Ventilatory Strategy Based on Ultrasound Lung Morphology in Patients With Focal ARDS (LUVS)
Primary Purpose
Focal Acute Respiratory Distress Syndrome
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
LUVS" ventilatory strategy composed of a bundle of measures
Ventilatory management according to international recommendations (Société de Réanimation de la Langue Française)
Sponsored by
About this trial
This is an interventional other trial for Focal Acute Respiratory Distress Syndrome
Eligibility Criteria
Inclusion Criteria:
- person who has given oral consent or has been included in an emergency
- Older than 18 years
- On mechanical ventilation for less than 24 hours
- Diagnosis of ARDS for less than 24 hours. ARDS according to the Berlin classification: i.e. arterial oxygen pressure to inspired oxygen fraction ratio less than or equal to 300, with a PEEP greater than or equal to 5, presence of bilateral radiological infiltrates not fully explained by heart failure or volume overload
- Focal ARDS determined on pulmonary ultrasound
Exclusion Criteria:
- person who is not a beneficiary of national health insurance
- person who is subject to a legal measure of protection (curatorship, guardianship)
- pregnant or breastfeeding women
- minor
- Patient having benefited from an invasive mechanical ventilation of more than one week in the previous month;
- ARDS in the previous month;
- Chronic respiratory failure under NIV or long term oxygen;
- Severe acute asthma;
- Lobectomy;
- Pneumothorax;
- Pneumomediastinum;
- Pulmonary fibrosis;
- Morbid obesity with a BMI above 40 ;
- Cancer with metastasis;
- Bone marrow transplantation;
- Chemotherapy-induced neutropenia;
- Cirrhosis with a Child-Pugh score of C;
- Suspected or confirmed intracranial hypertension;
- Concurrent participation in another ARDS study;
- Extensive burns on the torso.
Sites / Locations
- Chu Dijon BourgogneRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
interventional
control
Arm Description
Outcomes
Primary Outcome Measures
Number of days without invasive ventilation
Secondary Outcome Measures
Full Information
NCT ID
NCT04966624
First Posted
July 8, 2021
Last Updated
November 25, 2021
Sponsor
Centre Hospitalier Universitaire Dijon
1. Study Identification
Unique Protocol Identification Number
NCT04966624
Brief Title
Ventilatory Strategy Based on Ultrasound Lung Morphology in Patients With Focal ARDS
Acronym
LUVS
Official Title
Ventilatory Strategy Based on Ultrasound Lung Morphology in Patients With Focal ARDS
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
October 13, 2021 (Actual)
Primary Completion Date
January 2026 (Anticipated)
Study Completion Date
January 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire Dijon
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
ARDS is characterized by a diffuse, bilateral, extensive alveolar-interstitial infiltrate related to damage to the alveolar membrane.
Studies of lung morphology assessed by CT scan have shown 2 types of ARDS. When the loss of ventilation is posterior and caudal, and the pulmonary parenchyma is otherwise "healthy", ARDS is said to be focal. When the loss of ventilation is diffuse, associated with excess tissue affecting the entire lung parenchyma, ARDS is said to be non-focal or diffuse.
Only one recent multicenter study has evaluated whether individualized PEEP adjustment according to lung morphology (focal vs. non-focal) could improve ARDS survival outcomes compared with standard of care. Results for the primary endpoint, 90-day mortality, were negative. But lung morphology was misclassified on CT occurred 85 (21%) of 400 patients. In addition, per-protocol analysis in which misclassified patients were excluded showed that mortality was significantly lower in the personalized ventilation group than in the control group.
Lung ultrasound may be the ideal bedside imaging technique. The loss of pulmonary aeration and its variations induced by therapeutic maneuvers can be quantified by lung ultrasound. Lung ultrasound is a non-invasive, non-ionizing radiation method that can be easily used at the bedside.
APRV ventilation coupled with spontaneous breathing activity prevents atelectasis formation, recruits less ventilated areas, prevents mechanical ventilation-induced lung injury and improves lung compliance.
The hypothesis is that a "LUVS" ventilatory strategy composed of a bundle of measures all aiming at reopening the atelectatic pulmonary zones in focal ARDS (synergistic effect of spontaneous ventilation in APRV mode, early prone sessions, and adjustment of PEEP according to the patient's BMI), could decrease the number of days under mechanical ventilation, compared to protective ventilation with low tidal volume according to the current international recommendations
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Focal Acute Respiratory Distress Syndrome
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
84 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
interventional
Arm Type
Experimental
Arm Title
control
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
LUVS" ventilatory strategy composed of a bundle of measures
Intervention Description
Ventilation in APRV mode early prone sessions, adjustment of positive expiratory pressure according to the patient's BMI and no curarization
Intervention Type
Procedure
Intervention Name(s)
Ventilatory management according to international recommendations (Société de Réanimation de la Langue Française)
Intervention Description
Ventilatory management according to international recommendations (Société de Réanimation de la Langue Française)
Primary Outcome Measure Information:
Title
Number of days without invasive ventilation
Time Frame
28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
person who has given oral consent or has been included in an emergency
Older than 18 years
On mechanical ventilation for less than 24 hours
Diagnosis of ARDS for less than 24 hours. ARDS according to the Berlin classification: i.e. arterial oxygen pressure to inspired oxygen fraction ratio less than or equal to 300, with a PEEP greater than or equal to 5, presence of bilateral radiological infiltrates not fully explained by heart failure or volume overload
Focal ARDS determined on pulmonary ultrasound
Exclusion Criteria:
person who is not a beneficiary of national health insurance
person who is subject to a legal measure of protection (curatorship, guardianship)
pregnant or breastfeeding women
minor
Patient having benefited from an invasive mechanical ventilation of more than one week in the previous month;
ARDS in the previous month;
Chronic respiratory failure under NIV or long term oxygen;
Severe acute asthma;
Lobectomy;
Pneumothorax;
Pneumomediastinum;
Pulmonary fibrosis;
Morbid obesity with a BMI above 40 ;
Cancer with metastasis;
Bone marrow transplantation;
Chemotherapy-induced neutropenia;
Cirrhosis with a Child-Pugh score of C;
Suspected or confirmed intracranial hypertension;
Concurrent participation in another ARDS study;
Extensive burns on the torso.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
BOUHEMAD Belaid
Phone
03 80 29 30 79
Email
belaid.bouhemad@chu-dijon.fr
Facility Information:
Facility Name
Chu Dijon Bourgogne
City
Dijon
ZIP/Postal Code
21000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ABAGRI Sohel
Email
sohel.abagri@chu-dijon.fr
12. IPD Sharing Statement
Learn more about this trial
Ventilatory Strategy Based on Ultrasound Lung Morphology in Patients With Focal ARDS
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