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

Not Applicable

Not yet recruiting

• Conditions: Acute Respiratory Distress Syndrom
• Interventions: Procedure: Selective lung recruitment

• Registration Number: NCT06609629
• Lead Sponsor: University Hospital, Caen

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-07
• Study First Submitted: 2024-07-18
• Study Start: 2024-09-15
• Study First Submitted QC: 2024-09-19
• Last Update Submitted: 2024-09-19
• Study First Posted: 2024-09-24
• Last Update Posted: 2024-09-24
• Primary Completion: 2025-09
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
interventional arm	Selective lung recruitment	This is a feasibility study. One arm of 10 patients is needed

Primary Outcome Measures

Name	Time	Method
comparison in lung aeration before and after the recruiting manouever	the sthe second CT will be perform between hour 4 and hour 8 after the maneuver (Hour 0).	Differance in lung aeration wil be assess with comparison between lung aeration on a chest CT-scan before the recruiting maneuver and lung aeration on a chest CT-scan after the recruitment maneuver. The principal outcome will be the ratio of normaly aerated lung volume (%)/hyperinflated lung volume (%). The higher this ratio will be the better is the recruitment (high volume recruited and low volume hyperinflated). The level of aeration of the lung will be determined using the density level on CT-scan where lung area will be classified among 4 category according a level of hounsfield unit (non aerated :density betwen +100 et -100 Hounsfield unit ; poorly aerated: density betwen -101 et -500 Hounsfield unit; normaly aerated: density betwen -501 et -900 Hounsfield unit; hyperinflated (density betwen -901 et -1000 Hounsfield unit). Each area will be quantified using AquariusTM software.

Secondary Outcome Measures

Name	Time	Method
difference between lung impedance before and after selective recruitment maneuvers	measured immedialtly before the recruitment maneuver (hour 0), between hour 4 to hour 8 after the recruitiment maneuver , at hour 24 after the selective recruitment maneuver	measure of lung impedance using an electrical impedance tomodensitometry device (pulmovista Dräger)
PaO2/FiO2 ratio	measured immedialtly before the recruitment maneuver (hour 0), between hour 4 to hour 8 after the recruitiment maneuver , at hour 24 after the selective recruitment maneuver