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Evaluation of the therapeutic effect of awake prone position combined with inhaled nitric oxide in non-intubated ARDS patients: a single arm clinical trial

Evaluation of the therapeutic effect of awake prone position combined with inhaled nitric oxide in non-intubated ARDS patients: a single arm clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500107210
Enrollment
Unknown
Registered
2025-08-06
Start date
2025-09-01
Completion date
Unknown
Last updated
2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute respiratory distress syndrome

Interventions

Experimental group:Nitric oxide and conscious prone position treatment alone or in combination

Sponsors

Zhongshan Hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age >=18 years old, gender is not limited; 2. Patients with spontaneous breathing and clear consciousness can cooperate with breath hold for 5 seconds; 3. Non-invasive ventilation with PEEP or CPAP>=5mmHg or high-flow oxygen therapy with a flow rate >=30L/min, which meets the new global diagnostic criteria for non-intubated ARDS: PaO2/FiO2<=300mmHg or SpO2/FiO2<=315 (SpO2<=97%); 4. Patients or their families agree to participate in this trial and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Respiratory fatigue symptoms: RR>40/min, PaCO2>50mmHg/pH<7.30, and obvious use of auxiliary respiratory muscles; 2. Patients in urgent need of intubation (PaO2/FiO2<50 mmHg, unable to protect the airway or change mental status); 3. Hemodynamic instability, i.e., an increase of more than 30% of vasoactive drugs within 6 hours, or a dose of norepinephrine more than 0.5mcg/kg/min; 4. Contraindications to EIT monitoring, such as implantation of a pacemaker; 5. Patients who cannot perform awake prone position after severe facial trauma, severe chest and abdominal trauma, unfixed fractures, etc.; 6. Patients with chronic obstructive pulmonary disease, pulmonary embolism or pulmonary fibrosis; 7. Patients with intracranial hypertension, severe arrhythmia or gastrointestinal obstruction; 8. Pregnant or lactating; 9. Need to receive extracorporeal membrane oxygenation therapy; 10. Patients who are participating in other studies. The experimental protocol is approved by the ethics committee, and the patient or his client signs the informed consent form; 11. Other conditions in which the clinician believes that the patient is not suitable for inclusion in the study.

Design outcomes

Primary

MeasureTime frame
Oxygenation index;

Countries

China

Contacts

Public ContactLiu Kai

Zhongshan Hospital Affiliated to Fudan University

Liu.kai1@zs-hospital.sh.cn+86 135 1213 6346

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026