- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05826847
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
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Rodrigo Cornejo
- Phone Number: +56229788264
- Email: racornej@gmail.com
Study Locations
-
-
-
Independencia, Chile
- Recruiting
- Hospital Clínico Universidad de Chile
-
Contact:
- Rodrigo Cornejo
- Phone Number: +56229788264
- Email: racornej@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Sham Comparator: 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.
|
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.
|
Experimental: 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.
|
Prone positioning will be performed according to ICU local protocol with trained provider teams.
|
Experimental: 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.
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
(Second Phase) High-Magnitude Pendelluft
Time Frame: Two hours on each ventilatory strategy during phase 2
|
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)
Time Frame: At baseline and after 24 hours of each ventilatory strategy during phase 3
|
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
Time Frame: At baseline and after 24 hours of each ventilatory strategy during phase 3
|
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
Time Frame: At baseline and after 24 hours of each ventilatory strategy during phase 3
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
(Second Phase) Respiratory Mechanics Variables
Time Frame: Two hours on each ventilatory strategy during phase 2
|
Esophageal pressure swing, transdiaphragmatic pressure and transpulmonary driving pressure measured by a esophageal/gastric catheter
|
Two hours on each ventilatory strategy during phase 2
|
(Third Phase) Change in High-Magnitude Pendelluft
Time Frame: At baseline and after 24 hours of each ventilatory strategy during phase 3
|
Frequency of high-magnitude pendelluft monitored by electrical impedance tomography
|
At baseline and after 24 hours of each ventilatory strategy during phase 3
|
(Third Phase) Change in Respiratory Mechanics Variables
Time Frame: At baseline and after 24 hours of each ventilatory strategy during phase 3
|
Esophageal pressure swing, transdiaphragmatic pressure and transpulmonary driving pressure measured by a esophageal/gastric catheter
|
At baseline and after 24 hours of each ventilatory strategy during phase 3
|
(Third Phase) Change in Neuromechanical Coupling of Diaphragm
Time Frame: At baseline and after 24 hours of each ventilatory strategy during phase 3
|
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
|
At baseline and after 24 hours of each ventilatory strategy during phase 3
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Rodrigo Cornejo, University of Chile
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1221829
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Acute Respiratory Distress Syndrome
-
Tanta UniversityRecruitingAcute Lung Injury/Acute Respiratory Distress Syndrome (ARDS) | Respiratory Distress Syndrome, PediatricEgypt
-
University Hospital, Clermont-FerrandWithdrawn
-
China-Japan Friendship HospitalNot yet recruitingAcute Lung Injury/Acute Respiratory Distress Syndrome (ARDS)
-
Dr. Behcet Uz Children's HospitalRecruitingAcute Respiratory Distress Syndrome | Acute Respiratory Failure | Pediatric Acute Respiratory Distress Syndrome (PARDS)Turkey
-
Assistance Publique - Hôpitaux de ParisCompletedSevere Acute Respiratory Syndrome Coronavirus 2 | Severe Acute Respiratory Distress SyndromeFrance
-
Aqualung Therapeutics Corp.Not yet recruitingAcute Respiratory Distress Syndrome (ARDS)
-
Unity Health TorontoRecruitingAcute Respiratory Distress Syndrome (ARDS)Canada, Spain, Italy, Brazil
-
Western University, CanadaEnrolling by invitationCOVID-19 Acute Respiratory Distress SyndromeCanada
-
Ain Shams UniversityCompletedCOVID-19 Acute Respiratory Distress SyndromeEgypt
-
Hospices Civils de LyonTerminatedAcute Respiratory Distress Syndrome (ARDS)France
Clinical Trials on Prone Positioning
-
Ayub Medical College, AbbottabadAyub Teaching HospitalCompletedCOVID-19 Pneumonia | COVID-19 Acute Respiratory Distress Syndrome | Prone PositioningPakistan
-
Johns Hopkins UniversityWest Penn Allegheny Health SystemRecruiting
-
Poudre Valley Health SystemRecruiting
-
University of Lausanne HospitalsCompletedARDS | Sars-CoV-2 InfectionSwitzerland
-
Centre Hospitalier Bretagne AtlantiqueCompletedARDS | Prone PositioningFrance
-
Dhritiman ChakrabartiCompleted
-
Policlinico HospitalCompleted
-
National Institute of Nursing Research (NINR)National Institutes of Health (NIH)Completed
-
Istanbul University - Cerrahpasa (IUC)RecruitingRespiratory Failure | Acute Respiratory Distress Syndrome | Ventilation Perfusion MismatchTurkey
-
University of Milano BicoccaCompleted