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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)

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ClinicalTrials.gov Identifier: NCT02345616
Recruitment Status : Unknown
Verified July 2016 by University Hospital, Clermont-Ferrand.
Recruitment status was:  Recruiting
First Posted : January 26, 2015
Last Update Posted : July 26, 2016
Sponsor:
Collaborator:
ARAMU Association
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

Brief Summary:

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).


Condition or disease Intervention/treatment Phase
Pulmonary Hypertension Drug: Nitric oxide Phase 2

Detailed Description:

Before the anesthetic induction every included patient will follow these protocol:

  • Standard monitoring (ECG Electrocardiogram, SpO2 Pulsed oxygen saturation)
  • Insertion of radial arterial line and periferic IV line under local anesthesia,
  • Insertion of a internal jugular central line and Swan Ganz catheter under local anesthesia
  • Preoxygenation in 100% oxygen for 10 min
  • Further preoxygenation with a mixture of 100% oxygen associated with the iNO in a dose of 1,2 L / mn.
  • Anesthesia induction and initiation of mechanical ventilation.
  • Progressive decrease of iNO dose and stop of iNO administration.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : February 2015
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Nitric oxyde Drug: Nitric oxide



Primary Outcome Measures :
  1. Pulmonary arterial systolic, diastolic and mean pressure [ Time Frame: at day 1 ]
    These measures will be taken each minute between t0 (conditioning of the patient's arrival in the operating room) and the time when FiO2 (Fraction of inspired oxygen) will be 60% (when the endotracheal tube is in place, between 30 and 40 minutes after t0)

  2. Pulmonary arterial mean/arterial mean ratio [ Time Frame: at day 1 ]
    These measures will be taken each minute between t0 (conditioning of the patient's arrival in the operating room) and the time when FiO2 (Fraction of inspired oxygen) will be 60% (when the endotracheal tube is in place, between 30 and 40 minutes after t0)

  3. SpO2 (Pulsed oxygen saturation) [ Time Frame: at day 1 ]
    These measures will be taken each minute between t0 (conditioning of the patient's arrival in the operating room) and the time when FiO2 (Fraction of inspired oxygen) will be 60% (when the endotracheal tube is in place, between 30 and 40 minutes after t0)

  4. FeO2 (Fraction expired oxygen) (data not available just during intubation phase) [ Time Frame: at day 1 ]
    These measures will be taken each minute between t0 (conditioning of the patient's arrival in the operating room) and the time when FiO2 (Fraction of inspired oxygen) will be 60% (when the endotracheal tube is in place, between 30 and 40 minutes after t0)

  5. Cardiac index [ Time Frame: at day 1 ]
    These measures will be taken each minute between t0 (conditioning of the patient's arrival in the operating room) and the time when FiO2 (Fraction of inspired oxygen) will be 60% (when the endotracheal tube is in place, between 30 and 40 minutes after t0)

  6. Systemic vascular resistances [ Time Frame: at day 1 ]
    These measures will be taken each minute between t0 (conditioning of the patient's arrival in the operating room) and the time when FiO2 (Fraction of inspired oxygen) will be 60% (when the endotracheal tube is in place, between 30 and 40 minutes after t0)

  7. SVO2 (Central Venous Saturation) [ Time Frame: at day 1 ]
    These measures will be taken each minute between t0 (conditioning of the patient's arrival in the operating room) and the time when FiO2 (Fraction of inspired oxygen) will be 60% (when the endotracheal tube is in place, between 30 and 40 minutes after t0)

  8. Sat O2 (Blood oxygen saturation) [ Time Frame: at day 1 ]
    These measures will be taken each minute between t0 (conditioning of the patient's arrival in the operating room) and the time when FiO2 (Fraction of inspired oxygen) will be 60% (when the endotracheal tube is in place, between 30 and 40 minutes after t0)

  9. PaO2 (Partial pressure of arterial oxygen) [ Time Frame: at day 1 ]
    These measures will be taken each minute between t0 (conditioning of the patient's arrival in the operating room) and the time when FiO2 (Fraction of inspired oxygen) will be 60% (when the endotracheal tube is in place, between 30 and 40 minutes after t0)

  10. MetHb (methemoglobin) [ Time Frame: at day 1 ]
    These measures will be taken each minute between t0 (conditioning of the patient's arrival in the operating room) and the time when FiO2 (Fraction of inspired oxygen) will be 60% (when the endotracheal tube is in place, between 30 and 40 minutes after t0)


Secondary Outcome Measures :
  1. Systolic, diastolic and mean arterial pressure [ Time Frame: at day 1 ]
    These measures will be taken each minute between t0 (conditioning of the patient's arrival in the operating room) and the time when FiO2 will be 60% (when the endotracheal tube is in place, between 30 and 40 minutes after t0)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Exclusion Criteria:

  • Heart transplant
  • HTP of type 1, 4, 5 according to the classification of Dana Point(2008)
  • Deficit in methemoglobin reductase
  • Protocole refuse from patient

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02345616


Contacts
Contact: Patrick LACARIN 04 73 75 11 95 placarin@chu-clermontferrand.fr

Locations
France
CHU de Clermont-Ferrand Recruiting
Clermont-Ferrand, France, 63003
Contact: Patrick LACARIN    04 73 75 11 95    placarin@chu-clermontferrand.fr   
Sub-Investigator: Henri BOBY         
Principal Investigator: Vedat ELJEZI         
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
ARAMU Association
Investigators
Principal Investigator: Vedat ELJEZI University Hospital, Clermont-Ferrand

Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT02345616     History of Changes
Other Study ID Numbers: CHU-0221
2014-003338-15 ( EudraCT Number )
First Posted: January 26, 2015    Key Record Dates
Last Update Posted: July 26, 2016
Last Verified: July 2016

Keywords provided by University Hospital, Clermont-Ferrand:
Cardiac surgery
Pulmonary hypertension
Nitric oxide
Induction anesthesia

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Anesthetics
Nitric Oxide
Central Nervous System Depressants
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Gasotransmitters
Protective Agents