Clinical trial NCT06609629: Selective Lung Recruitment in Moderate to Severe ARDS : a Pilot Study
Official title: Selective Lung Recruitment in Moderate to Severe ARDS : a Pilot Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Acute Respiratory Distress Syndrom
Keywords: ARDS
Recruitment maneuvers
selective recruitment maneuvers
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2024-09-24
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: comparison in lung aeration before and after the recruiting manouever
timeFrame: the sthe second CT will be perform between hour 4 and hour 8 after the maneuver (Hour 0).
Secondary outcomes:
measure: difference between lung impedance before and after selective recruitment maneuvers
timeFrame: 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: PaO2/FiO2 ratio
timeFrame: 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
Other outcomes:
measure: Occurence of pneumothorax
timeFrame: the second ct-scan will be perform between hour 4 and hour 8 after the recruitment maneuver (hour O). A chest-x-ray wil be perform at hour 24.
measure: occurence of cardiac arrest
timeFrame: from enrollment to the end of treatment (from Hour 0 to Hour 24 after the recruiting maneuver)
measure: decrease in blood pressure
timeFrame: from the expension of the catheter ballon at the begining of the recruitment maneuvrer to the deflation of the catheter ballon at the end of the maneuver.
measure: decrease in peripheral O2 saturation
timeFrame: from the expension of the catheter ballon at the begining of the recruitment maneuvrer to the deflation of the catheter ballon at the end of the maneuver.
Locations:
Study officials:
References: