Assessing breathing effort with nasal pressure during different oxygen treatments

Use of Nasal Pressure to Assess Inspiratory Effort Under Different Oxygen Treatments: a Prospective Physiological Study

This study is testing if measuring nasal pressure can help doctors understand how hard patients with breathing problems are working to breathe when using different types of oxygen therapy.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 26 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Capital Medical University (other)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06970990 on ClinicalTrials.gov

What this trial studies

This study investigates how various oxygen therapy methods, such as nasal cannula and high-flow nasal cannula, affect the relationship between nasal pressure and esophageal pressure in patients with respiratory distress. By monitoring these pressures, the study aims to evaluate the feasibility of using nasal pressure as a non-invasive indicator for assessing inspiratory effort, potentially replacing esophageal manometry in clinical settings. The research will also analyze the impact of different oxygen therapies on respiratory mechanics and patient comfort, providing insights for personalized oxygen treatment regimens.

Who should consider this trial

Good fit: Ideal candidates include adults in the ICU who are stable enough to tolerate various forms of oxygen therapy without requiring mechanical ventilation.

Not a fit: Patients who are hemodynamically unstable or require mechanical ventilation will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved non-invasive monitoring of respiratory effort in critically ill patients, enhancing their treatment and comfort.

How similar studies have performed: While the approach of using nasal pressure for monitoring is promising, it is relatively novel and has not been extensively tested in similar studies.

Eligibility criteria

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.

Where this trial is running

Beijing, Beijing Municipality

• Beijing Shijitan Hospital — Beijing, Beijing Municipality, China (RECRUITING)

Study contacts

• Principal investigator: Jian-Xin Zhou, MD, PhD — Capital Medical University
• Study coordinator: Jian-Xin Zhou, MD, PhD

Conditions: Critical Care, Inspiratory Effort, Esophageal pressure, inspiratory effort, oxygen treatments, Nasal Pressure