TracheostomyNCT07810166
Incremental Dead Space Versus Capping Trial Before Tracheostomy Decannulation
A study testing Incremental Instrumental Dead Space and Capping Trial in people with Tracheostomy and Prolonged Mechanical Ventilation, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tracheostomy, Prolonged Mechanical Ventilation, Tracheostomy Decannulation
- What is being tested?
- Incremental Instrumental Dead Space and Capping Trial
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteChile
- Study dates
- 17 Aug 2026to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Eduardo Kattan Tala, MD, PhD contact
Chile1 site, 1 recruiting
- Recruiting
Hospital Clínico UC CHRISTUS, Unidad de Paciente Crítico
Santiago, Santiago Metropolitan
Roque Basoalto Escobar, MSc, PhD, +56984463575, ROQUE.BASOALTO@GMAIL.COM
About this study
Official title: Incremental Dead Space Versus Capping Trial to Predict the Post-Decannulation Respiratory Status in Tracheostomized Critically Ill Patients: A Physiological Randomized Crossover Study
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.
Read the detailed description
Approximately 10-15% of mechanically ventilated intensive care unit (ICU) patients require prolonged mechanical ventilation, and tracheostomy is frequently used to facilitate weaning and respiratory rehabilitation in this population. Tracheostomy decannulation is a key recovery milestone, but there is no standardized method for confirming readiness. The tracheostomy capping trial, in which the tube is occluded to redirect airflow through the upper airway, is the most widely used final assessment prior to decannulation; however, because the tracheostomy tube remains in place, it substantially narrows the airway lumen and may increase airflow resistance up to 16-fold compared to true post-decannulation breathing (per Poiseuille's law). This supraphysiological load may cause capping trial failure in patients who would otherwise tolerate decannulation, particularly those with pre-existing respiratory muscle weakness related to ICU-acquired weakness, which affects up to 80% of patients requiring prolonged mechanical ventilation.
Preliminary physiological data from the investigators' group (unpublished) demonstrated that the esophageal pressure-time product (PTP), a validated marker of the work of breathing, increased by 226% during capping trials compared to baseline, then decreased after actual decannulation to levels close to baseline, suggesting the capping trial substantially overestimates the respiratory burden that patients will face after tube removal.
This study proposes an alternative physiological assessment using incremental instrumental dead space, which reproduces the anatomical dead space increase that occurs after decannulation without imposing the artificial airway resistance created by the tracheostomy tube during capping. In a randomized crossover design, each participant will undergo both the capping trial and the incremental dead space strategy in random order, followed by assessment after actual decannulation, allowing within-participant comparison of which method better predicts the true post-decannulation respiratory status.
- Being tested
- Incremental Instrumental Dead Space, Capping Trial
- Keywords
- tracheostomy decannulation, capping trial, instrumental dead space, esophageal pressure, critical illness
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Incremental Instrumental Dead SpaceOther
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 TrialOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Incremental Instrumental Dead Space; Other: Capping Trial |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: Final 10 minutes of each 45-minute study condition and post-decannulation assessment
Perceived Dyspnea / Respiratory Discomfort
Participant-reported respiratory discomfort assessed using the modified Borg scale from 0 to 10.
Measured: Beginning and end of each 45-minute study condition and when clinically indicated
Esophageal Pressure Swing (ΔPes)
Mean inspiratory esophageal pressure swing measured from the esophageal pressure signal as an index of inspiratory effort.
Measured: Final 10 minutes of each 45-minute study condition and post-decannulation assessment
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.
Measured: Final 10 minutes of each 45-minute study condition and post-decannulation assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2026
- Study start17 Aug 2026
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for TracheostomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pontificia Universidad Catolica de Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07810166
- Sponsor's protocol ID
- 250425028
- Other IDs
- 11261441
- Status last verified
- Aug 2026
- First submitted
- 2 Sep 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared beyond the study team, given the small single-center sample size and the identifiability risk associated with detailed physiological and clinical data from a small, specific patient population.
Publications
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.
PubMed 36539764Devlin 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.
PubMed 39532496Basoalto 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.
