Transpulmonary Driving Pressure in ARDS COVID19 Patients

NCT04381286 | Unknown

• 1 other identifier: RECHMPL20_0194
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

A majority (65-85%) of critically ill patients admitted in intensive care units with a confirmed diagnostic of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) developed an acute respiratory distress syndrome (ARDS) according to BERLIN criteria. Gattinoni et al. recently described that the ARDS related to SARS-CoV-2 was not a "Typical" ARDS. Patients affected by this infection present indeed a major hypoxemia, which was surprisingly associated in early phase with a high compliance of respiratory system, more than 50 ml/cm H2O in most cases. The cornerstone of current treatment in case of ARDS is the use of "lung protective" ventilation, including limited tidal volumes (VT), low end-inspiratory plateau pressures while maintaining sufficiently-high positive end-expiratory pressures (PEEP). However, high levels of PEEP in patients may have detrimental effects on hemodynamic status and fluid retention, particularly when the respiratory system compliance is normal. High PEEP may also lead to overdistension and an increase of alveolar dead space. The airway pressures commonly monitored does not reliably reflect the impact of pressures on the lung parenchyma. Elastance of chest wall may indeed largely influence values of airways pressions. In contrast, transpulmonary pressure obtained using esophageal pressure (Pes) directly reflect lung overdistension risk and lung properties. In order to better understand this new kind of ARDS characterized by modest recruitable profile and to better personalize mechanical ventilation setting and therapy it is obvious to precise transpulmonary pressure.

Conditions

Mechanical Ventilation; SARS-CoV-2; COVID-19

Keywords

elastance; Acute respiratory distress syndrome; Esophageal pressure; Pleural pressure

Outcome Measures

Primary Outcomes (1)

• Duration of mechanical Ventilation

  Duration of mechanical Ventilation

  1 day

Secondary Outcomes (5)

• Number of Participants with during of Acute respiratory distress syndrom (SDRA)

  1 day

• Length of stay in intensive care unit

  1 day

• Mortality

  1 day

• number of patients with pulmonary complications

  1 day

• Number of Participants with pulmonary stress and strain

  1 day

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patient with SARS-CoV-2 and mechanical ventilation requirement

You may qualify if:

• Major patients (18-90 years old)
• Hospitalized following SARS-CoV-2
• Mechanical ventilatory support

You may not qualify if:

• Minor patients

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

RECRUITING

MeSH Terms

Conditions

COVID-19; Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• Ramin Séverin, MD

  University Hospital, Montpellier

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ramin Séverin, MD

CONTACT

46733825; s-ramin@chu-montpellier.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2020
• First Posted: May 8, 2020
• Study Start: April 1, 2019
• Primary Completion: April 1, 2021
• Study Completion: December 31, 2021
• Last Updated: May 12, 2020

Record last verified: 2020-04

Locations

FR (1)