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Status unknownNCT05944588ECHOEXTUBUpdated Jul 13, 2023

Predictive Value of Chest Ultrasound Observation on Extubation Failure

An observational study in Pulmonary Ultrasound, Weaning Failure and Ultrasound, sponsored by University Hospital, Caen. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-07-13.

Sponsored by University Hospital, Caen · Observational

The sponsor has not verified this record recently (last verified May 2023), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
150
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

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

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Keywords

  • Extubation
  • Weaning Failure
  • Lung Ultrasound
  • Chest Ultrasound
  • B Lines
03

In context

Pulmonary Edema

142 studies on the registry are indexed under Pulmonary Edema; 24 are open to participants now.

This study's planned enrollment of 150 is above the median of 120 across 59 observational studies indexed under Pulmonary Edema.

Browse Pulmonary Edema studies →

Lead sponsor

University Hospital, Caen is the lead sponsor of 510 studies on the registry; 80 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
150 participants (estimated)
Target follow-up
7 Days
Patient registry
Yes

Groups and cohorts

  • 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

  • OtherPulmonary Ultrasound

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

06

What researchers measure

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

    Time frame: 7 days

Secondary outcomes

  1. 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

    Time frame: 7 days

07

Study locations

1 of 1 sites recruiting
  • University Hospital Center
    Caen, Calvados 14000, France
    • Damien Du Cheyron, PHD · Contact · ducheyron-d@chu-caen.fr · 0231064716
    • Arthur PLE, Intern · Sub investigator
    • Xavier VALETTE, PH · Sub investigator
    • Augustin DELCAMPE, Assistant · Sub investigator
    • Suzanne GOURSAUD, MCU · Sub investigator
    • Mathieu BELLAL, Assistant · Sub investigator
    • Pierre CUCHET, PH · Sub investigator
    • Pierrick BAUDUIN, Assistant · Sub investigator
    • Célia DE CARVALHO RIBEIRO, Junior Doctor · Sub investigator
    Recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 13, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05944588
Responsible party
Sponsor
First posted
Jul 13, 2023
Start date
May 24, 2023
Primary completion
May 22, 2024 (estimated)
Completion
May 22, 2024 (estimated)
Last update
Jul 13, 2023

Study contacts

Damien DD DUCHEYRON, PHD
Contact
ducheyron-d@chu-caen.fr
+33231064716 ext. 4716
Damien DD DUCHEYRON, PHD
principal investigator · University Hospital Center of Caen

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2023. You cannot join it, but the record below documents what was studied.

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