Status:
RECRUITING
Use of Nasal Pressure to Assess Inspiratory Effort Under Different Oxygen Treatments
Lead Sponsor:
Jian-Xin Zhou
Conditions:
Critical Care
Inspiratory Effort
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 ...
Detailed Description
Patients in the intensive care unit (ICU) often require different modalities of oxygen therapy to maintain adequate oxygenation.Common oxygen therapy modalities include nasal cannula oxygen, face mask...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 20 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2025
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT06970990
Start Date
May 20 2025
End Date
December 30 2025
Last Update
May 22 2025
Active Locations (1)
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1
Beijing Shijitan Hospital
Beijing, Beijing Municipality, China, 100038