Predictive Value of Chest Ultrasound Observation on Extubation Failure

NCT ID: NCT05944588

Last Updated: 2023-07-13

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-05-24
• Study Completion Date: 2024-05-22

Brief Summary

The use of mechanical ventilation in intensive care concerns the majority of patients, most often to compensate for respiratory failure, but for other organic failures requiring therapeutic artificial coma. During the sedation phase, many elements of management can modify the patient's clinical parameters.

Indeed, mechanical ventilation with a positive expiratory pressure mainly modifies the venous return by decreasing it, and therefore many modifications of the hemodynamic parameters result from it. In addition, other elements of management, such as iterative fillings, vasopressor and inotropic amines, as well as sedative drugs not only modify the hemodynamics, but also the ventilatory mechanics.

Extubate a patient in intensive care is always complex, because the assessment must be multifactorial and this is not without risk for the patient. Many complications can arise if it ends in failure. They can be linked to mechanical causes (laryngeal oedema, tracheal stenosis, pneumothorax...) but also to non-mechanical causes, such as inappropriate sedation, overload, neuromuscular deficit. Extubation is primarily based on the patient's level of consciousness, as well as the successful progress of the patient during a ventilatory weaning trial, carried out after a return to spontaneous ventilation with inspiratory support. This ventilatory weaning test precedes extubation and is performed for any patient intubated for more than 48 hours.

Since the 1950s, ultrasounds have become more and more important in the field of medical diagnosis and therapeutic decision support, even more recently in the world of intensive care. The contribution of echocardiography in a patient in the process of extubation has already been evaluated and has proven to be a valuable aid. For nearly 20 years, the use of pulmonary ultrasound has emerged and allows rapid diagnosis at the patient's bedside of mechanical anomalies such as gaseous or liquid effusion, an anomaly in the compliance of the pulmonary parenchyma, possibly in link with diaphragmatic dysfunction or even signs in favor of a picture of pulmonary overload, thanks to ultrasound artefacts such as B lines or even alveolar derecruitment by atelectasis.

The role of pulmonary ultrasound in helping to decide on extubation remains poorly established, we propose an observational study evaluating the predictive value of chest ultrasound in pre-extubation with the aim of determining if ultrasound signs are able to predict a potential failure of this extubation. Indeed, the risks of extubation failure being much higher than those of ventilatory weaning failure, it seems necessary to focus our research on this component.

This study must include patients in spontaneous mechanical invasive ventilation with pressure support, presenting the criteria for a ventilatory weaning test in view of a potential extubation.

Conditions

Pulmonary Ultrasound; Weaning Failure; Ultrasound; Lung Edema; Extubation Failure

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Extubation Success

Patients who don't need a new intubation in the 7 days following the extubation

Pulmonary Ultrasound

Intervention Type: OTHER

2 pulmonary ultrasound exams, one before respiratory weaning test, and one other at the end of the respiratory weaning test, before extubation

Extubation Failure

Patients who need a new intubation in the 7 days following the extubation

Pulmonary Ultrasound

Intervention Type: OTHER

2 pulmonary ultrasound exams, one before respiratory weaning test, and one other at the end of the respiratory weaning test, before extubation

Interventions

Pulmonary Ultrasound

2 pulmonary ultrasound exams, one before respiratory weaning test, and one other at the end of the respiratory weaning test, before extubation

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Adult patient with organ failure requiring intubation for more than 48 hours
• In spontaneous ventilation with pressure support
• Presenting the common criteria of the unit to start a ventilatory weaning test
• Richmond Agitation Sedation Scale 0

Exclusion Criteria

• Sedated patient with a score of 0 at the Richmond Agitation Sedation Scale
• Pregnant woman
• Patient under guardianship or curators or deprived of public rights
• Patient with a contraindication to performing an external ultrasound

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

Sponsors

University Hospital, Caen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Damien DD DUCHEYRON, PHD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Center of Caen

Locations

University Hospital Center

Caen, Calvados, France

Site Status: RECRUITING

Countries

France

Central Contacts

Damien DD DUCHEYRON, PHD

Role: CONTACT

ducheyron-d@chu-caen.fr

+33231064716 ext. 4716

Facility Contacts

Damien Du Cheyron, PHD

Role: primary

ducheyron-d@chu-caen.fr

0231064716 ext. 4716

Other Identifiers

23-0031

Identifier Type: -

Identifier Source: org_study_id