Observing exhaled nitric oxide levels in ICU patients with respiratory failure
An Observational Study of Fractional Exhaled Nitric Oxide Concentration in Patients With Advanced Respiratory Support
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 |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Shanghai Zhongshan Hospital Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT06680895 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adult patients aged 18 and older who are on mechanical ventilation or advanced respiratory support in the ICU.
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.
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 performed: While this approach is observational, similar studies have shown promise in understanding nitric oxide's role in respiratory conditions, suggesting potential for valuable insights.
Eligibility criteria
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 this trial is running
Shanghai, Shanghai Municipality
- 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 participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.