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

Primary Purpose

Collapsed Lung, Hemodynamic Stability

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Alveolar recruitment maneuver
Nitric Oxide
Sponsored by
Fernando Suarez Sipmann
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Collapsed Lung

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    No Intervention

    Experimental

    Experimental

    Arm Label

    Standard treatment (CONT)

    iNO 20-40 ppm

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

    Arm Description

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

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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).

    Secondary Outcome Measures

    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.

    Full Information

    First Posted
    September 26, 2023
    Last Updated
    October 20, 2023
    Sponsor
    Fernando Suarez Sipmann
    Collaborators
    Air Liquide SA
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06097026
    Brief Title
    Role of Inhaled Nitric Oxide in Vascular Mechanics and Right Ventricular Function
    Official Title
    Role of Inhaled Nitric Oxide in Vascular Mechanics and Right Ventricular Function Following Cardiac Surgery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 25, 2023 (Anticipated)
    Primary Completion Date
    August 2024 (Anticipated)
    Study Completion Date
    December 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Fernando Suarez Sipmann
    Collaborators
    Air Liquide SA

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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-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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Collapsed Lung, Hemodynamic Stability

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    54 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Standard treatment (CONT)
    Arm Type
    No Intervention
    Arm Description
    The patient will be managed according to the routine clinical protocol, homogenizing the interventions in both participating centers.
    Arm Title
    iNO 20-40 ppm
    Arm Type
    Experimental
    Arm 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.
    Arm Title
    iNO 20 - 40 ppm + Lung recruitment (iNO-RM)
    Arm Type
    Experimental
    Arm 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.
    Intervention Type
    Procedure
    Intervention Name(s)
    Alveolar recruitment maneuver
    Other Intervention Name(s)
    Alveolar recruitment
    Intervention Description
    Progressive pressure increase on the ventilator to recruit collapsed alveoli and improve pulmonary ventilation.
    Intervention Type
    Drug
    Intervention Name(s)
    Nitric Oxide
    Intervention Description
    Administer nitric oxide upon arrival from cardiac surgery and assess cardiac and pulmonary function afterwards.
    Primary Outcome Measure Information:
    Title
    Right ventricular cardiac function specifically those directly related to the estimation ofright ventricular-vascular coupling
    Description
    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).
    Time Frame
    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 Outcome Measure Information:
    Title
    Electrical impedance tomography (EIT) derived variables
    Description
    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.
    Time Frame
    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).

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Fernando Suarez Sipmann, MD PhD
    Phone
    +34 915202200
    Email
    fsuarezsipmann@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Isabel Magaña Bru, MD
    Phone
    +34 915202200
    Email
    isabelmgbru@gmail.com

    12. IPD Sharing Statement

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

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