WeanINg From Mechanical Ventilation for ARDS CovId-19 Patients Guided by Combined Thoracic UltraSound.

NCT04372680 | Completed

• 2 other identifiers: RC31/20/01382020-A00916-33
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 2

Brief Summary

The most feared complication of COVID-19 infection is the occurrence of an acute respiratory distress syndrome (ARDS) that requires ICU admission and prolonged mechanical ventilation in more than 2% of the affected patients. Establishing the correct time to extubate mechanically ventilated patients is a crucial issue in the critical care practice. Delayed extubation has several consequences such as patient's mortality, health-care-related complications, neuropsychological adverse events. The aim of the INVICTUS study is to evaluate whether a CTUS-based MV weaning strategy could reduce the duration of mechanical ventilation of ARDS COVID-19 ICU patients by 72 hours, compared with usual medical care.

Conditions

COVID-19; ARDS, Human; Mechanical Ventilation

Keywords

COVID-19,; ARDS; Mechanical ventilation; Lung ultrasound; Echocardiography

Outcome Measures

Primary Outcomes (1)

• Delay from the start of Mechanical Ventilation weaning process to extubation

  Delay from the start of MV weaning process (day of the switch from volume control mode to pressure support ventilation) to extubation (or spontaneously breathing through tracheostomy cannula) for at least 48 hours, as previously defined.

  day 28

Secondary Outcomes (3)

• delay from intubation to extubation

  day 28

• Successful of extubation

  day 28

• mortality rate

  day 28

Study Arms (2)

CTUS strategy group

EXPERIMENTAL

CTUS examination will be performed until the day of patient extubation. CTUS examination will consist on a fully bedside ultrasonographic assessment of lung, cardiac and diaphragm functions

Diagnostic Test: CTUS examination

standard strategy group

NO INTERVENTION

from the day of patient's inclusion and beyond every day, the clinical team in charge of patients will decide to perform or not an SBT following current recommendations2. These criteria are mainly based on clinical data and do not include any specific ultrasound assessment.

Interventions

CTUS examination DIAGNOSTIC_TEST

fully bedside ultrasonographic assessment of lung, cardiac and diaphragm functions

CTUS strategy group

Eligibility Criteria

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

You may qualify if:

• ICU admission for severe acute respiratory distress syndrome (ARDS, as previously defined5 by a ratio of the partial pressure of arterial oxygen to the fraction of inspired oxygen of less than 150) related to COVID-19.
• Non paralyzed because of neuromuscular blocking agents.
• Ventilated patient in pressure support mode for at least 6 hours and at most 24 hours.
• Surrogate decision maker's consent.
• Affiliated person or beneficiary of a social security scheme.

You may not qualify if:

• Reduction or cessation of active treatment.
• Paraplegia with medullar level more than T8.
• Tracheostomy before hospital admission.
• History of severe respiratory illness.
• Patient under juridical protection.
• Pregnancy or nursing woman.
• Enrolled in another trial evaluating mechanical ventilation.

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (2)

CHU de LIMOGES

Limoges, France

Location

CHU de TOULOUSE

Toulouse, 31000, France

Location

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

• Béatrice RIU-POULENC

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multicenter, Randomized, Controlled, open-label, in parallel group

Study Record Dates

• First Submitted: April 30, 2020
• First Posted: May 4, 2020
• Study Start: April 22, 2020
• Primary Completion: April 1, 2022
• Study Completion: April 1, 2022
• Last Updated: October 17, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)