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Search / Trial NCT06968793

Use of Endotracheal Tube Cuff Pressure to Assess Inspiratory Effort During Pressure Support Ventilation

Launched by JIAN-XIN ZHOU · May 5, 2025

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Esophageal Pressure Mechanical Ventilation Endotracheal Tube Cuff Pressure Inspiratory Effort

ClinConnect Summary

This clinical trial is studying how the pressure in the cuff of an endotracheal tube (the tube placed in a patient's windpipe to help them breathe) relates to the pressure inside the esophagus during a specific type of breathing support called pressure support ventilation (PSV). The researchers want to see if measuring the cuff pressure can provide a simple and non-invasive way to understand changes in breathing pressure for patients on mechanical ventilation. This could help doctors manage ventilation better, reduce complications, and improve care for critically ill patients.

To participate in the trial, patients must be between 65 and 74 years old, be stable enough to breathe on their own while receiving PSV, and have certain health conditions under control. They should also be able to cough effectively and have a specific level of oxygen in their blood. Patients who are pregnant, under 18, or have significant heart or breathing problems may not be eligible. If someone is chosen for the study, they will have their cuff pressure and esophageal pressure monitored closely to gather important data while receiving their usual care.

Gender

ALL

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.

About Jian Xin Zhou

Jian-Xin Zhou is a dedicated clinical trial sponsor committed to advancing medical research and innovation. With a focus on developing effective therapies across various therapeutic areas, the organization emphasizes rigorous scientific methodologies and ethical standards in all its studies. Jian-Xin Zhou collaborates with leading researchers and institutions to ensure the highest quality of clinical trials, aiming to bring breakthrough treatments to patients while prioritizing safety and efficacy. Through its strategic approach and commitment to excellence, Jian-Xin Zhou strives to make significant contributions to the healthcare landscape.

Locations

Beijing, Beijing, China

Patients applied

0 patients applied

Trial Officials

Jian-Xin Zhou, MD, PhD

Principal Investigator

Capital Medical University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported