Ultrasound Assessment During Weaning from Mechanical Ventilation

NCT06609798 | Enrolling By Invitation

• 1 other identifier: CEPI N° 12246
• Study Type: observational
• Target: 429
• Locations: 1 country
• Sites: 1

Brief Summary

The ECO-WEANING study aims to improve the process of safely removing patients from mechanical ventilation in the Intensive Care Unit (ICU). Some patients have difficulty breathing on their own after being on a ventilator, which can lead to longer hospital stays and complications. This study will use ultrasound to assess lung, heart, and diaphragm function before removing the ventilator. Combining these ultrasound results, we hope to identify better patients at high risk of needing mechanical ventilation again. The goal is to help guide care decisions and improve recovery, reducing the need for re-intubation or other interventions.

Conditions

Ventilated Patients; Weaning Invasive Mechanical Ventilation; ICU; Ultrasound

Keywords

Mechanical ventilation; Ultrasound; intensive care unit; Extubation; diaphragm; Lung Ultrasound

Outcome Measures

Primary Outcomes (1)

• To develop a predictive model for extubation failure using lung ultrasound, echocardiography, and diaphragmatic parameters

  The primary objective of this study is to develop a predictive model for extubation failure by utilizing lung ultrasound, echocardiography, and diaphragmatic parameters. This model aims to improve the accuracy of identifying patients at risk of re-intubation or other complications after being taken off mechanical ventilation.

  The primary outcome assessment period comprises the first 48 hours after extubation.

Secondary Outcomes (4)

• To assess the predictive accuracy of the ultrasound model in patients who do not require non-invasive ventilation as a preventive measure against failure

  The evaluation period comprises the first 48 hours after extubation.

• Evaluate the predictive performance of the ultrasound model in patients with indication for preventive non-invasive ventilation

  The evaluation period comprises the first 48 hours after extubation.

• Examine the correlation between clinical criteria for preventive non-invasive ventilation and the ultrasound model's predictions

  The evaluation period comprises the first 48 hours after extubation.

• Describe the proportion of extubation failure within 7 days after extubation

  The evaluation period includes the first 7 days after extubation.

Study Arms (1)

Adult patients during the period of weaning from mechanical ventilation

Adult patients (age ≥18 years) who have been on invasive mechanical ventilation via an endotracheal tube for at least 48 hours and are eligible to begin a spontaneous breathing trial in T-tube mode will be included. Cardiac, diaphragmatic, and pulmonary ultrasound measurements will be performed between 20 and 30 minutes after the start of the spontaneous breathing trial. The ultrasound sequence includes: 1) modified Lung Ultrasound Score (LUS), 2) left ventricular systolic function assessed by MAPSE, 3) right ventricular systolic function assessed by TAPSE, 4) left ventricular diastolic function via E/e' ratio, 5) diaphragmatic excursion, and 6) diaphragmatic thickening fraction.

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

Patients hospitalized in critical care units in Latin American countries (Argentina, Bolivia, Ecuador, Chile) and Europe (Italy and Spain) will be included.

You may qualify if:

• Adult patients (18 years or older).
• Receiving mechanical ventilatory assistance for more than 48 hours.
• The patient is deemed ready to undergo a Spontaneous Breathing Trial, as determined by the attending physician.
• Ultrasound measurements are performed between 20 and 30 minutes after the initiation of the trial.

You may not qualify if:

• Patients with known or diagnosed neuromuscular disease.
• Limitation of therapeutic effort
• History of severe valvulopathy, severe coronary artery disease, known left ventricular ejection fraction \<35%, or known grade 3 diastolic dysfunction, or who are considered candidates for tracheostomy due to their severity.
• History of home ventilatory support
• Patients who do not have a good acoustic window or have any type of limitation to perform pulmonary, cardiac, or diaphragmatic ultrasound.
• Patients who at the discretion of the treating medical team cannot be placed on a T-tube.

Sponsors & Collaborators

• Hospital Italiano de Buenos Aires: lead

Study Sites (1)

Hospital Italiano de Buenos AIres

Buenos Aires, Buenos Aires F.D., C1181ACH, Argentina

Location

Related Publications (1)

• 1. Frutos-Vivar F, Ferguson ND, Esteban A, Epstein SK, Arabi Y, Apezteguía C, et al. Risk factors for extubation failure in patients following a successful spontaneous breathing trial. Chest. 2006 Dec;130(6):1664-71. 2. Ouanes-Besbes L, Dachraoui F, Ouanes I, Bouneb R, Jalloul F, Dlala M, et al. NT-proBNP levels at spontaneous breathing trial help in the prediction of post-extubation respiratory distress. Intensive Care Med. 2012 May;38(5):788-95. 3. Levine S, Nguyen T, Taylor N, Friscia ME, Budak MT, Rothenberg P, et al. Rapid disuse atrophy of diaphragm fibers in mechanically ventilated humans. N Engl J Med. 2008 Mar 27;358(13):1327-35. 4. Peñuelas O, Frutos-Vivar F, Fernández C, Anzueto A, Epstein SK, Apezteguía C, et al. Characteristics and outcomes of ventilated patients according to time to liberation from mechanical ventilation. Am J Respir Crit Care Med. 2011 Aug 15;184(4):430-7. 5. Powers SK, Kavazis AN, Levine S. Prolonged mechanical ventilation alters diaphragmatic structure and function. Crit Care Med. 2009 Oct;37(10 Suppl):S347-53. 6. Trivedi V, Chaudhuri D, Jinah R, Piticaru J, Agarwal A, Liu K, et al. The Usefulness of the Rapid Shallow Breathing Index in Predicting Successful Extubation: A Systematic Review and Meta-analysis. Chest. 2022 Jan;161(1):97-111. 7. Soummer A, Perbet S, Brisson H, Arbelot C, Constantin JM, Lu Q, et al. Ultrasound assessment of lung aeration loss during a successful weaning trial predicts postextubation distress*. Crit Care Med. 2012 Jul;40(7):2064-72. 8. Bouhemad B, Liu ZH, Arbelot C, Zhang M, Ferarri F, Le-Guen M, et al. Ultrasound assessment of antibiotic-induced pulmonary reaeration in ventilator-associated pneumonia. Crit Care Med. 2010 Jan;38(1):84-92. 9. Bouhemad B, Brisson H, Le-Guen M, Arbelot C, Lu Q, Rouby JJ. Bedside ultrasound assessment of positive end-expiratory pressure-induced lung recruitment. Am J Respir Crit Care Med. 2011 Feb 1;183(3):341-7. 10. Volpicelli G, Elbarbary M, Blaivas M, Lichtenstein DA, Math

  BACKGROUND

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: September 19, 2024
• First Posted: September 24, 2024
• Study Start: June 10, 2024
• Primary Completion: January 1, 2025
• Study Completion: February 1, 2025
• Last Updated: September 24, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

AR (1)