Assessing breathing effort with nasal pressure during different oxygen treatments

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: zhoujx.cn@icloud.com
• Phone: 8610 6392 6666

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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  Recruiting Mahidol University · Bangkok, Bangkoknoi · NCT07199881

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.