Use of Nasal Pressure to Assess Inspiratory Effort Under Different Oxygen Treatments

NCT06970990 · tracked via the Priya Life Science China tracker

Sponsor

Jian-Xin Zhou

Phase

Not applicable

Started

2025-05-20

Last updated

2025-05-22

Condition(s) studied

Critical CareInspiratory Effort

Investigational drug(s) / intervention(s)

HFNC:50L/minHFNC:flow=40L/minHFNC:flow=30L/minFace mask oxygen:8L/minFace mask oxygen:5L/minNasal cannula oxygen:5L/minNasal cannula oxygen:3L/min

HFNC:50L/min: Under high-flow oxygen therapy at a flow rate of 50 L/min, record/monitor for 5 minutes

HFNC:flow=40L/min: Under high-flow oxygen therapy at a flow rate of 40 L/min, record/monitor for 5 minutes.

HFNC:flow=30L/min: Under high-flow oxygen therapy at a flow rate of 30 L/min, record/monitor for 5 minutes.

Face mask oxygen:8L/min: Under face mask oxygen at a flow rate of 8 L/min, record/monitor for 5 minutes.

Face mask oxygen:5L/min: Under face mask oxygen at a flow rate of 5 L/min, record/monitor for 5 minutes.

Nasal cannula oxygen:5L/min: Under nasal cannula oxygen at a flow rate of 5 L/min, record/monitor for 5 minutes.

Nasal cannula oxygen:3L/min: Under nasal cannula oxygen at a flow rate of 3 L/min, record/monitor for 5 minutes.

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: 1. No mechanical ventilation required,Able to tolerate oxygen therapy via nasal cannula, standard face mask, or nasal high-flow oxygen therapy; 2. 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; 3. 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); 4. Metabolic stability; 5. Compliance with medical instructions.Able to follow prescribed tasks.Esophageal pressure monitoring catheter already in place; 6. Patient or legal guardian agrees to participate and has signed the informed consent form. Exclusion Criteria: 1. Age \< 18 years; 2. Pregnancy; 3. Hemodynamic instability:Mean arterial pressure (MAP) \< 60 mmHg.Heart rate (HR) \> 120 bpm or \< 60 bpm; 4. Respiratory instability:Respiratory rate (RR) \> 35 bpm.Oxygen saturation (SpO₂) \< 90%; 5. Neuromuscular diseases or phrenic nerve injury; 6. Recent trauma or surgery involving the trachea, esophagus, neck, or chest.Contraindications to esophageal catheter placement or inability to monitor esophageal pressure; 7. 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; 8. 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; 9. Bleeding risk:Severe coagulopathy.Esophageal/gastric varices or other conditions predisposing to hemorrhage.

Primary outcome measure(s)

Tidal swing of nasal cuff pressure (ΔPnose) — 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) — From enrollment to the end of treatment at 4 hours
Tidal swing of esophageal pressure (∆Pes) will be measured

Trial sites (1)

Facility	City	Region	Status
Beijing Shijitan Hospital	Beijing	Beijing Municipality	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06970990 on ClinicalTrials.gov ↗ ← All trials in China