Observing exhaled nitric oxide levels in ICU patients with respiratory failure
Official title: An Observational Study of Fractional Exhaled Nitric Oxide Concentration in Patients With Advanced Respiratory Support
Run by Shanghai Zhongshan Hospital · NCT06680895 · Data updated 2026-11-12
This study looks at the levels of a gas called nitric oxide in the breath of ICU patients with breathing problems to see how it changes over time and how it relates to their treatment.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 1000 (estimated) |
| Sponsor | Shanghai Zhongshan Hospital Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Status | Recruiting |
| Started | July 1, 2024 |
| Main results expected | September 30, 2025 |
| Study ends | December 31, 2025 |
| Registry record updated | November 8, 2024 |
| Trial ID | NCT06680895 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adult patients aged 18 and older who are on mechanical ventilation or advanced respiratory support in the ICU.
✕Probably not a fit
Patients who have used NO-containing drugs or anti-inflammatory medications within 6 hours prior to the first FeNO measurement may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to compare the concentration of exhaled nitric oxide (FeNO) in patients with varying severity of respiratory failure in the ICU. It will monitor changes in FeNO levels over time in patients receiving mechanical ventilation and explore the relationship between these levels and pulmonary blood flow. Additionally, the study will assess how patients with different FeNO concentrations respond to inhaled nitric oxide therapy. The methodology involves measuring FeNO in adult patients who are on mechanical ventilation for more than 24 hours.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of respiratory failure management and improve therapeutic strategies for patients in the ICU.
How similar studies have gone: While this approach is observational, similar studies have shown promise in understanding nitric oxide's role in respiratory conditions, suggesting potential for valuable insights.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Adult patients (≥18 years of age) with mechanical ventilation or advanced respiratory support in the ICU, regardless of gender; 2. The expected mechanical ventilation time of tracheal intubation is more than 24 hours; 3. The initial ventilator Settings of clinical routine were adopted: oxygen fraction (FIO2) = 50%, respiratory rate = 15/min, positive end-expiratory pressure (PEEP) = 5 cmH2O, tidal volume = 6-8 ml/kg ideal body weight (IBW), inspiration-exhalation ratio =1:2; 4. Agree to participate in this experiment and sign the informed consent. Exclusion Criteria: * 1.Use of any NO-containing drugs (such as nitroglycerin), anti-inflammatory drugs, or drugs or means that affect the airway diameter within 6 hours before the first FeNO measurement; 2. Participating in other clinical research projects; 3. Patients deemed unsuitable by the investigators.
Where it's running
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Shanghai Zhongshan hospital
Shanghai, Shanghai Municipality, China Recruiting
Study contacts
- Study coordinator: Huan Wang, Master
- Email: wang.huan@zs-hospital.sh.cn
- Phone: 13472735075
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.