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Completed

NCT Number: NCT06968793

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Shijitan Hospital

Beijing, Beijing Municipality, 100038, China

About this study

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 indirect information about pleural pressure, which is critical for understanding respiratory mechanics, optimizing mechanical ventilation strategies, and evaluating respiratory muscle load.

However, despite its clinical significance, Esophageal pressure monitoring involves a relatively complex and invasive procedure. Measurement typically requires the insertion of an esophageal catheter via the nasopharyngeal or oropharyngeal route, which may cause patient discomfort and prove challenging in certain cases (e.g., esophageal pathologies or anatomical abnormalities). Consequently, while esophageal pressure remains the current gold standard for evaluating intrathoracic pressure, its clinical application faces limitations.

In contrast, Cuff pressure (Pcuff) monitoring in intubated or tracheostomized patients is simpler and routinely performed. Cuff pressure measurement primarily ensures tracheal tube sealing to prevent gas leakage and aspiration, while also reducing the risk of ventilator-associated pneumonia (VAP). Our preliminary exploratory studies have revealed correlations between Cuff pressure fluctuations and Esophageal pressure, particularly in patients undergoing pressure support ventilation. This finding suggests the potential utility of Cuff pressure as a surrogate marker for intrathoracic pressure. Esophageal pressure inherently reflects pleural pressure through Esophageal pressure changes, while the artificial airway cuff-positioned above the carina within the trachea-detects subtle pressure variations induced by adjacent muscle activity during forceful breathing. These measurements may indirectly indicate inspiratory effort. Variations in cuff positioning might influence results, and our exploratory attempts demonstrated strong waveform correlations between Cuff pressure and Esophageal pressure.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;
  • 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.

Treatment and study plan

Pressure support 15

Procedure

Pressure support of 15 cm H2O will be applied for 5 minutes.

Pressure support 13

Procedure

Pressure support of 13 cm H2O will be applied for 5 minutes.

Pressure support 11

Procedure

Pressure support of 11 cm H2O will be applied for 5 minutes.

Pressure support 9

Procedure

Pressure support of 9 cm H2O will be applied for 5 minutes.

Pressure support 7

Procedure

Pressure support of 7 cm H2O will be applied for 5 minutes.

Pressure support 5

Procedure

Pressure support of 5 cm H2O will be applied for 5 minutes.

Primary outcomes

  1. Tidal swing of endotracheal tube cuff pressure (ΔPcuff)

    Time frame: From enrollment to the end of treatment at 4 hours

    Tidal swing of endotracheal tube cuff pressure (ΔPcuff) will be measured.

  2. Tidal swing of esophageal pressure (∆Pes)

    Time frame: From enrollment to the end of treatment at 4 hours

    Tidal swing of esophageal pressure (∆Pes) will be measured.

  3. Esophageal pressure-time product (PTP)

    Time frame: From enrollment to the end of treatment at 4 hours

    Esophageal pressure-time product (PTP) will be measured.

  4. Inspiratory muscle pressure (Pmus)

    Time frame: From enrollment to the end of treatment at 4 hours

    Inspiratory muscle pressure (Pmus) will be measured.

Secondary outcomes

  1. Occluded airway pressure at 100ms (P0.1)

    Time frame: From enrollment to the end of treatment at 4 hours

    Occluded airway pressure at 100ms (P0.1) will be measured.

  2. Maximal decrease of airway pressure during end-expiratory occlusion (∆Pocc)

    Time frame: From enrollment to the end of treatment at 4 hours

    Maximal decrease of airway pressure during end-expiratory occlusion (∆Pocc) will be measured

Sponsors and collaborators

Lead sponsor

Jian-Xin Zhou

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 13, 2025
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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