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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)

Primary Purpose

Pulmonary Hypertension

Status
Unknown status
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Nitric oxide
Sponsored by
University Hospital, Clermont-Ferrand
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Hypertension focused on measuring Cardiac surgery, Pulmonary hypertension, Nitric oxide, Induction anesthesia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU de Clermont-FerrandRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Nitric oxyde

Arm Description

Outcomes

Primary Outcome Measures

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)
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)
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)
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)
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)
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)
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)
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)
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)
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)

Secondary Outcome Measures

Systolic, diastolic and mean arterial 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 will be 60% (when the endotracheal tube is in place, between 30 and 40 minutes after t0)

Full Information

First Posted
January 20, 2015
Last Updated
February 1, 2019
Sponsor
University Hospital, Clermont-Ferrand
Collaborators
ARAMU Association
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1. Study Identification

Unique Protocol Identification Number
NCT02345616
Brief 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
Acronym
NOCaPH
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 Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 2015 (undefined)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand
Collaborators
ARAMU Association

4. Oversight

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Hypertension
Keywords
Cardiac surgery, Pulmonary hypertension, Nitric oxide, Induction anesthesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Nitric oxyde
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Nitric oxide
Primary Outcome Measure Information:
Title
Pulmonary arterial systolic, diastolic and mean pressure
Description
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)
Time Frame
at day 1
Title
Pulmonary arterial mean/arterial mean ratio
Description
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)
Time Frame
at day 1
Title
SpO2 (Pulsed oxygen saturation)
Description
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)
Time Frame
at day 1
Title
FeO2 (Fraction expired oxygen) (data not available just during intubation phase)
Description
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)
Time Frame
at day 1
Title
Cardiac index
Description
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)
Time Frame
at day 1
Title
Systemic vascular resistances
Description
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)
Time Frame
at day 1
Title
SVO2 (Central Venous Saturation)
Description
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)
Time Frame
at day 1
Title
Sat O2 (Blood oxygen saturation)
Description
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)
Time Frame
at day 1
Title
PaO2 (Partial pressure of arterial oxygen)
Description
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)
Time Frame
at day 1
Title
MetHb (methemoglobin)
Description
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)
Time Frame
at day 1
Secondary Outcome Measure Information:
Title
Systolic, diastolic and mean arterial pressure
Description
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)
Time Frame
at day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patrick LACARIN
Phone
04 73 75 11 95
Email
placarin@chu-clermontferrand.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vedat ELJEZI
Organizational Affiliation
University Hospital, Clermont-Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrick LACARIN
Phone
04 73 75 11 95
Email
placarin@chu-clermontferrand.fr
First Name & Middle Initial & Last Name & Degree
Henri BOBY
First Name & Middle Initial & Last Name & Degree
Vedat ELJEZI

12. IPD Sharing Statement

Learn more about this trial

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

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