Incremental Instrumental Dead Space vs Capping Trial Before Removing a Tracheostomy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Critically ill adults with a tracheostomy who are ready to decannulate are randomized to two approaches: a standard capping trial or an incremental instrumental dead space setup that preserves an open airway. The goal is to see if the dead space method better predicts post-decannulation breathing ease by reducing airway resistance compared to the blocked-tube test. Researchers will monitor markers of respiratory effort, such as esophageal pressure-time product, and track decannulation outcomes. The study addresses whether a less obstructive assessment can shorten time to decannulation and reduce unnecessary delays. Safety monitoring and institutional criteria for decannulation remain in place as part of standard care.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Adult patients (≥18 years) admitted to the ICU.
* Presence of a tracheostomy due to prolonged mechanical ventilation (≥14 days).
* Clinically considered ready for decannulation, according to institutional criteria (e.g., stable gas exchange, minimal secretions, effective cough, and tolerance to spontaneous breathing).
* Ability to maintain spontaneous breathing without mechanical ventilation for more than 48 consecutive hours.
* Able to cooperate and follow basic commands (RASS between -1 and +1).
* Written informed consent obtained from patient.

Exclusion Criteria:

* Neuromuscular disease affecting respiratory muscles (e.g., myasthenia gravis, Guillain-Barre syndrome, amyotrophic lateral sclerosis).
* Hemodynamic instability.
* Severe agitation or delirium precluding cooperation (RASS \< -2 or \> +2).
* Structural airway abnormalities (e.g., subglottic stenosis, tracheomalacia).
* Pregnancy.
* Contraindications for esophageal balloon catheter insertion (e.g., severe coagulopathy, esophageal varices, and history of esophageal or gastric surgery).
* Refusal to participate by the attending physician.

Where it's running

• Hospital Clínico UC CHRISTUS, Unidad de Paciente Crítico
  Santiago, Santiago Metropolitan, Chile Recruiting

Study contacts

• Study coordinator: Roque Basoalto Escobar, MSc, PhD
• Email: roque.basoalto@gmail.com
• Phone: +56984463575

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.