Incremental Dead Space Versus Capping Trial to Predict the Post-Decannulation Respiratory Status in Tracheostomized Critically Ill Patients: A Physiological Randomized Crossover Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Within-Participant Absolute Error in Pressure-Time Product Post-Decannulation Breathing
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- None
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Sequence A: Incremental Dead Space then Capping Trial
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.
干预措施: Incremental Instrumental Dead Space (Other)
Sequence A: Incremental Dead Space then Capping Trial
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.
干预措施: Capping Trial (Other)
Sequence B: Capping Trial then Incremental Dead Space
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.
干预措施: Incremental Instrumental Dead Space (Other)
Sequence B: Capping Trial then Incremental Dead Space
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.
干预措施: Capping Trial (Other)
结局指标
主要结局
Within-Participant Absolute Error in Pressure-Time Product Post-Decannulation Breathing
时间窗: 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.
次要结局
- 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)