Clinical trial NCT05876468: Effects of Continuous Anterior Chest Compression
Official title: " Effects of Continuous Anterior Chest Compression (CACC) & Comparision With Prone Position in ARDS Patients " The StrapVent Study "
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Evaluable
Keywords: ARDS : Acute Respiratory Distress Syndrome
CACC : Continuous Anterior Chest Compression
VILI : Ventilator-Induced Lung Injury
ARDS,Human: Adult Respiratory Distress Syndrome
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2023-05-25
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Clinical trials with a single arm
Primary purpose: BASIC_SCIENCE

Brief summary: The aim is to test the physiological effects of continuous anterior chest compression in patients with severe to moderate ARDS.

Detailed description: Acute respiratory distress syndrome (ARDS) is usually characterized by inhomogeneous lesions, leading to an inhomogeneous distribution of the mechanical ventilation with the following several deleterious effects: atelectrauma of dependent posterior areas and overdistension in the anterior ones. Therefore, the gold standard treatment is to prevent VILI with lung protective ventilation : low tidal volume, high positive end expiratory pressure and prone positioning which is a technique that reduces mortality. Prone positioning has several beneficial effects : it relieves cardiac compression of the supporting lung, it stiffens the anterior chest wall thus limiting the risk of overdistension of anterior areas and promotes recruitment of non-dependent posterior pulmonary units. The overall effect is a more uniform distribution of transpulmonary pressures and improved ventilation to perfusion ratios.

Similar to prone positioning, continuous anterior chest wall compression stiffens the anterior chest wall. The investigators hypothesize that such reduction in anterior chest wall compliance may protect against overdistension and promote the redistribution of the ventilation in posterior areas.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 ans
* Intubated moderate and severe ARDS according to the Berlin definition (PaO2/FiO2 ratio \<= 200 mmHg)
* The patent must be sedated and paralyzed
* Informed consent from patient or family members

Exclusion Criteria:

* Extracorporeal membrane oxygenation (ECMO)
* Pneumothorax
* Thoracic trauma during the last 3 months
* Refractory shock
* Contraindication to EIT monitoring (e.g. burns, pacemaker, thoracic wounds limiting electrode belt placement)
* Pregnancy
* Any contra-indication to esophageal manometry (less than one month esophagus surgery, bronchopleural or esotracheal fistula, latex allergy)
* No social care
* Adults under Guardianship, curatorship or protection of the court

Primary outcomes:
measure: The end inspiratory transpulmonary pressure (PL-insp) in centimetre of water
timeFrame: Through study completion (up to 6 hours)
Secondary outcomes:
measure: Regional pulmonary compliances in centimetre of water
timeFrame: Through study completion (up to 6 hours)
measure: Lung mechanics : Airways pressure, Flow curves and Esophageal pressure
timeFrame: Through study completion (up to 6 hours)
measure: Pulmonary ventilation distribution in percentage
timeFrame: Through study completion (up to 6 hours)
measure: Recruitment-to-inflation (R/I) ratio
timeFrame: Through study completion (up to 6 hours)
measure: Hemodynamics
timeFrame: Through study completion (up to 6 hours)
measure: Arterial blood gazes (ABG
timeFrame: Through study completion (up to 6 hours)
measure: Incidence of CACC adverse events
timeFrame: Through study completion (up to 6 hours)
measure: End expiratory lung impedance (EELZ) expressed in arbitrary units
timeFrame: Through study completion (up to 6 hours) ]
Other outcomes:
Locations:
city: Créteil
country: France
facility: Assistance Publique Hôpitaux de Paris - CHU HENRI MONDOR
Study officials:
affiliation: APHP
name: Guillaume CARTEAUX, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: