Safety of Low PEEP Maneuvers During ARDS Management (DEBAS)

Acute Respiratory distress syndrome (ARDS) is a severe condition in which protective ventilation is a critical point in its management. Positive end expiratory pressure (PEEP) setting can be challenging for clinicians and high PEEP has been associated with better outcome in moderate and severe ARDS. Recently, recruitment to inflation ratio and airway closure have been investigated in order to help PEEP adjustment. However, ventilatory maneuvers are performed with a low level of PEEP and therefore expose to derecruitment and oxygen desaturation. So far, the risk of oxygen desaturation has not been investigated and risk factors are unknown.

The aim of this study is to evaluate the prevalence of oxygen desaturation during ventilatory maneuvers at low level of PEEP in patients with moderate or severe ARDS

Study Overview

• Status: Recruiting
• Conditions: Acute Respiratory Distress Syndrome; Positive End Expiratory Pressure

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Yoann Zerbib, MD; Phone Number: 03 22 08 77 23; Email: zerbib.yoann@chu-amiens.fr

Study Locations

• France
  • Amiens, France, 80480
    • Recruiting
    • CHU Amiens
    • Contact: Yoann Zerbib, MD; Phone Number: 03 22 08 77 23; Email: zerbib.yoann@chu-amiens.fr
    • Contact: Yoann Zerbib; Phone Number: 03 22 08 77 23; Email: zerbib.yoann@chu-amiens.fr

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

PEEP in patients with moderate or severe ARDS

Description

Inclusion Criteria:

• age : > 18 yo
• inclusion criteria: ARDS, Mechanical ventilation, low PEEP maneuvers

Exclusion Criteria:

• refusal to participate

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
prevalence of oxygen desaturation	24 months

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire, Amiens
• Collaborators: Centre Hospitalier VALENCIENNES

Study record dates

Study Major Dates

• Study Start (Actual): May 28, 2022
• Primary Completion (Estimated): November 1, 2024
• Study Completion (Estimated): November 1, 2024

Study Registration Dates

• First Submitted: June 20, 2023
• First Submitted That Met QC Criteria: June 20, 2023
• First Posted (Actual): June 28, 2023

Study Record Updates

• Last Update Posted (Actual): July 10, 2024
• Last Update Submitted That Met QC Criteria: July 9, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Positive end expiratory pressure; Acute Respiratory distress syndrome
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Infant, Newborn, Diseases; Lung Injury; Infant, Premature, Diseases; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
• Other Study ID Numbers: PI2021_843_0165

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