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Clinical Trials/NCT06609629
NCT06609629
Not yet recruiting
Not Applicable

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

University Hospital, Caen0 sites10 target enrollmentSeptember 15, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Acute Respiratory Distress Syndrom
Sponsor
University Hospital, Caen
Enrollment
10
Primary Endpoint
comparison in lung aeration before and after the recruiting manouever
Status
Not yet recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 15, 2024
End Date
September 2025
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

comparison in lung aeration before and after the recruiting manouever

Time Frame: 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 Outcomes

  • 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)
  • 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)

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