Role of Inhaled Nitric Oxide in Vascular Mechanics and Right Ventricular Function
NCT ID: NCT06097026
Last Updated: 2024-02-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
54 participants
INTERVENTIONAL
2023-11-22
2024-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Standard treatment (CONT)
The patient will be managed according to the routine clinical protocol, homogenizing the interventions in both participating centers.
No interventions assigned to this group
iNO 20-40 ppm
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.
Nitric Oxide
Administer nitric oxide upon arrival from cardiac surgery and assess cardiac and pulmonary function afterwards.
iNO 20 - 40 ppm + Lung recruitment (iNO-RM)
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.
Alveolar recruitment maneuver
Progressive pressure increase on the ventilator to recruit collapsed alveoli and improve pulmonary ventilation.
Nitric Oxide
Administer nitric oxide upon arrival from cardiac surgery and assess cardiac and pulmonary function afterwards.
Interventions
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Alveolar recruitment maneuver
Progressive pressure increase on the ventilator to recruit collapsed alveoli and improve pulmonary ventilation.
Nitric Oxide
Administer nitric oxide upon arrival from cardiac surgery and assess cardiac and pulmonary function afterwards.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Air Liquide SA
INDUSTRY
Fernando Suarez Sipmann
OTHER
Responsible Party
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Fernando Suarez Sipmann
MD PhD Intesive Care Medicine, Principal Investigator
Locations
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Fernando Suárez Sipmann
Madrid, , Spain
Countries
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Central Contacts
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Facility Contacts
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Provided Documents
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Document Type: Study Protocol
Other Identifiers
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RONNIN- CCV
Identifier Type: -
Identifier Source: org_study_id
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