Predictive Value of Chest Ultrasound Observation on Extubation Failure

NCT05944588 | Unknown DMC

• 1 other identifier: 23-0031
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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

Keywords

Extubation; Weaning Failure; Lung Ultrasound; Chest Ultrasound; B Lines

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Determine at wich range of pathological ultrasound observations there's a positive correlation with extubation failure

  7 days

Study Arms (2)

Extubation Success

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

Other: Pulmonary Ultrasound

Extubation Failure

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

Other: Pulmonary Ultrasound

Interventions

Pulmonary Ultrasound 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; Extubation Success

Eligibility Criteria

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

Study Population

All patients in the intensive care unit of the University hospital of Caen, presenting the Eligibility criteria without any exclusion criteria, intubated since more than 48h, presenting the common criteria of the unit to start a ventilatory weaning test

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Caen: lead

Study Sites (1)

University Hospital Center

Caen, Calvados, 14000, France

RECRUITING

MeSH Terms

Conditions

Pulmonary Edema

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Study Officials

• Damien DD DUCHEYRON, PHD

  University Hospital Center of Caen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Damien DD DUCHEYRON, PHD

CONTACT

+33231064716; ducheyron-d@chu-caen.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 7 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2023
• First Posted: July 13, 2023
• Study Start: May 24, 2023
• Primary Completion: May 22, 2024
• Study Completion: May 22, 2024
• Last Updated: July 13, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)