Preserving lung volume during extubation

Preserving Lung Volume During Weaning and Extubation. A Prospective, Multicenter Clinical Trial

This study tests two different ways to help patients safely come off a breathing machine to see which method keeps their lungs working better.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 1644 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Althaia Xarxa Assistencial Universitària de Manresa (Academic / other)
• Locations: 1 site (Manresa, Bacelona)
• Trial ID: NCT05526053 on ClinicalTrials.gov

What this trial studies

This study investigates two different approaches to extubation in patients weaning from mechanical ventilation, focusing on techniques that aim to preserve lung volume. Patients will be randomized to either a standard method with continuous suctioning or a lung volume preservation method without suctioning. The effectiveness of these approaches will be assessed using lung ultrasound to measure lung aeration and collapse. The goal is to determine which method yields higher rates of successful extubation.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 years who have been on mechanical ventilation for more than 24 hours and meet specific weaning criteria.

Not a fit: Patients with tracheostomy or do-not-reintubate orders may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to improved extubation success rates and better outcomes for patients recovering from mechanical ventilation.

How similar studies have performed: While some experiences suggest that extubation without suctioning is feasible and safe, this specific approach is novel and has not been extensively tested in prior studies.

Eligibility criteria

Inclusion Criteria:

* Patients\> 18 years who meet weaning criteria (see below)
* More than 24 hours of mechanical ventilation (MV)
* Signed Informed Consent by a substitute decision maker (SDM).

Weaning Criteria:

* Suitable cough (Ability to raise secretions to the endotracheal tube) (or Maximal inspiratory pressure (MIP) \< -15 cmH2O).
* Absence of excessive secretions (\<3 aspirations in the last 8 hours).
* Resolution or improvement of the pathology that led to intubation.
* Clinical stability (Heart Rate (HR) \<140 bpm, Systolic Blood Pressure (SBP) 90-160, without vasopressors or at minimum doses).
* Adequate oxygenation (SatO2\> 90% with Inspiratory Fraction of oxygen (FiO2) \<0.4).
* Adequate ventilatory mechanics (Respiratory rate (RR) \<35 rpm, Tidal Volume (TV) \> 5 ml / kg, RR / TV \<100 rpm/l).
* Confident awareness level (Glasgow Coma Scale (GCS)\> 13).

Exclusion Criteria:

* tracheostomy, do-not-reintubate orders, decision of the responsible physician (e.g., due to a preference for a particular weaning technique according to the underlying pathology), absence of informed consent, mental incapacity without legal representation.
* For ultrasound assessment: skilled explorer not present at the time of the SBT, inadequate ultrasound window. Known diaphragmatic paralysis.

Where this trial is running

Manresa, Bacelona

• Althaia Xarxa Assistencial — Manresa, Bacelona, Spain (Recruiting)

Study contacts

• Principal investigator: Carlos Subira, PhD — Althaia Xarxa Assitencial de Manresa
• Study coordinator: Carlos Subira, PhD

Conditions Weaning Failure; Pulmonary Collapse; Weaning from Mechanical Ventilation; Reintubation; Lung Ultrasound Score; Diaphragm and intercostal thickness and thickening fraction