Status:
RECRUITING
Role of Inhaled Nitric Oxide in Vascular Mechanics and Right Ventricular Function
Lead Sponsor:
Fernando Suarez Sipmann
Collaborating Sponsors:
Air Liquide SA
Conditions:
Collapsed Lung
Hemodynamic Stability
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The aim of this study is to evaluate the role of nitric oxide on pulmonary vasculature and right ventricular function in postoperative cardiac surgery patients.
Detailed Description
This study will evaluate modifiable pathophysiological treatments for postoperative pulmonary hypertension and right ventricular dysfunction. One pharmacological, inhaled nitric oxide, and one non-ph...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
November 22 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT06097026
Start Date
November 22 2023
End Date
December 1 2024
Last Update
February 28 2024
Active Locations (1)
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1
Fernando Suárez Sipmann
Madrid, Spain, 28006