Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06970990

Use of Nasal Pressure to Assess Inspiratory Effort Under Different Oxygen Treatments

Led by Jian-Xin Zhou · Updated on 2025-05-22

26

Participants Needed

1

Research Sites

32 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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 Nasal Pressure and Esophageal Pressure by means of a prospective physiological study, to assess the dynamic changes of nasal pressure and esophageal pressure and their underlying mechanisms under different conditions of oxygen therapy, to analyse the effects of oxygen therapy parameters on the relationship between the two, and to explore the feasibility of nasal pressure as a non-invasive monitoring indicator, in order to replaceor supplement esophageal manometry in clinical practice, especially in patients with respiratory distress and instability.Meanwhile, this study will also evaluate the effects of different oxygen therapy modalities on patients' respiratory mechanics and comfort, provide a scientific basis for the clinical selection of individualised oxygen therapy regimens, and ultimately provide new physiological evidence for the management of oxygen therapy in patients with acute respiratory failure in the intensive care unit (ICU) and outside the ICU, promote the development of non-invasive monitoring technology, and improve the clinical prognosis and therapeutic experience of patients.

CONDITIONS

Official Title

Use of Nasal Pressure to Assess Inspiratory Effort Under Different Oxygen Treatments

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • No mechanical ventilation required and able to tolerate oxygen therapy via nasal cannula, standard face mask, or nasal high-flow oxygen therapy
  • Respiratory stability with spontaneous breathing and effective cough for secretion clearance
  • Oxygen saturation (SpO2) greater than 90% or PaO2/FiO2 at least 150 mmHg when receiving nasal cannula oxygen at 3 L/min
  • Hemodynamic stability with heart rate less than or equal to 120 bpm and systolic blood pressure between 90 and 150 mmHg
  • No vasoactive medications or norepinephrine dosage less than 0.1-0.2 µg/kg·min (or equivalent doses of other vasoactive agents)
  • Metabolic stability
  • Able to follow medical instructions and perform prescribed tasks
  • Esophageal pressure monitoring catheter already in place
  • Patient or legal guardian agrees to participate and has signed informed consent form
Not Eligible

You will not qualify if you...

  • Age less than 18 years
  • Pregnancy
  • Hemodynamic instability with mean arterial pressure less than 60 mmHg or heart rate greater than 120 bpm or less than 60 bpm
  • Respiratory instability with respiratory rate greater than 35 bpm or oxygen saturation less than 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
  • Complete nasal obstruction or severe nasal anatomical abnormalities preventing catheter placement or ventilation
  • Severe facial trauma, skull base fracture, active nosebleeds, or incomplete healing after nasal surgery
  • Severe bleeding risk such as coagulopathy or esophageal/gastric varices

AI-Screening

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Trial Site Locations

Total: 1 location

1

Beijing Shijitan Hospital

Beijing, Beijing Municipality, China, 100038

Actively Recruiting

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Research Team

J

Jian-Xin Zhou, MD, PhD

CONTACT

R

Rui-Zhi Zhang,MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

7

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