Critical CareNCT06970990
Use of Nasal Pressure to Assess Inspiratory Effort Under Different Oxygen Treatments
A study testing HFNC:50L/min, HFNC:flow=40L/min and HFNC:flow=30L/min in people with Critical Care and Inspiratory Effort, run by Jian-Xin Zhou at 1 site in China.
Trial summary
The aim of this study was to investigate the effects of different oxygen therapy modalities (including nasal cannula oxygen, mask oxygen and high-flow nasal cannula oxygen) on the correlation between Nasal Pressure and Esophageal Pressure by means of a prospective physiological study, to assess the dynamic changes of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Care, Inspiratory Effort
- What is being tested?
- HFNC:50L/min, HFNC:flow=40L/min and HFNC:flow=30L/min
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteChina
- Study dates
- 20 May 2025to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No mechanical ventilation required,Able to tolerate oxygen therapy via nasal cannula, standard face mask, or nasal high-flow oxygen therapy;
- Respiratory stability:Capable of spontaneous breathing with effective cough for secretion clearance.Oxygen saturation (SpO₂) > 90% or PaO₂/FiO₂ ≥ 150 mmHg when receiving nasal cannula oxygen at 3 L/min;
- Hemodynamic stability:Heart rate (HR) ≤ 120 bpm;Systolic blood pressure (SBP) 90-150 mmHg;No vasoactive medications OR norepinephrine dosage < 0.1-0.2 μg/kg·min (or equivalent doses of other vasoactive agents);
- Metabolic stability;
- Compliance with medical instructions.Able to follow prescribed tasks.Esophageal pressure monitoring catheter already in place;
- Patient or legal guardian agrees to participate and has signed the informed consent form.
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.Oxygen saturation (SpO₂) < 90%;
- Neuromuscular diseases or phrenic nerve injury;
- Recent trauma or surgery involving the trachea, esophagus, neck, or chest.Contraindications to esophageal catheter placement or inability to monitor esophageal pressure;
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- Nasal obstruction or anatomical abnormalities:Complete nasal obstruction.Severe anatomical abnormalities (e.g., severe septal deviation, nasal polyps, or tumors) preventing catheter placement or compromising ventilation;
- High-risk craniofacial conditions:Severe facial trauma or skull base fracture with risk of catheter misplacement into the intracranial space.Active epistaxis or incomplete healing after nasal surgery;
- Bleeding risk:Severe coagulopathy.Esophageal/gastric varices or other conditions predisposing to hemorrhage.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Rui-Zhi Zhang,MD contact
China1 site, 1 recruiting
- Recruiting
Beijing Shijitan Hospital
Beijing, Beijing Municipality, 100038
Jian-Xin Zhou, MD, PhD, +861063926666, zhoujx.cn@icloud.com
Rui-Zhi Zhang,MD, ifz0000@126.com
About this study
Official title: Use of Nasal Pressure to Assess Inspiratory Effort Under Different Oxygen Treatments: a Prospective Physiological Study
The aim of this study was to investigate the effects of different oxygen therapy modalities (including nasal cannula oxygen, mask oxygen and high-flow nasal cannula oxygen) on the correlation between Nasal Pressure and Esophageal Pressure by means of a prospective physiological study, to assess the dynamic changes of nasal pressure and esophageal pressure and their underlying mechanisms under different conditions of oxygen therapy, to analyse the effects of oxygen therapy parameters on the relationship between the two, and to explore the feasibility of nasal pressure as a non-invasive monitoring indicator, in order to replaceor supplement esophageal manometry in clinical practice, especially in patients with respiratory distress and instability.Meanwhile, this study will also evaluate the effects of different oxygen therapy modalities on patients' respiratory mechanics and comfort, provide a scientific basis for the clinical selection of individualised oxygen therapy regimens, and ultimately provide new physiological evidence for the management of oxygen therapy in patients with acute respiratory failure in the intensive care unit (ICU) and outside the ICU, promote the development of non-invasive monitoring technology, and improve the clinical prognosis and therapeutic experience of patients.
Read the detailed description
Patients in the intensive care unit (ICU) often require different modalities of oxygen therapy to maintain adequate oxygenation.Common oxygen therapy modalities include nasal cannula oxygen, face mask oxygen and high flow nasal cannula oxygen (HFNC).These modalities of oxygen therapy not only affect the patient's oxygenation status, but may also influence nasal and esophageal pressures by altering the upper airway pressure gradient, which in turn affects respiratory mechanics and patient comfort.
