Use of Nasal Pressure to Assess Inspiratory Effort Under Different Oxygen Treatments
Use of Nasal Pressure to Assess Inspiratory Effort Under Different Oxygen Treatments: a Prospective Physiological Study
Jian-Xin Zhou
26 participants
May 20, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria6
- 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.
Exclusion Criteria9
- 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.
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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.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06970990