Use of Nasal Pressure to Assess Inspiratory Effort Under Different Oxygen Treatments
1 other identifier
interventional
26
1 country
1
Brief 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 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.
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 6, 2025
CompletedFirst Posted
Study publicly available on registry
May 14, 2025
CompletedStudy Start
First participant enrolled
May 20, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2025
CompletedMay 22, 2025
May 1, 2025
6 months
May 6, 2025
May 20, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Tidal swing of nasal cuff pressure (ΔPnose)
Tidal swing of nasal pressure (ΔPnose) 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
Secondary Outcomes (2)
Respiratory rate
From enrollment to the end of treatment at 4 hours.
COMFORT scale
From enrollment to the end of treatment at 4 hours
Study Arms (7)
HFNC:flow=50L/min
EXPERIMENTALUnder high-flow oxygen therapy at a flow rate of 50 L/min, record/monitor for 5 minutes
HFNC:flow=40L/min
EXPERIMENTALUnder high-flow oxygen therapy at a flow rate of 40 L/min, record/monitor for 5 minutes
HFNC:flow=30L/min
EXPERIMENTALUnder high-flow oxygen therapy at a flow rate of 30 L/min, record/monitor for 5 minutes
Face Mask Oxygen:8L/min
EXPERIMENTALUnder face mask oxygen at a flow rate of 8 L/min, record/monitor for 5 minutes.
Face Mask Oxygen:5L/min
EXPERIMENTALUnder face mask oxygen at a flow rate of 5 L/min, record/monitor for 5 minutes.
Nasal cannula oxygen:5L/min
EXPERIMENTALUnder nasal cannula oxygen at a flow rate of 5 L/min, record/monitor for 5 minutes.
Nasal cannula oxygen:3L/min
EXPERIMENTALUnder nasal cannula oxygen at a flow rate of 3 L/min, record/monitor for 5 minutes.
Interventions
Under high-flow oxygen therapy at a flow rate of 50 L/min, record/monitor for 5 minutes
Under high-flow oxygen therapy at a flow rate of 40 L/min, record/monitor for 5 minutes.
Under high-flow oxygen therapy at a flow rate of 30 L/min, record/monitor for 5 minutes.
Under face mask oxygen at a flow rate of 8 L/min, record/monitor for 5 minutes.
Under face mask oxygen at a flow rate of 5 L/min, record/monitor for 5 minutes.
Under nasal cannula oxygen at a flow rate of 5 L/min, record/monitor for 5 minutes.
Under nasal cannula oxygen at a flow rate of 3 L/min, record/monitor for 5 minutes.
Eligibility Criteria
You may qualify if:
- 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.
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.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;
- 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.
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
Central Study Contacts
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 6, 2025
First Posted
May 14, 2025
Study Start
May 20, 2025
Primary Completion
November 30, 2025
Study Completion
December 30, 2025
Last Updated
May 22, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will not share