Incremental Dead Space Versus Capping Trial Before Tracheostomy Decannulation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorPontificia Universidad Catolica de Chile
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial design
Design model
Crossover
Treatments tested in this trial
Incremental Instrumental Dead Space
Other interventionInstrumental 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 interventionThe 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.
Treatment groups
22 Participants
are divided into 2 treatment groupsGroup A: Sequence A: Incremental Dead Space then Capping TrialExperimental treatment 2 interventions
Group B: Sequence B: Capping Trial then Incremental Dead SpaceExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Within-Participant Absolute Error in Pressure-Time Product Post-Decannulation Breathing
Respiratory effort will be quantified using the esophageal pressure-time product per breath (PTP), calculated from the esophageal pressure signal. For each pre-decannulation strategy, predictive accuracy will be quantified as the absolute within-participant difference between PTP measured during that strategy and PTP measured during post-decannulation spontaneous breathing. The primary comparison will assess whether the absolute error is lower during incremental instrumental dead space than during the capping trial.
Time frame
During the final 10 minutes of each 45-minute pre-decannulation condition and during the post-decannulation assessmentSecondary outcomes
1
Accessory Respiratory Muscle Surface Electromyography Activity
Surface electromyography will quantify respiratory muscle recruitment in the sternocleidomastoid, intercostal/parasternal, and abdominal muscles. Signal amplitude and prespecified frequency-domain characteristics will be analyzed offline according to the final signal-processing plan.
Time frame
Final 10 minutes of each 45-minute study condition and post-decannulation assessment2
Perceived Dyspnea / Respiratory Discomfort
Participant-reported respiratory discomfort assessed using the modified Borg scale from 0 to 10.
Time frame
Beginning and end of each 45-minute study condition and when clinically indicated3
Esophageal Pressure Swing (ΔPes)
Mean inspiratory esophageal pressure swing measured from the esophageal pressure signal as an index of inspiratory effort.
Time frame
Final 10 minutes of each 45-minute study condition and post-decannulation assessment4
Pressure-Time Product per Minute (PTPmin)
Pressure-time product per minute, calculated from the esophageal pressure signal by integrating the per-breath pressure-time product over one minute of recording.
Time frame
Final 10 minutes of each 45-minute study condition and post-decannulation assessmentSponsors and contacts
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Source ClinicalTrials.gov