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Incremental Dead Space Versus Capping Trial Before Tracheostomy Decannulation

Sponsor: Pontificia Universidad Catolica de Chile • ClinicalTrials.gov ID: NCT07810166

Registry updated: 2026-09-09

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Description

Some critically ill patients need a breathing tube placed directly into the windpipe (tracheostomy) because they require long-term help from a breathing machine. Before this tube can be safely removed (decannulation), medical team need to confirm the patient is ready to breathe on their own through the nose and mouth again. The most common way to check this is a "capping trial," in which the tube is blocked so air must pass through the upper airway, similar to normal breathing. However, because the tube itself remains in place during this test, it narrows the airway and may make breathing harder than it would be if the tube were actually removed. This could cause some patients to fail the test even though they are truly ready for the tube to come out, leading to unnecessary delays. This study will compare the standard capping trial with a new approach that instead adds extra tubing (dead space) to the breathing circuit, without blocking the airway, to more closely copy the breathing effort patients will experience once the tube is removed. Each participant will undergo both methods, in random order, during a single study day, with breathing effort, muscle activity, and comfort measured during each method and again after the tube is actually removed. The goal is to determine which method more accurately predicts how a patient will actually breathe once the tracheostomy tube is taken out.

Interventions

Incremental Instrumental Dead Space (Other)
Instrumental dead space applied through a modular low-resistance circuit connected to the tracheostomy for 45 minutes, intended to reproduce the respiratory demand associated with restoration of the upper airway after decannulation.
Capping Trial (Other)
The tracheostomy cuff is deflated and the tube is completely occluded with a standard cap, requiring the participant to breathe through the upper airway for 45 minutes unless predefined intolerance or safety criteria require earlier discontinuation.

Eligibility criteria

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.

Conditions

Tracheostomy Prolonged Mechanical Ventilation Tracheostomy Decannulation

Locations

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

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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