Esophageal pressure fluctuations (ΔPes), as a reflection of mean transpulmonary pressure during unassisted voluntary breathing, provide an important basis for assessing inspiratory effort.However, esophageal manometry still faces many challenges for its bedside implementation in clinical practice, especially in unstable patients with respiratory distress and severely impaired gas exchange.Notably, the COVID-19 pandemic has led to a significant increase in the number of patients with acute respiratory failure, who often require condition-specific oxygen therapy of varying severity and are mostly treated outside the ICU.Given that such patients are at high risk of deterioration, it is particularly important to continuously monitor their inspiratory effort.
nasal pressure is an important physiological indicator for assessing upper airway resistance and airflow dynamics characteristics, whereas esophageal pressure is a key parameter that directly reflects intrathoracic pressure and respiratory effort.Previous studies have shown that there may be a physiological correlation between intranasal pressure and oesophageal pressure, and that this correlation may be influenced by a variety of factors, including airflow velocity, oxygen concentration, and the dynamics of upper airway resistance.Earlier physiological studies by comparing oesophageal pressure fluctuations (ΔPes) with nasal pressure fluctuations (ΔPnose) fluctuations found that when inspiratory effort was increased, there was no significant phase difference between these pressure waveforms.In addition, it was observed that there was a significant correlation between ΔPes and airway pressure fluctuations (ΔPaw) obtained by airway occlusion manoeuvres during inspiratory effort testing.However, although these findings provide important clues for understanding respiratory mechanics, studies on the correlation between nasal pressure and esophageal pressure under different oxygen therapy conditions are still relatively limited, especially lacking data support from prospective physiological studies.Therefore, further systematic studies are needed in the future to investigate in depth the effects of different oxygen therapy parameters (e.g., flow rate, humidity, and temperature, etc.) on the relationship between nasal pressure and esophageal pressure, so as to provide more precise guidance for clinical practice.
- Conditions
- Critical Care, Inspiratory Effort
- Being tested
- HFNC:50L/min, HFNC:flow=40L/min, HFNC:flow=30L/min, Face mask oxygen:8L/min, Face mask oxygen:5L/min
- Keywords
- Esophageal pressure, inspiratory effort, oxygen treatments, Nasal Pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HFNC:50L/minProcedure or surgery
Under high-flow oxygen therapy at a flow rate of 50 L/min, record/monitor for 5 minutes
HFNC:flow=40L/minProcedure or surgery
Under high-flow oxygen therapy at a flow rate of 40 L/min, record/monitor for 5 minutes.
HFNC:flow=30L/minProcedure or surgery
Under high-flow oxygen therapy at a flow rate of 30 L/min, record/monitor for 5 minutes.
Face mask oxygen:8L/minProcedure or surgery
Under face mask oxygen at a flow rate of 8 L/min, record/monitor for 5 minutes.
Face mask oxygen:5L/minProcedure or surgery
Under face mask oxygen at a flow rate of 5 L/min, record/monitor for 5 minutes.
Nasal cannula oxygen:5L/minProcedure or surgery
Under nasal cannula oxygen at a flow rate of 5 L/min, record/monitor for 5 minutes.
Nasal cannula oxygen:3L/minProcedure or surgery
Under nasal cannula oxygen at a flow rate of 3 L/min, record/monitor for 5 minutes.
| Study group | Role | What they receive |
|---|---|---|
| HFNC:flow=50L/min | Experimental | Under high-flow oxygen therapy at a flow rate of 50 L/min, record/monitor for 5 minutes Receives: Procedure: HFNC:50L/min |
| HFNC:flow=40L/min | Experimental | Under high-flow oxygen therapy at a flow rate of 40 L/min, record/monitor for 5 minutes Receives: Procedure: HFNC:flow=40L/min |
| HFNC:flow=30L/min | Experimental | Under high-flow oxygen therapy at a flow rate of 30 L/min, record/monitor for 5 minutes Receives: Procedure: HFNC:flow=30L/min |
| Face Mask Oxygen:8L/min | Experimental | Under face mask oxygen at a flow rate of 8 L/min, record/monitor for 5 minutes. Receives: Procedure: Face mask oxygen:8L/min |
| Face Mask Oxygen:5L/min | Experimental | Under face mask oxygen at a flow rate of 5 L/min, record/monitor for 5 minutes. Receives: Procedure: Face mask oxygen:5L/min |
| Nasal cannula oxygen:5L/min | Experimental | Under nasal cannula oxygen at a flow rate of 5 L/min, record/monitor for 5 minutes. Receives: Procedure: Nasal cannula oxygen:5L/min |
| Nasal cannula oxygen:3L/min | Experimental | Under nasal cannula oxygen at a flow rate of 3 L/min, record/monitor for 5 minutes. Receives: Procedure: Nasal cannula oxygen:3L/min |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tidal swing of nasal cuff pressure (ΔPnose)
Tidal swing of nasal pressure (ΔPnose) 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
Secondary outcomes (2)
Respiratory rate
Respiratory rate will be measured at each type of oxygen treatment.
