Use of Endotracheal Tube Cuff Pressure to Assess Inspiratory Effort During Pressure Support Ventilation
1 other identifier
interventional
30
1 country
1
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2025
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 5, 2025
CompletedFirst Posted
Study publicly available on registry
May 13, 2025
CompletedStudy Start
First participant enrolled
May 20, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2025
CompletedJanuary 21, 2026
May 1, 2025
8 months
May 5, 2025
January 19, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Tidal swing of endotracheal tube cuff pressure (ΔPcuff)
Tidal swing of endotracheal tube cuff pressure (ΔPcuff) will be measured.
From enrollment to the end of treatment at 4 hours
Tidal swing of esophageal pressure (∆Pes)
Tidal swing of esophageal pressure (∆Pes) will be measured.
From enrollment to the end of treatment at 4 hours
Esophageal pressure-time product (PTP)
Esophageal pressure-time product (PTP) will be measured.
From enrollment to the end of treatment at 4 hours
Inspiratory muscle pressure (Pmus)
Inspiratory muscle pressure (Pmus) will be measured.
From enrollment to the end of treatment at 4 hours
Secondary Outcomes (2)
Occluded airway pressure at 100ms (P0.1)
From enrollment to the end of treatment at 4 hours
Maximal decrease of airway pressure during end-expiratory occlusion (∆Pocc)
From enrollment to the end of treatment at 4 hours
Study Arms (6)
Pressure support 15
EXPERIMENTALPressure support of 15 cm H2O will be applied for 5 minutes.
Pressure support 13
EXPERIMENTALPressure support of 13 cm H2O will be applied for 5 minutes.
Pressure support 11
EXPERIMENTALPressure support of 11 cm H2O will be applied for 5 minutes.
Pressure support 9
EXPERIMENTALPressure support of 9 cm H2O will be applied for 5 minutes.
Pressure support 7
EXPERIMENTALPressure support of 7 cm H2O will be applied for 5 minutes.
Pressure support 5
EXPERIMENTALPressure support of 5 cm H2O will be applied for 5 minutes.
Interventions
Pressure support of 13 cm H2O will be applied for 5 minutes.
Pressure support of 11 cm H2O will be applied for 5 minutes.
Pressure support of 7 cm H2O will be applied for 5 minutes.
Pressure support of 5 cm H2O will be applied for 5 minutes.
Pressure support of 15 cm H2O will be applied for 5 minutes.
Pressure support of 9 cm H2O will be applied for 5 minutes.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Jian-Xin Zhoulead
Study Sites (1)
Beijing Shijitan Hospital
Beijing, Beijing Municipality, 100038, China
Study Officials
- PRINCIPAL INVESTIGATOR
Jian-Xin Zhou, MD, PhD
Capital Medical University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Head of Emergency and Critical Care Center
Study Record Dates
First Submitted
May 5, 2025
First Posted
May 13, 2025
Study Start
May 20, 2025
Primary Completion
December 31, 2025
Study Completion
December 31, 2025
Last Updated
January 21, 2026
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will not share