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

NCT ID: NCT04372680

Last Updated: 2023-10-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 89 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-22
• Study Completion Date: 2022-04-01

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

CTUS strategy group

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

Group Type: EXPERIMENTAL

CTUS examination

Intervention Type: DIAGNOSTIC_TEST

fully bedside ultrasonographic assessment of lung, cardiac and diaphragm functions

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

CTUS examination

fully bedside ultrasonographic assessment of lung, cardiac and diaphragm functions

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Toulouse

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Béatrice RIU-POULENC

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

CHU de LIMOGES

Limoges, , France

CHU de TOULOUSE

Toulouse, , France

Countries

France

Other Identifiers

2020-A00916-33

Identifier Type: OTHER

Identifier Source: secondary_id

RC31/20/0138

Identifier Type: -

Identifier Source: org_study_id