Mechanical VentilationNCT06968793
Use of Endotracheal Tube Cuff Pressure to Assess Inspiratory Effort During Pressure Support Ventilation
A study testing Pressure support 15, Pressure support 13 and Pressure support 11 in people with Mechanical Ventilation and Critical Care, run by Jian-Xin Zhou at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mechanical Ventilation, Critical Care, Inspiratory Effort
- What is being tested?
- Pressure support 15, Pressure support 13 and Pressure support 11
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 20 May 2025to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of Endotracheal Tube Cuff Pressure to Assess Inspiratory Effort During Pressure Support Ventilation: a Prospective Physiological Study
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.
Read the 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 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.
- Conditions
- Mechanical Ventilation, Critical Care, Inspiratory Effort
- Being tested
- Pressure support 15, Pressure support 13, Pressure support 11, Pressure support 9, Pressure support 7
- Keywords
- Esophageal pressure, mechanical ventilation, Endotracheal tube cuff pressure, inspiratory effort
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pressure support 15Procedure or surgery
Pressure support of 15 cm H2O will be applied for 5 minutes.
Pressure support 13Procedure or surgery
Pressure support of 13 cm H2O will be applied for 5 minutes.
Pressure support 11Procedure or surgery
Pressure support of 11 cm H2O will be applied for 5 minutes.
Pressure support 9Procedure or surgery
Pressure support of 9 cm H2O will be applied for 5 minutes.
Pressure support 7Procedure or surgery
Pressure support of 7 cm H2O will be applied for 5 minutes.
Pressure support 5Procedure or surgery
Pressure support of 5 cm H2O will be applied for 5 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Pressure support 15 | Experimental | Pressure support of 15 cm H2O will be applied for 5 minutes. Receives: Procedure: Pressure support 15 |
| Pressure support 13 | Experimental | Pressure support of 13 cm H2O will be applied for 5 minutes. Receives: Procedure: Pressure support 13 |
| Pressure support 11 | Experimental | Pressure support of 11 cm H2O will be applied for 5 minutes. Receives: Procedure: Pressure support 11 |
| Pressure support 9 | Experimental | Pressure support of 9 cm H2O will be applied for 5 minutes. Receives: Procedure: Pressure support 9 |
| Pressure support 7 | Experimental | Pressure support of 7 cm H2O will be applied for 5 minutes. Receives: Procedure: Pressure support 7 |
| Pressure support 5 | Experimental | Pressure support of 5 cm H2O will be applied for 5 minutes. Receives: Procedure: Pressure support 5 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tidal swing of endotracheal tube cuff pressure (ΔPcuff)
Tidal swing of endotracheal tube cuff pressure (ΔPcuff) will be measured.
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.
Measured: From enrollment to the end of treatment at 4 hours
Esophageal pressure-time product (PTP)
Esophageal pressure-time product (PTP) will be measured.
Measured: From enrollment to the end of treatment at 4 hours
Inspiratory muscle pressure (Pmus)
Inspiratory muscle pressure (Pmus) will be measured.
Measured: From enrollment to the end of treatment at 4 hours
Secondary outcomes (2)
Occluded airway pressure at 100ms (P0.1)
Occluded airway pressure at 100ms (P0.1) will be measured.
Measured: From enrollment to the end of treatment at 4 hours
Maximal decrease of airway pressure during end-expiratory occlusion (∆Pocc)
Maximal decrease of airway pressure during end-expiratory occlusion (∆Pocc) will be measured
Measured: From enrollment to the end of treatment at 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2025
- Study start20 May 2025
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical VentilationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jian-Xin Zhou
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jian-Xin Zhou, Capital Medical University
- Investigators
- Jian-Xin Zhou, MD, PhD, Principal investigator, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06968793
- Sponsor's protocol ID
- IIT2025-034-002
- Status last verified
- May 2025
- First submitted
- 5 May 2025
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Endotracheal Tube Cuff Pressure to Assess Inspiratory Effort During Pressure Support Ventilation: a Prospective Physiological Study
- ClinicalTrials.gov ID
- NCT06968793
- Acronym / sponsor ID
- IIT2025-034-002
- Conditions
- Mechanical Ventilation, Critical Care, Inspiratory Effort
- Keywords
- Esophageal pressure, mechanical ventilation, Endotracheal tube cuff pressure, inspiratory effort
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Jian-Xin ZhouUniversity, hospital or other
- Study start
- 20 May 2025 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 13 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Pressure support 15 | Experimental | Procedure: Pressure support 15Pressure support of 15 cm H2O will be applied for 5 minutes. |
| Pressure support 13 | Experimental | Procedure: Pressure support 13Pressure support of 13 cm H2O will be applied for 5 minutes. |
| Pressure support 11 | Experimental | Procedure: Pressure support 11Pressure support of 11 cm H2O will be applied for 5 minutes. |
| Pressure support 9 | Experimental | Procedure: Pressure support 9Pressure support of 9 cm H2O will be applied for 5 minutes. |
| Pressure support 7 | Experimental | Procedure: Pressure support 7Pressure support of 7 cm H2O will be applied for 5 minutes. |
| Pressure support 5 | Experimental | Procedure: Pressure support 5Pressure support of 5 cm H2O will be applied for 5 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pressure support 15Pressure support of 15 cm H2O will be applied for 5 minutes. | Procedure or surgery | Pressure support 15 |
| Pressure support 13Pressure support of 13 cm H2O will be applied for 5 minutes. | Procedure or surgery | Pressure support 13 |
| Pressure support 11Pressure support of 11 cm H2O will be applied for 5 minutes. | Procedure or surgery | Pressure support 11 |
| Pressure support 9Pressure support of 9 cm H2O will be applied for 5 minutes. | Procedure or surgery | Pressure support 9 |
| Pressure support 7Pressure support of 7 cm H2O will be applied for 5 minutes. | Procedure or surgery | Pressure support 7 |
| Pressure support 5Pressure support of 5 cm H2O will be applied for 5 minutes. | Procedure or surgery | Pressure support 5 |
Primary outcome
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.
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.
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.
Inspiratory muscle pressure (Pmus)
Time frame: From enrollment to the end of treatment at 4 hours
Inspiratory muscle pressure (Pmus) will be measured.
2 secondary outcomes
Occluded airway pressure at 100ms (P0.1)
Time frame: From enrollment to the end of treatment at 4 hours
Maximal decrease of airway pressure during end-expiratory occlusion (∆Pocc)
Time frame: From enrollment to the end of treatment at 4 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jian-Xin Zhou, MD, PhD principal investigator
Capital Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pressure support 15, Pressure support 13 and Pressure support 11 in people with Mechanical Ventilation and Critical Care, run by Jian-Xin Zhou at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tidal swing of endotracheal tube cuff pressure (ΔPcuff) (time frame: From enrollment to the end of treatment at 4 hours). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.