Measured: From enrollment to the end of treatment at 4 hours.
COMFORT scale
COMFORT scale 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 posted14 May 2025
- Study start20 May 2025
- Primary completion30 Nov 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical CareStudies 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
- 26 participants (estimated)
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
- NCT06970990
- Sponsor's protocol ID
- IIT2025-031-002
- Status last verified
- May 2025
- First submitted
- 6 May 2025
- Last updated
- 22 May 2025
- 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 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Nasal Pressure to Assess Inspiratory Effort Under Different Oxygen Treatments: a Prospective Physiological Study
- ClinicalTrials.gov ID
- NCT06970990
- Acronym / sponsor ID
- IIT2025-031-002
- Conditions
- Critical Care, Inspiratory Effort
- Keywords
- Esophageal pressure, inspiratory effort, oxygen treatments, Nasal Pressure
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Jian-Xin ZhouUniversity, hospital or other
- Study start
- 20 May 2025 (actual)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 14 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.
The aim of this study was to investigate the effects of different oxygen therapy modalities (including nasal cannula oxygen, mask oxygen and high-flow nasal cannula oxygen) on the correlation between Nasal Pressure and Esophageal Pressure by means of a prospective physiological study, to assess the dynamic changes of nasal pressure and esophageal pressure and their underlying mechanisms under different conditions of oxygen therapy, to analyse the effects of oxygen therapy parameters on the relationship between the two, and to explore the feasibility of nasal pressure as a non-invasive monitoring indicator, in order to replaceor supplement esophageal manometry in clinical practice, especially in patients with respiratory distress and instability.Meanwhile, this study will also evaluate the effects of different oxygen therapy modalities on patients' respiratory mechanics and comfort, provide a scientific basis for the clinical selection of individualised oxygen therapy regimens, and ultimately provide new physiological evidence for the management of oxygen therapy in patients with acute respiratory failure in the intensive care unit (ICU) and outside the ICU, promote the development of non-invasive monitoring technology, and improve the clinical prognosis and therapeutic experience of patients.
Detailed description
Patients in the intensive care unit (ICU) often require different modalities of oxygen therapy to maintain adequate oxygenation.Common oxygen therapy modalities include nasal cannula oxygen, face mask oxygen and high flow nasal cannula oxygen (HFNC).These modalities of oxygen therapy not only affect the patient's oxygenation status, but may also influence nasal and esophageal pressures by altering the upper airway pressure gradient, which in turn affects respiratory mechanics and patient comfort.
Esophageal pressure fluctuations (ΔPes), as a reflection of mean transpulmonary pressure during unassisted voluntary breathing, provide an important basis for assessing inspiratory effort.However, esophageal manometry still faces many challenges for its bedside implementation in clinical practice, especially in unstable patients with respiratory distress and severely impaired gas exchange.Notably, the COVID-19 pandemic has led to a significant increase in the number of patients with acute respiratory failure, who often require condition-specific oxygen therapy of varying severity and are mostly treated outside the ICU.Given that such patients are at high risk of deterioration, it is particularly important to continuously monitor their inspiratory effort.
