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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Acute Respiratory Distress Syndrom
• Intervention / Treatment: Procedure: Selective lung recruitment

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pierre Cuchet, MD; Phone Number: 33231064716; Email: cuchet-p@chu-caen.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: interventional arm; This is a feasibility study. One arm of 10 patients is needed

Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
comparison in lung aeration before and after the recruiting manouever	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.	the sthe second CT will be perform between hour 4 and hour 8 after the maneuver (Hour 0).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
difference between lung impedance before and after selective recruitment maneuvers	measure of lung impedance using an electrical impedance tomodensitometry device (pulmovista Dräger)	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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurence of pneumothorax	presence of pneumothorax on the second chest CT presence of pneumothorax on chest x-ray	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.
occurence of cardiac arrest	occurence of cardiac arrest is defined has the need of perfoming a cardio-pulmonary resuscitation	from enrollment to the end of treatment (from Hour 0 to Hour 24 after the recruiting maneuver)
decrease in blood pressure	defined as a drop of 20mmHg of arterial systolic pressure	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.
decrease in peripheral O2 saturation	mesured with a transcutaneous saturometer.	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.

Collaborators and Investigators

• Sponsor: University Hospital, Caen

Study record dates

Study Major Dates

• Study Start (Estimated): September 15, 2024
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: July 18, 2024
• First Submitted That Met QC Criteria: September 19, 2024
• First Posted (Actual): September 24, 2024

Study Record Updates

• Last Update Posted (Actual): September 24, 2024
• Last Update Submitted That Met QC Criteria: September 19, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: ARDS; Recruitment maneuvers; selective recruitment maneuvers
• Other Study ID Numbers: 2024-A00005-42

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No