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

Fernando Suarez Sipmann

Status: Enrolling

Conditions: Collapsed Lung; Hemodynamic Stability

Treatments: Procedure: Alveolar recruitment maneuver; Drug: Nitric Oxide

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06097026

RONNIN- CCV

Details and patient eligibility

About

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.

Full 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.

Enrollment: 54 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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54 participants in 3 patient groups

Standard treatment (CONT)

No Intervention group

Description:

The patient will be managed according to the routine clinical protocol, homogenizing the interventions in both participating centers.

iNO 20-40 ppm

Experimental group

Description:

In this arm, inhaled nitric oxide therapy will be initiated at 20 ppm immediately after randomization and after initial data collection. The dose will be reassessed after the first 30 min and may be increased to a maximum of 40 ppm depending on the response observed in ventricular function.

Treatment:

Drug: Nitric Oxide

iNO 20 - 40 ppm + Lung recruitment (iNO-RM)

Experimental group

Description:

After 30 min after initiation of nitric oxide therapy following randomization, once patient stability has been confirmed, a brief recruitment maneuver will be performed and the subsequent PEEP level will be individualized according to the best lung compliance. Ventilation will then continue with the standard baseline ventilator settings, but with the PEEP level individually optimized.

Treatment:

Drug: Nitric Oxide

Procedure: Alveolar recruitment maneuver