Predictive Value of Chest Ultrasound Observation on Extubation Failure

Ultrasound Clinical Trial

— ECHOEXTUB  

Official title:

Predictive Value of Chest Ultrasound Observation on Extubation Failure

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05944588
• Other study ID #: 23-0031
• Status: Recruiting
• Start date: May 24, 2023
• Est. completion date: May 22, 2024

Study information

• Verified date: May 2023
• Source: University Hospital, Caen
• Contact: Damien DD DUCHEYRON, PHD
• Phone: +33231064716
• Email: ducheyron-d[@]chu-caen.fr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: May 22, 2024
• Est. primary completion date: May 22, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Extubation Failure
• Lung Edema
• Pulmonary Edema
• Ultrasound
• Weaning Failure

Intervention

Other:
• Pulmonary Ultrasound
2 pulmonary ultrasound exams, one before respiratory weaning test, and one other at the end of the respiratory weaning test, before extubation

Locations

Country	Name	City	State
France	University Hospital Center	Caen	Calvados

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine if pulmonary ultrasound observations are predictive factors linked with extubation failure	See if there's more pathological ultrasound signs in the extubation failure group	7 days
Secondary	Determine at wich range of pathological ultrasound observations there's a positive correlation with extubation failure	See if there 's a specific range number of pathological observations, where we can start to see a link with the extubation failure	7 days