PubMed 41775545
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incremental Dead Space Versus Capping Trial to Predict the Post-Decannulation Respiratory Status in Tracheostomized Critically Ill Patients: A Physiological Randomized Crossover Study
- ClinicalTrials.gov ID
- NCT07810166
- Acronym / sponsor ID
- 250425028
- Keywords
- tracheostomy decannulation, capping trial, instrumental dead space, esophageal pressure, critical illness
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Pontificia Universidad Catolica de ChileUniversity, hospital or other
- Study start
- 17 Aug 2026 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 9 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Approximately 10-15% of mechanically ventilated intensive care unit (ICU) patients require prolonged mechanical ventilation, and tracheostomy is frequently used to facilitate weaning and respiratory rehabilitation in this population. Tracheostomy decannulation is a key recovery milestone, but there is no standardized method for confirming readiness. The tracheostomy capping trial, in which the tube is occluded to redirect airflow through the upper airway, is the most widely used final assessment prior to decannulation; however, because the tracheostomy tube remains in place, it substantially narrows the airway lumen and may increase airflow resistance up to 16-fold compared to true post-decannulation breathing (per Poiseuille's law). This supraphysiological load may cause capping trial failure in patients who would otherwise tolerate decannulation, particularly those with pre-existing respiratory muscle weakness related to ICU-acquired weakness, which affects up to 80% of patients requiring prolonged mechanical ventilation.
Preliminary physiological data from the investigators' group (unpublished) demonstrated that the esophageal pressure-time product (PTP), a validated marker of the work of breathing, increased by 226% during capping trials compared to baseline, then decreased after actual decannulation to levels close to baseline, suggesting the capping trial substantially overestimates the respiratory burden that patients will face after tube removal.
This study proposes an alternative physiological assessment using incremental instrumental dead space, which reproduces the anatomical dead space increase that occurs after decannulation without imposing the artificial airway resistance created by the tracheostomy tube during capping. In a randomized crossover design, each participant will undergo both the capping trial and the incremental dead space strategy in random order, followed by assessment after actual decannulation, allowing within-participant comparison of which method better predicts the true post-decannulation respiratory status.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Sequence A: Incremental Dead Space then Capping Trial | Experimental | Other: Incremental Instrumental Dead Space, Other: Capping TrialParticipants 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. |
| Sequence B: Capping Trial then Incremental Dead Space | Experimental | Other: Incremental Instrumental Dead Space, Other: Capping TrialParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Incremental Instrumental Dead SpaceInstrumental 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. | Other | Sequence A: Incremental Dead Space then Capping Trial, Sequence B: Capping Trial then Incremental Dead Space |
| Capping TrialThe 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. | Other | Sequence A: Incremental Dead Space then Capping Trial, Sequence B: Capping Trial then Incremental Dead Space |
Primary outcome
Within-Participant Absolute Error in Pressure-Time Product Post-Decannulation Breathing
Time frame: During the final 10 minutes of each 45-minute pre-decannulation condition and during the post-decannulation assessment
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.
4 secondary outcomes
Accessory Respiratory Muscle Surface Electromyography Activity
Time frame: Final 10 minutes of each 45-minute study condition and post-decannulation assessment
Perceived Dyspnea / Respiratory Discomfort
Time frame: Beginning and end of each 45-minute study condition and when clinically indicated
Esophageal Pressure Swing (ΔPes)
Time frame: Final 10 minutes of each 45-minute study condition and post-decannulation assessment
Pressure-Time Product per Minute (PTPmin)
Time frame: Final 10 minutes of each 45-minute study condition and post-decannulation assessment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Background: PubMed 36539764Nowak 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.
- Background: PubMed 39532496Devlin 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.
- Background: PubMed 41775545Basoalto 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.
- Individual participant dataSharing planned: No. Individual participant data will not be shared beyond the study team, given the small single-center sample size and the identifiability risk associated with detailed physiological and clinical data from a small, specific patient population.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Eduardo Kattan Tala, MD, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Incremental Instrumental Dead Space and Capping Trial in people with Tracheostomy and Prolonged Mechanical Ventilation, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Roque Basoalto Escobar, MSc, PhD (+56984463575, roque.basoalto@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Within-Participant Absolute Error in Pressure-Time Product Post-Decannulation Breathing (time frame: During the final 10 minutes of each 45-minute pre-decannulation condition and during the post-decannulation assessment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07810166, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026; AzTrials last refreshed its copy on 27 Oct 2026.