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

NCT06097026 | Recruiting DMC

• 1 other identifier: RONNIN- CCV
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Collapsed Lung; Hemodynamic Stability

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Electrical impedance tomography (EIT) derived variables

  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).

Study Arms (3)

Standard treatment (CONT)

NO INTERVENTION

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

iNO 20-40 ppm

EXPERIMENTAL

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.

Drug: Nitric Oxide

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

EXPERIMENTAL

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.

Procedure: Alveolar recruitment maneuver; Drug: Nitric Oxide

Interventions

Alveolar recruitment maneuver PROCEDURE

Progressive pressure increase on the ventilator to recruit collapsed alveoli and improve pulmonary ventilation.

Also known as: Alveolar recruitment

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

Nitric Oxide DRUG

Administer nitric oxide upon arrival from cardiac surgery and assess cardiac and pulmonary function afterwards.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

* 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Fernando Suarez Sipmann: lead
• Air Liquide SA: collaborator

Study Sites (1)

Fernando Suárez Sipmann

Madrid, 28006, Spain

RECRUITING

MeSH Terms

Conditions

Pulmonary Atelectasis

Interventions

Nitric Oxide

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Reactive Nitrogen Species; Free Radicals; Inorganic Chemicals; Nitrogen Oxides; Nitrogen Compounds; Oxides; Oxygen Compounds; Organic Chemicals

Central Study Contacts

Fernando Suarez Sipmann, MD PhD

CONTACT

+34 915202200; fsuarezsipmann@gmail.com

Isabel Magaña Bru, MD

CONTACT

+34 915202200; isabelmgbru@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD PhD Intesive Care Medicine, Principal Investigator

Study Record Dates

• First Submitted: September 26, 2023
• First Posted: October 24, 2023
• Study Start: November 22, 2023
• Primary Completion: August 1, 2024
• Study Completion: December 1, 2024
• Last Updated: February 28, 2024

Record last verified: 2024-02

Locations

ES (1)