Using inhaled nitric oxide to improve lung function after heart surgery
Role of Inhaled Nitric Oxide in Vascular Mechanics and Right Ventricular Function Following Cardiac Surgery
This study is testing if inhaled nitric oxide can help improve lung function and heart performance in patients recovering from heart surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 54 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fundación de Investigación Biomédica - Hospital Universitario de La Princesa Academic / other |
| Locations | 1 site (Madrid) |
| Trial ID | NCT06097026 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effects of inhaled nitric oxide on pulmonary vasculature and right ventricular function in patients recovering from cardiac surgery. It aims to assess the combination of inhaled nitric oxide with an alveolar recruitment strategy to enhance gas exchange and improve heart performance. The study will involve a randomized controlled design, focusing on physiological variables to understand the mechanisms at play. A total of 54 patients will be recruited for this prospective study, which will take place in two hospitals during the first few hours post-surgery.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old who are mechanically ventilated and have postoperative lung collapse.
Not a fit: Patients with severe hypovolemia or unstable hemodynamics may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve recovery outcomes for patients undergoing cardiac surgery by enhancing lung function and heart performance.
How similar studies have performed: Other studies have shown promising results with inhaled nitric oxide in similar contexts, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
* Age \> 18 years * Under controlled mechanical ventilation in passive conditions * Presence of postoperative lung collapse (confirmed by pulmonary echocardiography and Air test) * Preoperative left ventricular ejection fraction (LVEF) ≥ 30%. * Absence of hypovolemia: absence of "kissing" ventricles and/or collapsibility index of the superior vena cava \< 20%. * Stable spontaneous heart rhythm * Postoperative hemodynamic stability: * Mean arterial pressure (MAP) ≥ 60 mmHg * Central venous pressure (CVP) ≥ 10 mmHg * Heart rate (HR) ≤ 100 bpm without tachyarrhythmias * Lactic acid ≤ 3 mmol/L * Single vasopressor treatment * Norepinephrine dose ≤ 0.2 μg/kg/min, without an increase ≥ 15% in the last 30 -minutes. Obtained informed consent
Where this trial is running
Madrid
- Fernando Suárez Sipmann — Madrid, Spain (Recruiting)
Study contacts
- Study coordinator: Fernando Suarez Sipmann, MD PhD
- Email: fsuarezsipmann@gmail.com
- Phone: +34 915202200
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.