Informations générales (source: ClinicalTrials.gov)
Role of the Nitric Oxide (NO) in Pre-oxygenation Before Anesthetic Induction in Patients With a Pulmonary Hypertension in Cardiac Surgery. Pilot Study of Feasibility (NOCaPH)
Interventional
Phase 2
University Hospital, Clermont-Ferrand (Voir sur ClinicalTrials)
février 2015
décembre 2019
29 juin 2024
The pulmonary hypertension (HTP) due to a left heart disease or a hypoxemiant lung
disease is frequent in cardiac surgery. The HTP represents an independent risk factor of
morbidity and mortality in cardiac surgery, entering to the criteria of Euroscore
evaluation (European System for Cardiac Operative Risk Evaluation).
An acute perioperative hemodynamic decompensation of these patients is frequent.
Perioperative hemodynamic modifications, hypoxemia, hypercapnia, sympathetic stimulation,
increase pulmonary vascular resistances (RVP) and might provoke right ventricular
failure.
The anesthetic induction and the beginning of mechanical ventilation are the most
sensible times due to the risk of hemodynamic decompensation. The suppression of the
sympathetic tonus which is consequence of the anesthetic induction, decrease the systemic
vascular resistances and lead to decrease of blood pressure. In return, the anesthetic
induction is associated with an increase of pulmonary vascular resistances, resulting in
increase of the postcharge and the work of the right ventricle (VD). These systemic and
pulmonary hemodynamic modifications can lead to equalization, or even an inversion of the
systemic and pulmonary pressures. As consequence, a hemodynamic collapse or even a heart
arrest can arise.
The patients suffering from HTP are hypoxemic. They have very limited oxygen reserves due
to decrease of the functional residual capacity (CRF). The apnea period, which follows
the anesthetic induction, is often associated with a fast desaturation, even if a good
pre-oxygenation was performed before. This desaturation causes an increase of the
pulmonary vascular resistances with the hemodynamic consequences previously mentioned. A
risk of hypoxic heart arrest is also present.
Nitric Oxide (NO) is an endogenous mediator produced from the vascular endothelium. The
NO is a powerful vasodilator and is used in intensive care in inhaled way as selective
pulmonary vasodilator (iNO). NO decreases the RVP, the shunt effect and improves the
oxygenation by optimization of ventilation-perfusion ratio. The short lifetime of iNO
(6sec approximately) allows a fast metabolism without inducing any undesirable effects
such as the systemic hypotension.
No studies, until now, have investigated the use of iNO in pre-oxygenation before
anesthetic induction in cardiac surgery.
We hope to demonstrate that iNO used in oxygenation before anesthetic induction will have
a beneficial effect on the respiratory and cardiovascular parameters.
Our objective is to estimate the feasibility and the tolerance of iNO before anesthetic
induction of the patients with a moderate or severe HTP programmed for cardiac surgery
with extracorporeal circulation. The effect will be estimated in terms of efficiency
(hemodynamic and respiratory optimization).
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CHU de Clermont-Ferrand - 63003 - Clermont-Ferrand - France | Patrick LACARIN | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- Age > 18 years old
- Open-heart cardiac surgery
- HTP Pulmonary hypertension (class 2 or 3) with PAPs (Systolic pulmonary artery
pressure) > 40 mmHg diagnosed by preoperative righ cardiac catheterization or by
transthoracic echocardiography.
- Patient have signed their consent according to the modalities described by the Code
of Public health system.
- Patients affiliated to a national insurance (social security) system.
- Age > 18 years old
- Open-heart cardiac surgery
- HTP Pulmonary hypertension (class 2 or 3) with PAPs (Systolic pulmonary artery
pressure) > 40 mmHg diagnosed by preoperative righ cardiac catheterization or by
transthoracic echocardiography.
- Patient have signed their consent according to the modalities described by the Code
of Public health system.
- Patients affiliated to a national insurance (social security) system.
- Heart transplant
- HTP of type 1, 4, 5 according to the classification of Dana Point(2008)
- Deficit in methemoglobin reductase
- Protocole refuse from patient