Use of Endotracheal Tube Cuff Pressure to Assess Inspiratory Effort During Pressure Support Venti… (NCT06968793) | Clinical Trial Compass
CompletedNot Applicable
Use of Endotracheal Tube Cuff Pressure to Assess Inspiratory Effort During Pressure Support Ventilation
China30 participantsStarted 2025-05-20
Plain-language 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 mechanics.The aim of this study was to investigate the correlation between Cuff Pressure (Pcuff) and Esophageal Pressure in patients undergoing tracheal intubation or tracheotomy, and to assess whether Pcuff can be used as a surrogate for Pes for reflecting changes in intrathoracic pressure.The correlation and its consistency between the two under different ventilation conditions were analysed by synchronously monitoring the ΔPcuff and ΔPes to further validate the potential application value of cuff pressure in clinical practice.The results of the study will provide a more convenient and non-invasive method of monitoring intrathoracic pressure in mechanically ventilated patients, thus optimising ventilation strategies, reducing complications, and promoting the innovation and development of monitoring technology in the field of critical care medicine.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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 criteria
✕. Age \<18 years;
✕. Pregnancy;
✕. Hemodynamic instability: Mean arterial pressure (MAP) \<60 mmHg, heart rate (HR) \>120 bpm or \<60 bpm;
What they're measuring
1
Tidal swing of endotracheal tube cuff pressure (ΔPcuff)
Timeframe: From enrollment to the end of treatment at 4 hours
2
Tidal swing of esophageal pressure (∆Pes)
Timeframe: From enrollment to the end of treatment at 4 hours
3
Esophageal pressure-time product (PTP)
Timeframe: From enrollment to the end of treatment at 4 hours
4
Inspiratory muscle pressure (Pmus)
Timeframe: From enrollment to the end of treatment at 4 hours
✕. 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.