Frequency of high-magnitude pendelluft monitored by electrical impedance tomography
Time Frame
Two hours on each ventilatory strategy during phase 2 (day 2 of the protocol)
Title
(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)
Description
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
Time Frame
At baseline and after 24 hours of each ventilatory strategy during phase 3 (day 3 of the protocol)
Title
(Third Phase) Change in Regional Lung Inflammation
Description
Regional lung inflammation will be evaluated with dynamic positron emission tomography/computed tomography of fluoro-2-deoxy-D-glucose (18F-FDG) net uptake rate
Time Frame
At baseline and after 24 hours of each ventilatory strategy during phase 3 (day 3 of the protocol)
Title
(Third Phase) Change in Fast-Twitch Skeletal Muscle Troponin I Measured by ELISA
Description
ELISA-based detection of fast-twitch skeletal muscle troponin I measured in plasma
Time Frame
At baseline and after 24 hours of each ventilatory strategy during phase 3 (day 3 of the protocol)
Secondary Outcome Measure Information:
Title
(Second Phase) Respiratory Mechanics Variables
Description
Esophageal pressure swing, transdiaphragmatic pressure and transpulmonary driving pressure measured by a esophageal/gastric catheter
Time Frame
Two hours on each ventilatory strategy during phase 2 (day 2 of the protocol)
Title
(Third Phase) Change in High-Magnitude Pendelluft
Description
Frequency of high-magnitude pendelluft monitored by electrical impedance tomography
Time Frame
At baseline and after 24 hours of each ventilatory strategy during phase 3 (day 3 of the protocol)
Title
(Third Phase) Change in Respiratory Mechanics Variables
Description
Esophageal pressure swing, transdiaphragmatic pressure and transpulmonary driving pressure measured by a esophageal/gastric catheter
Time Frame
At baseline and after 24 hours of each ventilatory strategy during phase 3 (day 3 of the protocol)
Title
(Third Phase) Change in Neuromechanical Coupling of Diaphragm
Description
Change 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
Time Frame
At baseline and after 24 hours of each ventilatory strategy during phase 3 (day 3 of the protocol)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rodrigo Cornejo
Phone
+56229788264
Email
racornej@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rodrigo Cornejo
Organizational Affiliation
University of Chile
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Clínico Universidad de Chile
City
Independencia
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rodrigo Cornejo
Phone
+56229788264
Email
racornej@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs