Role of Inhaled Nitric Oxide in Vascular Mechanics and Right Ventricular Function

Hemodynamic Stability Clinical Trial

Official title:

Role of Inhaled Nitric Oxide in Vascular Mechanics and Right Ventricular Function Following Cardiac Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06097026
• Other study ID #: RONNIN- CCV
• Status: Recruiting
• Phase: N/A
• Start date: November 22, 2023
• Est. completion date: December 2024

Study information

• Verified date: February 2024
• Source: Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
• Contact: Fernando Suarez Sipmann, MD PhD
• Phone: +34 915202200
• Email: fsuarezsipmann[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This study will evaluate modifiable pathophysiological treatments for postoperative pulmonary hypertension and right ventricular dysfunction. One pharmacological, inhaled nitric oxide, and one non-pharmacological, the OLA strategy combining lung recruitment and stabilization with individually optimized positive end-expiratory pressure (PEEP) and the possible synergistic effects of both interventions on right ventricular performance. Apart from acting specifically on the pathophysiological mechanisms described, the combination of an OLA strategy and iNO may be particularly beneficial, as modification of pulmonary status by OLA may, in theory, enhance the effects of iNO by significantly increasing gas exchange area and thus alveolar ventilation. A number of closely related physiological variables will also be studied to better characterize the effects of both strategies and their combination. This may help to better establish the indication for iNO in cardiac surgery patients and improve our understanding of mechanisms that are also present in ARDS patients, albeit on a different scale. This is a prospective randomized controlled physiological prospective study to be performed in two hospitals. The intervention period is limited to the first 2 -3 hours postoperatively. A total of 54 patients will be recruited.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 54
• Est. completion date: December 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

• 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

Related Conditions & MeSH terms

• Collapsed Lung
• Hemodynamic Stability
• Pneumothorax
• Pulmonary Atelectasis

Intervention

Procedure:
• Alveolar recruitment maneuver
Progressive pressure increase on the ventilator to recruit collapsed alveoli and improve pulmonary ventilation.

Drug:
• Nitric Oxide
Administer nitric oxide upon arrival from cardiac surgery and assess cardiac and pulmonary function afterwards.

Locations

Country	Name	City	State
Spain	Fernando Suárez Sipmann	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Fernando Suarez Sipmann	Air Liquide SA

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Right ventricular cardiac function specifically those directly related to the estimation ofright ventricular-vascular coupling	The parameters will be evaluated by TEE. Right ventricular function parameters will be assessed by the ratio of right ventricular end-diastolic to left ventricular end-diastolic diameters, right ventricular shortening fraction, tricuspid annular plane systolic excursion (TAPSE), myocardial performance index (MPI). estimation of systolic pulmonary artery pressure (PAPs), estimation of pulmonary vascular resistance by Doppler, Right ventricular outflow tract notch pattern, right ventricular outflow tract acceleration time (RVOT-AT).	A first TTE baseline measurement (T1) will be taken after arrival in the ICU after cardiac surgery, then another measurement will be taken 30 minutes after the first intervention (at iNO) (T2), and a new measurement will be taken 30 minutes later (T3).
Secondary	Electrical impedance tomography (EIT) derived variables	With electrical impedance tomography (EIT), investigators will analyze the regional distribution of lung ventilation and percussion, the relative distribution of ventilation and percussion in predefined regions of interest, changes in lung aeration (end-expiratory lung volume difference) and pulmonary artery pulsatility.	A first baseline measurement (T1) will be taken after arrival at the ICU after cardiac surgery, then another measurement will be taken 30 minutes after the first intervention (in iNO) (T2), and a new measurement will be taken 30 minutes later (T3).