ECHOEXTUB: Predictive Value of Chest Ultrasound Observation on Extubation Failure

Sponsor
University Hospital, Caen (Other)
Overall Status
Recruiting
CT.gov ID
NCT05944588
Collaborator
(none)
150
1
12
12.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Pulmonary Ultrasound

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
150 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Predictive Value of Chest Ultrasound Observation on Extubation Failure
Actual Study Start Date :
May 24, 2023
Anticipated Primary Completion Date :
May 22, 2024
Anticipated Study Completion Date :
May 22, 2024

Arms and Interventions

Arm Intervention/Treatment
Extubation Success

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

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

Extubation Failure

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

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

Outcome Measures

Primary Outcome Measures

  1. Determine if pulmonary ultrasound observations are predictive factors linked with extubation failure [7 days]

    See if there's more pathological ultrasound signs in the extubation failure group

Secondary Outcome Measures

  1. Determine at wich range of pathological ultrasound observations there's a positive correlation with extubation failure [7 days]

    See if there 's a specific range number of pathological observations, where we can start to see a link with the extubation failure

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Hospital Center Caen Calvados France 14000

Sponsors and Collaborators

  • University Hospital, Caen

Investigators

  • Principal Investigator: Damien DD DUCHEYRON, PHD, University Hospital Center of Caen

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Caen
ClinicalTrials.gov Identifier:
NCT05944588
Other Study ID Numbers:
  • 23-0031
First Posted:
Jul 13, 2023
Last Update Posted:
Jul 13, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University Hospital, Caen
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 13, 2023