Selective Lung Recruitment in Moderate to Severe ARDS : a Pilot Study

NCT ID: NCT06609629

Last Updated: 2024-09-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-15
• Study Completion Date: 2025-09-30

Brief Summary

Acute respiratory distress syndrome (ARDS) is an acute condition affecting the lung after clinical aggression ( infectious process, pancreatitis, acute inflammatory event). This condition lead to major breathlessness due to the incapacity to properly oxygenize the boby because of lung lesions. Invasive mechanical ventilation is frequently required to grant sufficient oxygenation to the body. Unfortunately, while it allows oxygenation, mechanical ventilation can cause arms to the lung because of the mechanical power it delivers to the lung and create ventilation induced lung injuries (VILI). To reduce this risk, ventilator settings have been protocolized aiming to reduce the lung volume administered to the lung. It is effective to control the VILI but oxygenation may be insufficient under those protective parameters. To correct this lack of oxygenation practicians use recruiting maneuvers when a transient increase of lung volume administered to the lung to open collapse parts of the lung. Those maneuvers can cause barotrauma and provoke pneumothorax or decrease the heart flow. This study aim to assess the feasibility of selective recruitment maneuvers to increase oxygenation while reducing the risk of recruitment maneuvers.

Briefly, a dedicated bronchial blocker is introduce in a lower part of the lung, a balloon attached to the catheter is expended isolating a part of the lung and a recruiting pressure is administered through the lumen of the catheter to selectively expend the isolated part of the lung.

After the selected recruitment maneuver, the investigators will assess the expansion of the lung with a CT-scanner.

Conditions

Acute Respiratory Distress Syndrom

Study Design

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

Study Groups

interventional arm

This is a feasibility study. One arm of 10 patients is needed

Group Type: EXPERIMENTAL

Selective lung recruitment

Intervention Type: PROCEDURE

A bronchial blocker with a lumen is inserted in one inferior pulmonary lobe using a fibroscope. The baloon of the blocker is expended to isolate the lobe. A second ventilator is used to apply a pressure of 45cmH2o through the lumen of the blocker. The recruiting pressure is maintained 30 to 60 second. After the procedure, the blocker is removed and the procedure is repeated in the controlateral inferior lobe.

Interventions

Selective lung recruitment

A bronchial blocker with a lumen is inserted in one inferior pulmonary lobe using a fibroscope. The baloon of the blocker is expended to isolate the lobe. A second ventilator is used to apply a pressure of 45cmH2o through the lumen of the blocker. The recruiting pressure is maintained 30 to 60 second. After the procedure, the blocker is removed and the procedure is repeated in the controlateral inferior lobe.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• acute ARDS according Berlin definition and a PaO2/FiO2 ratio inferior to 200
• patient under sedation and muscular blockade
• postero-basal consolidation on CT or pulmonary ultrasound
• affiliated to the French social insurance system

Exclusion Criteria

• hemodynamic instability
• pregnancy
• patient under guardianship

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

Sponsors

University Hospital, Caen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Pierre Cuchet, MD

Role: CONTACT

cuchet-p@chu-caen.fr

33231064716

Other Identifiers

2024-A00005-42

Identifier Type: -

Identifier Source: org_study_id