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

NCT02345616 | Unknown Phase 2

• 2 other identifiers: CHU-02212014-003338-15
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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).

Conditions

Pulmonary Hypertension

Keywords

Cardiac surgery; Pulmonary hypertension; Nitric oxide; Induction anesthesia

Outcome Measures

Primary Outcomes (10)

• Pulmonary arterial systolic, diastolic and mean pressure

  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)

  at day 1

• Pulmonary arterial mean/arterial mean ratio

  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)

  at day 1

• SpO2 (Pulsed oxygen saturation)

  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)

  at day 1

• FeO2 (Fraction expired oxygen) (data not available just during intubation phase)

  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)

  at day 1

• Cardiac index

  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)

  at day 1

• Systemic vascular resistances

  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)

  at day 1

• SVO2 (Central Venous Saturation)

  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)

  at day 1

• Sat O2 (Blood oxygen saturation)

  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)

  at day 1

• PaO2 (Partial pressure of arterial oxygen)

  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)

  at day 1

• MetHb (methemoglobin)

  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)

  at day 1

Secondary Outcomes (1)

• Systolic, diastolic and mean arterial pressure

  at day 1

Study Arms (1)

Nitric oxyde

EXPERIMENTAL

Drug: Nitric oxide

Interventions

Nitric oxide DRUG

Nitric oxyde

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead
• ARAMU Association: collaborator

Study Sites (1)

CHU de Clermont-Ferrand

Clermont-Ferrand, 63003, France

RECRUITING

MeSH Terms

Conditions

Hypertension, Pulmonary

Interventions

Nitric Oxide

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Reactive Nitrogen Species; Free Radicals; Inorganic Chemicals; Nitrogen Oxides; Nitrogen Compounds; Oxides; Oxygen Compounds; Organic Chemicals

Study Officials

• Vedat ELJEZI

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick LACARIN

CONTACT

04 73 75 11 95; placarin@chu-clermontferrand.fr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2015
• First Posted: January 26, 2015
• Study Start: February 1, 2015
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: February 4, 2019

Record last verified: 2019-02

Locations

FR (1)