Use of Nasal Pressure to Assess Inspiratory Effort Under Different Oxygen Treatments
Launched by JIAN-XIN ZHOU · May 6, 2025
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying how different types of oxygen treatments, like nasal cannulas, masks, and high-flow nasal cannulas, affect breathing effort in patients who are having trouble breathing. Researchers want to see if measuring pressure in the nose can help us understand how much effort a person is using to breathe compared to a more invasive method of measuring pressure in the esophagus. The goal is to find out if nasal pressure can be a simpler and safer way to monitor patients, especially those in critical care settings, and to improve their comfort and treatment outcomes.
To participate in the trial, individuals must be between the ages of 18 and 74, be able to breathe on their own without needing a breathing machine, and have stable heart and blood pressure. They also need to be able to follow medical instructions and provide consent to join the study. If eligible, participants can expect to undergo some monitoring while receiving different types of oxygen therapy, and their breathing mechanics and comfort will be evaluated. This research aims to enhance how we manage oxygen therapy in patients with serious breathing issues, potentially benefiting those in both the intensive care unit and other care settings.
Gender
ALL
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.
About Jian Xin Zhou
Jian-Xin Zhou is a dedicated clinical trial sponsor committed to advancing medical research and innovation. With a focus on developing effective therapies across various therapeutic areas, the organization emphasizes rigorous scientific methodologies and ethical standards in all its studies. Jian-Xin Zhou collaborates with leading researchers and institutions to ensure the highest quality of clinical trials, aiming to bring breakthrough treatments to patients while prioritizing safety and efficacy. Through its strategic approach and commitment to excellence, Jian-Xin Zhou strives to make significant contributions to the healthcare landscape.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Beijing, Beijing, China
Patients applied
Trial Officials
Jian-Xin Zhou, MD, PhD
Principal Investigator
Capital Medical University
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported