Status:
RECRUITING
Use of Endotracheal Tube Cuff Pressure to Assess Inspiratory Effort During Pressure Support Ventilation
Lead Sponsor:
Jian-Xin Zhou
Conditions:
Mechanical Ventilation
Critical Care
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
During pressure support ventilation (PSV), monitoring of Esophageal Pressure (Pes) has long been considered the gold standard for assessing intrathoracic pressure and the state of respiratory mechanic...
Detailed Description
Monitoring of Esophageal pressure (Pes) has long been regarded as the gold standard for assessing intrathoracic pressure and respiratory mechanics. The measurement of Esophageal pressure provides indi...
Eligibility Criteria
Inclusion
- Mechanically ventilated patients who can tolerate pressure support ventilation (PSV) mode;
- 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%;
- 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);
- Metabolic stability, with an esophageal pressure monitoring catheter already placed prior to the trial;
- Written informed consent obtained from the patient or their legal guardian.
Exclusion
- Age \<18 years;
- Pregnancy;
- Hemodynamic instability: Mean arterial pressure (MAP) \<60 mmHg, heart rate (HR) \>120 bpm or \<60 bpm;
- Respiratory instability: Respiratory rate (RR) \>35 bpm or oxygen saturation (SpO₂) \<90%;
- Neuromuscular disorders or phrenic nerve injury;
- Recent trauma or surgery involving the trachea, esophagus, neck, or thorax, contraindications to esophageal catheter insertion, or inability to monitor esophageal pressure;
- High bleeding risk: Severe coagulopathy/bleeding disorders, esophageal/gastric varices, etc.
Key Trial Info
Start Date :
May 20 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2025
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT06968793
Start Date
May 20 2025
End Date
December 30 2025
Last Update
May 22 2025
Active Locations (1)
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1
Beijing Shijitan Hospital
Beijing, Beijing Municipality, China, 100038