nasal pressure is an important physiological indicator for assessing upper airway resistance and airflow dynamics characteristics, whereas esophageal pressure is a key parameter that directly reflects intrathoracic pressure and respiratory effort.Previous studies have shown that there may be a physiological correlation between intranasal pressure and oesophageal pressure, and that this correlation may be influenced by a variety of factors, including airflow velocity, oxygen concentration, and the dynamics of upper airway resistance.Earlier physiological studies by comparing oesophageal pressure fluctuations (ΔPes) with nasal pressure fluctuations (ΔPnose) fluctuations found that when inspiratory effort was increased, there was no significant phase difference between these pressure waveforms.In addition, it was observed that there was a significant correlation between ΔPes and airway pressure fluctuations (ΔPaw) obtained by airway occlusion manoeuvres during inspiratory effort testing.However, although these findings provide important clues for understanding respiratory mechanics, studies on the correlation between nasal pressure and esophageal pressure under different oxygen therapy conditions are still relatively limited, especially lacking data support from prospective physiological studies.Therefore, further systematic studies are needed in the future to investigate in depth the effects of different oxygen therapy parameters (e.g., flow rate, humidity, and temperature, etc.) on the relationship between nasal pressure and esophageal pressure, so as to provide more precise guidance for clinical practice.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| HFNC:flow=50L/min | Experimental | Procedure: HFNC:50L/minUnder high-flow oxygen therapy at a flow rate of 50 L/min, record/monitor for 5 minutes |
| HFNC:flow=40L/min | Experimental | Procedure: HFNC:flow=40L/minUnder high-flow oxygen therapy at a flow rate of 40 L/min, record/monitor for 5 minutes |
| HFNC:flow=30L/min | Experimental | Procedure: HFNC:flow=30L/minUnder high-flow oxygen therapy at a flow rate of 30 L/min, record/monitor for 5 minutes |
| Face Mask Oxygen:8L/min | Experimental | Procedure: Face mask oxygen:8L/minUnder face mask oxygen at a flow rate of 8 L/min, record/monitor for 5 minutes. |
| Face Mask Oxygen:5L/min | Experimental | Procedure: Face mask oxygen:5L/minUnder face mask oxygen at a flow rate of 5 L/min, record/monitor for 5 minutes. |
| Nasal cannula oxygen:5L/min | Experimental | Procedure: Nasal cannula oxygen:5L/minUnder nasal cannula oxygen at a flow rate of 5 L/min, record/monitor for 5 minutes. |
| Nasal cannula oxygen:3L/min | Experimental | Procedure: Nasal cannula oxygen:3L/minUnder nasal cannula oxygen at a flow rate of 3 L/min, record/monitor 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 (6 listed)
- No mechanical ventilation required,Able to tolerate oxygen therapy via nasal cannula, standard face mask, or nasal high-flow oxygen therapy;
- Respiratory stability:Capable of spontaneous breathing with effective cough for secretion clearance.Oxygen saturation (SpO₂) > 90% or PaO₂/FiO₂ ≥ 150 mmHg when receiving nasal cannula oxygen at 3 L/min;
- Hemodynamic stability:Heart rate (HR) ≤ 120 bpm;Systolic blood pressure (SBP) 90-150 mmHg;No vasoactive medications OR norepinephrine dosage < 0.1-0.2 μg/kg·min (or equivalent doses of other vasoactive agents);
- Metabolic stability;
- Compliance with medical instructions.Able to follow prescribed tasks.Esophageal pressure monitoring catheter already in place;
Key exclusion criteria (9 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.Oxygen saturation (SpO₂) < 90%;
- Neuromuscular diseases 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 |
|---|---|---|
| HFNC:50L/minUnder high-flow oxygen therapy at a flow rate of 50 L/min, record/monitor for 5 minutes | Procedure or surgery | HFNC:flow=50L/min |
| HFNC:flow=40L/minUnder high-flow oxygen therapy at a flow rate of 40 L/min, record/monitor for 5 minutes. | Procedure or surgery | HFNC:flow=40L/min |
| HFNC:flow=30L/minUnder high-flow oxygen therapy at a flow rate of 30 L/min, record/monitor for 5 minutes. | Procedure or surgery | HFNC:flow=30L/min |
| Face mask oxygen:8L/minUnder face mask oxygen at a flow rate of 8 L/min, record/monitor for 5 minutes. | Procedure or surgery | Face Mask Oxygen:8L/min |
| Face mask oxygen:5L/minUnder face mask oxygen at a flow rate of 5 L/min, record/monitor for 5 minutes. | Procedure or surgery | Face Mask Oxygen:5L/min |
| Nasal cannula oxygen:5L/minUnder nasal cannula oxygen at a flow rate of 5 L/min, record/monitor for 5 minutes. | Procedure or surgery | Nasal cannula oxygen:5L/min |
| Nasal cannula oxygen:3L/minUnder nasal cannula oxygen at a flow rate of 3 L/min, record/monitor for 5 minutes. | Procedure or surgery | Nasal cannula oxygen:3L/min |
Primary outcome
Tidal swing of nasal cuff pressure (ΔPnose)
Time frame: From enrollment to the end of treatment at 4 hours
Tidal swing of nasal pressure (ΔPnose) 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
2 secondary outcomes
Respiratory rate
Time frame: From enrollment to the end of treatment at 4 hours.
COMFORT scale
Time frame: From enrollment to the end of treatment at 4 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2025.
- 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.
Rui-Zhi Zhang,MD contact
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 HFNC:50L/min, HFNC:flow=40L/min and HFNC:flow=30L/min in people with Critical Care and Inspiratory Effort, 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 6 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 22 May 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jian-Xin Zhou, MD, PhD (8610 6392 6666, zhoujx.cn@icloud.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tidal swing of nasal cuff pressure (ΔPnose) (time frame: From enrollment to the end of treatment at 4 hours). The study lists 2 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 22 May 2025.