NCT04372680

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

WeanINg From Mechanical Ventilation for ARDS CovId-19 Patients Guided by Combined Thoracic UltraSound: a Prospective, Multicenter, Randomized, Open-label, Parallel-group Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 89 (actual)
• Sponsor: University Hospital, Toulouse · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Identifying patients at risk for postextubation distress using standard clinical criteria and the only available test the investigators have, that is, the spontaneous breathing trial (SBT) remains a challenging issue2. A cumulative body of evidence suggest that the decision to attempt extubation might be assisted by the use of thoracic ultrasound. This non-invasive, reproducible and fully bedside approach is able to provide accurate information about respiratory, cardiac and neuromuscular functions which are independent predictors of extubation outcome. Recently, the investigators have demonstrated that a combined thoracic ultrasound (CTUS) strategy based on lung ultrasound, echocardiography and diaphragm ultrasonographic assessment data performs better than routine clinical assessment to evaluate extubation readiness in medical and surgical ICU patients3. CTUS appears as a unique point of care precision medicine prognostic and diagnostic tool for the management of patients experiencing ARDS. Based on those premises, the investigators hypothesize that 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. This research is a national, multicenter, randomized, controlled, open-label, in parallel group. Patients will be randomized on 1:1 CTUS strategy group or standard strategy group, daily daily followed until extubation+48hours, reassessed at day 28 and at 3 months. In CTUS strategy group, a combined 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. In standard strategy group, 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.

Conditions

• COVID-19
• ARDS, Human
• Mechanical Ventilation

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	CTUS examination	fully bedside ultrasonographic assessment of lung, cardiac and diaphragm functions

Timeline

• Start date: 2020-04-22
• Primary completion: 2022-04-01
• Completion: 2022-04-01
• First posted: 2020-05-04
• Last updated: 2023-10-17

Locations

2 sites across 1 country: France