Effects of Continuous Anterior Chest Compression

NCT ID: NCT05876468

Last Updated: 2023-05-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-01
• Study Completion Date: 2024-06-28

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.

Conditions

Evaluable

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

A description of each arm of the clinical trial that indicates its role in the clinical trial

Arm 1 Description:

The study will consitent of recording the measurments of ventilatory settings, respiratory mechanics, flow and pressure curves, gaz exchange, haemodynamics and ventilation distribution in 5 consecutive conditions in adult patients with moderate to severe ARDS :

• After 16 hours of prone position
• In supine position 1 hour after the prone position
• 15mn after CACC with a pressure equal to the one observed in the prone position
• 15mn after CACC with a pressure set at 60 - 80 cmH20
• 15mn after taking of the CACC

Group Type: EXPERIMENTAL

Continuous anterior chest compression

Intervention Type: DEVICE

Patients with severe to moderate ARDS who were placed in prone position by the attending physician :

• First CACC : the applied pressure is equal to the one observed in the prone position
• Second CACC : The applied pressure is set at 60 - 80 cmH20

Interventions

Continuous anterior chest compression

Patients with severe to moderate ARDS who were placed in prone position by the attending physician :

• First CACC : the applied pressure is equal to the one observed in the prone position
• Second CACC : The applied pressure is set at 60 - 80 cmH20

Intervention Type: DEVICE

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

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

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Guillaume CARTEAUX, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

APHP

Locations

Assistance Publique Hôpitaux de Paris - CHU HENRI MONDOR

Créteil, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Guillaume CARTEAUX, MD, PhD

Role: CONTACT

guillaume.carteaux@aphp.fr

(+33) 01 45 17 86 38

Other Identifiers

APHP 211357

Identifier Type: -

Identifier Source: org_study_id