Incremental Dead Space Versus Capping Trial Before Tracheostomy Decannulation

NCT07810166 | Recruiting

• 2 other identifiers: 25042502811261441
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Tracheostomy; Prolonged Mechanical Ventilation; Tracheostomy Decannulation

Keywords

tracheostomy decannulation; capping trial; instrumental dead space; esophageal pressure; critical illness

Outcome Measures

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.

  During the final 10 minutes of each 45-minute pre-decannulation condition and during the post-decannulation assessment

Secondary Outcomes (4)

• Accessory Respiratory Muscle Surface Electromyography Activity

  Final 10 minutes of each 45-minute study condition and post-decannulation assessment

• Perceived Dyspnea / Respiratory Discomfort

  Beginning and end of each 45-minute study condition and when clinically indicated

• Esophageal Pressure Swing (ΔPes)

  Final 10 minutes of each 45-minute study condition and post-decannulation assessment

• Pressure-Time Product per Minute (PTPmin)

  Final 10 minutes of each 45-minute study condition and post-decannulation assessment

Study Arms (2)

Sequence A: Incremental Dead Space then Capping Trial

EXPERIMENTAL

Participants first undergo the incremental instrumental dead space trial for 45 minutes. After a 20-minute washout breathing spontaneously through an open T-piece connected to the tracheostomy, participants undergo the capping trial for 45 minutes. Following completion of both conditions and confirmation of decannulation by the clinical team, participants undergo post-decannulation assessment.

Other: Incremental Instrumental Dead Space; Other: Capping Trial

Sequence B: Capping Trial then Incremental Dead Space

EXPERIMENTAL

Participants first undergo the capping trial for 45 minutes. After a 20-minute washout breathing spontaneously through an open T-piece connected to the tracheostomy, participants undergo the incremental instrumental dead space trial for 45 minutes. Following completion of both conditions and confirmation of decannulation by the clinical team, participants undergo post-decannulation assessment.

Other: Incremental Instrumental Dead Space; Other: Capping Trial

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.

Sequence A: Incremental Dead Space then Capping Trial; Sequence B: Capping Trial then Incremental Dead Space

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.

Sequence A: Incremental Dead Space then Capping Trial; Sequence B: Capping Trial then Incremental Dead Space

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pontificia Universidad Catolica de Chile: lead

Study Sites (1)

Hospital Clínico UC CHRISTUS, Unidad de Paciente Crítico

Santiago, Santiago Metropolitan, Chile

RECRUITING

Related Publications (3)

• Nowak A, Martin S, Hohne M, Heller W, Usichenko TI, Klemm E. Tracheal airway pressure in tracheostomy tube capping trials: an experimental study. BMC Pulm Med. 2022 Dec 21;22(1):484. doi: 10.1186/s12890-022-02277-4.

  PMID: 36539764 BACKGROUND

• Devlin CJ, O'Bryan RS, Williams H, Capes KM, McCants T, Schoolcraft E. Improving Outcomes for Patients With Tracheostomy Through Implementation of AARC Clinical Practice Guidelines. Respir Care. 2025 Mar;70(3):243-248. doi: 10.4187/respcare.12080. Epub 2024 Nov 12.

  PMID: 39532496 BACKGROUND

• Basoalto R, Jalil Y, Guzman J, de la Fuente R, Damiani LF, Ibarra-Estrada M, Gorordo-Delsol L, Plotnikow G, Falcon N, Martin N, Munoz-Gama J, Sepulveda M, Kattan E. Tracheostomy decannulation process model: an interprofessional, Latin-American Delphi consensus. Med Intensiva (Engl Ed). 2026 Aug;50(8):502437. doi: 10.1016/j.medine.2026.502437. Epub 2026 Mar 2.

  PMID: 41775545 BACKGROUND

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Roque Basoalto Escobar, MSc, PhD

CONTACT

+56984463575; roque.basoalto@gmail.com

Eduardo Kattan Tala, MD, PhD

CONTACT

e.kattan@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Blinding of participants and bedside investigators is not feasible because the interventions are visibly different. Physiological signal analysis will be performed offline with the analysis blinded to the randomization sequence whenever feasible.
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Each participant is randomized to one of two sequences and receives both study conditions (incremental instrumental dead space and capping trial) in the assigned order, separated by a 20-minute washout period breathing spontaneously through an open T-piece connected to the tracheostomy, followed by assessment after actual tracheostomy decannulation.

Study Record Dates

• First Submitted: September 2, 2026
• First Posted: September 9, 2026
• Study Start: August 17, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: September 9, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)