Collapsed Lung, Hemodynamic Stability
Conditions
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.
Interventions
PROCEDUREAlveolar recruitment maneuver
Progressive pressure increase on the ventilator to recruit collapsed alveoli and improve pulmonary ventilation.
DRUGNitric Oxide
Administer nitric oxide upon arrival from cardiac surgery and assess cardiac and pulmonary function afterwards.
Sponsors
Air Liquide SA
Fernando Suarez Sipmann
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Right ventricular cardiac function specifically those directly related to the estimation ofright ventricular-vascular coupling | 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). | 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
| Measure | Time frame | Description |
|---|---|---|
| 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). | 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. |
Countries
Spain
Contacts
Primary ContactFernando Suarez Sipmann, MD PhD
Backup ContactIsabel Magaña Bru, MD
Outcome results
None listed