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