Prediction of Outcome of Weaning From Mechanical Ventilation Using the Electrical Activity of the Diaphragm

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

110 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-09-30

Study Completion Date

2021-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Several types of spontaneous breathing trials (SBTs) have been proposed to evaluate when a patient is ready to be weaned from the ventilator based on breathing pattern measurements. The T-piece technique allows clinicians to calculate breathing patterns accurately but many prefer to use minimal levels of assistance, which unfortunately modifies breathing pattern. The interest of Neurally Adjusted Ventilatory Assist (NAVA) is that tidal volume (Vt) supposedly represents what the patient really wants: without disconnecting the patient from the ventilator, it may be possible to determine what is the real need and whether the patient is able to maintain Vt without support. The aims of the study are as follows: to test whether the changes in Vt after the removal of a standardized level of NAVA assistance (ΔVt) can predict weaning outcome; to compare the proposed titration of effort in NAVA (occlusion) with Patient-Ventilator Breath Contribution (PVBC) and titration using the Pmusc/Eadi index (PEI) relating the pressure generated by the respiratory muscles (muscular pressure; Pmusc) to the electrical activity of the diaphragm (EAdi); to assess the effect of PEEP on the change in Vt; and to evaluate EAdi after extubation. Patients ventilated for at least 24 hours who are ready to undergo an SBT will be included. Patients younger than 18 years of age and/or who have a contraindication to NAVA catheter insertion and/or surgical patients expected to be extubated within 12 hours will be excluded. After a baseline inclusion period with the pre-enrollment mode of ventilation, the standardized NAVA level will be applied for 20 minutes, during which both Patient-Ventilator Breath Contribution (PVBC) and PEI will be calculated. After the NAVA trial, a period of Continuous Positive Airway Pressure (CPAP) 5 (2-3 minutes) followed by a period of CPAP 0 (2-3 minutes) (both with NAVA gain 0) will be performed in order to record the difference with Vt during standardized NAVA (ΔVt). At the end of this period, the patient will be switched back to the baseline settings for 30 minutes-3 hours. After this period, the patient will perform an SBT with CPAP 0 or CPAP 5 for 1 hour. At the end of the SBT, the attending physician will decide whether or not to extubate the patient according to standard criteria and blinded to the ΔVt results. Ultimately, patients will be classified as "success" or "failure" and the ΔVt will be compared between these two groups.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Value of Diaphragm Function Predicting Weaning From Mechanical Ventilation

NCT05632822

Weaning Failure Diaphragm Defect

UNKNOWN

Monitoring Intercostal Muscles After Extubation

NCT02853201

Respiratory Insufficiency

COMPLETED

Automated Ventilator Controlled Weaning vs Daily Spontaneous Breathing Trial in Difficult to Wean ICU Patients

NCT00813839

Mechanical Ventilation Weaning

WITHDRAWN PHASE4

Mechanical Ventilation- Weaning and Thoracic Impedance Tomography

NCT03018483

Weaning From Mechanical Ventilation

UNKNOWN NA

A Diaphragmatic Electrical Activity Based Optimization Strategy During Pressure Support Ventilation

NCT02067403

Respiratory Insufficiency

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Respiratory Insufficiency

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients ready to undergo an SBT based on the decision of the clinical team.
* Patients ventilated for at least 24 hours

Exclusion Criteria

* Patients younger than 18 years-old
* Contraindication to NAVA catheter insertion (e.g., recent surgery, bleeding)
* Central Neurological disorder (hemorrhage, tumor, massive stroke, etc.) heavily influencing breathing pattern
* Surgical patients expected to be extubated within 12 hours.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No