Use of Nasal Pressure to Assess Inspiratory Effort Under Different Oxygen Treatments
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorJian-Xin Zhou
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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%;
Trial design
Design model
Crossover
Treatments tested in this trial
HFNC:50L/min
Procedure/SurgeryUnder high-flow oxygen therapy at a flow rate of 50 L/min, record/monitor for 5 minutes
HFNC:flow=40L/min
Procedure/SurgeryUnder high-flow oxygen therapy at a flow rate of 40 L/min, record/monitor for 5 minutes.
HFNC:flow=30L/min
Procedure/SurgeryUnder high-flow oxygen therapy at a flow rate of 30 L/min, record/monitor for 5 minutes.
Face mask oxygen:8L/min
Procedure/SurgeryUnder face mask oxygen at a flow rate of 8 L/min, record/monitor for 5 minutes.
Face mask oxygen:5L/min
Procedure/SurgeryUnder face mask oxygen at a flow rate of 5 L/min, record/monitor for 5 minutes.
Nasal cannula oxygen:5L/min
Procedure/SurgeryUnder nasal cannula oxygen at a flow rate of 5 L/min, record/monitor for 5 minutes.
Nasal cannula oxygen:3L/min
Procedure/SurgeryUnder nasal cannula oxygen at a flow rate of 3 L/min, record/monitor for 5 minutes.
Treatment groups
26 Participants
are divided into 7 treatment groups7
Treatment groupsSee each treatment group below.
Group A: HFNC:flow=50L/minExperimental treatment 1 intervention
Group B: HFNC:flow=40L/minExperimental treatment 1 intervention
Group C: HFNC:flow=30L/minExperimental treatment 1 intervention
Group D: Face Mask Oxygen:8L/minExperimental treatment 1 intervention
Group E: Face Mask Oxygen:5L/minExperimental treatment 1 intervention
Group F: Nasal cannula oxygen:5L/minExperimental treatment 1 intervention
Group G: Nasal cannula oxygen:3L/minExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Tidal swing of nasal cuff pressure (ΔPnose)
Tidal swing of nasal pressure (ΔPnose) will be measured
Time frame
From enrollment to the end of treatment at 4 hours2
Tidal swing of esophageal pressure (∆Pes)
Tidal swing of esophageal pressure (∆Pes) will be measured
Time frame
From enrollment to the end of treatment at 4 hoursSecondary outcomes
1
Respiratory rate
Respiratory rate will be measured at each type of oxygen treatment.
Time frame
From enrollment to the end of treatment at 4 hours.2
COMFORT scale
COMFORT scale will be measured
Time frame
From enrollment to the end of treatment at 4 hoursSponsors and contacts
Click on the lead sponsor to view all of their trials.
Jian-Xin Zhou
Lead sponsor
Capital Medical University
Sponsor institution
Source ClinicalTrials.gov