Assessing Inspiratory Effort Using Endotracheal Tube Cuff Pressure

Use of Endotracheal Tube Cuff Pressure to Assess Inspiratory Effort During Pressure Support Ventilation: a Prospective Physiological Study

This study is testing if measuring the pressure in the cuff of a breathing tube can help doctors better understand how well patients on ventilators are breathing and improve their care.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 26 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Capital Medical University (Academic / other)
• Locations: 1 site (Beijing, Beijing)
• Trial ID: NCT06968793 on ClinicalTrials.gov

What this trial studies

This study investigates the correlation between cuff pressure and esophageal pressure in mechanically ventilated patients undergoing tracheal intubation or tracheotomy. By monitoring changes in cuff pressure alongside esophageal pressure, the study aims to determine if cuff pressure can serve as a non-invasive surrogate for assessing intrathoracic pressure during pressure support ventilation. The goal is to optimize ventilation strategies and reduce complications associated with mechanical ventilation. This approach could simplify monitoring and improve patient outcomes in critical care settings.

Who should consider this trial

Good fit: Ideal candidates for this study are mechanically ventilated patients who can tolerate pressure support ventilation and meet specific respiratory and hemodynamic stability criteria.

Not a fit: Patients who are hemodynamically unstable or have significant respiratory instability may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more convenient and non-invasive method for monitoring intrathoracic pressure in mechanically ventilated patients.

How similar studies have performed: Preliminary studies have shown correlations between cuff pressure and esophageal pressure, suggesting potential success for this approach, although it remains relatively novel.

Eligibility criteria

Inclusion Criteria:

1. Mechanically ventilated patients who can tolerate pressure support ventilation (PSV) mode;
2. Respiratory stability: Ability to breathe spontaneously and effectively clear secretions via coughing; oxygen saturation (SpO₂) \>90% or a partial pressure of oxygen (PaO₂)/FiO₂ ratio ≥150 mmHg when the ventilator's oxygen concentration is set to 40%;
3. Hemodynamic stability: Heart rate (HR) ≤120 bpm, systolic blood pressure (SBP) 90-150 mmHg, with no vasoactive agents or norepinephrine dosage ≤0.1-0.2 μg/kg·min (or equivalent doses of other vasoactive agents);
4. Metabolic stability, with an esophageal pressure monitoring catheter already placed prior to the trial;
5. Written informed consent obtained from the patient or their legal guardian.

Exclusion Criteria:

1. Age \<18 years;
2. Pregnancy;
3. Hemodynamic instability: Mean arterial pressure (MAP) \<60 mmHg, heart rate (HR) \>120 bpm or \<60 bpm;
4. Respiratory instability: Respiratory rate (RR) \>35 bpm or oxygen saturation (SpO₂) \<90%;
5. Neuromuscular disorders or phrenic nerve injury;
6. Recent trauma or surgery involving the trachea, esophagus, neck, or thorax, contraindications to esophageal catheter insertion, or inability to monitor esophageal pressure;
7. High bleeding risk: Severe coagulopathy/bleeding disorders, esophageal/gastric varices, etc.

Where this trial is running

Beijing, Beijing

• Beijing Shijitan Hospital — Beijing, Beijing, China (Recruiting)

Study contacts

• Principal investigator: Jian-Xin Zhou, MD, PhD — Capital Medical University
• Study coordinator: Jian-Xin Zhou, MD, PhD

Conditions Mechanical Ventilation; Critical Care; Inspiratory Effort; Esophageal pressure; mechanical ventilation; Endotracheal tube cuff pressure; inspiratory effort