search
Back to results

Dead Space Evaluation in Pulmonary Hypertension

Primary Purpose

Pulmonary Hypertension

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
cardiopulmonary exercise test,hypoxia and hypercapnia test
Sponsored by
Centro Cardiologico Monzino
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pulmonary Hypertension

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • age ≥18 and ≤ 80 years
  • ability to understand the research protocol and willing to sign the study informed consent
  • diagnosis of pulmonary arterial hypertension belonging to Class I and IV
  • stable haemodynamic status and optimized medical treatment since at least 2 months
  • ability to perform maximal cardiopulmonary exercise test and pulmonary diffusing capacity for carbon monoxide evaluation

Exclusion Criteria:

  • relevant comorbidities
  • usual contraindications for cardiopulmonary exercise test
  • pulmonary hypertension associated to left heart and pulmonary disease, congenital heart diseases with evident cardiac shunts.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Pulmonary hypertension patients

    Arm Description

    All Pulmonary hypertension patients enrolled in the study underwent a cardiopulmonary exercise test and hypoxia and hypercapnia tests

    Outcomes

    Primary Outcome Measures

    dead space ventilation (measured in L/min)
    Dead space ventilation is calculated through the equation: VT* [1- (863*VCO2)/(VE*PaCO2)], where VT = tidal volume, VCO2= CO2 output, VE= pulmonary ventilation,PaCO2 is the arterial partial pressure of CO2 and 863 is a constant.

    Secondary Outcome Measures

    peripheral response to hypoxia (measured in L/min/O2)
    the hypoxic test is based on the transient hypoxia (the patient inhales a mixture of nitrogen for 2-8 breaths, for 10-15 times); pulmonary ventilation (VE) and arterial oxygen saturation (O2 Saturation) by peripheral pulse oximetry is measured. The chemoreceptor sensitivity value is calculated as the slope of the trend line built on the two maximum consecutive VE and minimum O2 Saturation of each test.
    peripheral response to hypercapnia (measured in L/min/mmHg)
    the peripheral response to hypercapnia is evaluated through the single-breath technique (the patient inhales a mixture of 13% CO2 in air for a single breath); pulmonary ventilation (VE) and end-expiratory CO2 fraction (FetCO2) are measured and then they will be used to calculate the peripheral chemoreceptor sensitivity.In fact, the sensitivity of the chemoreceptor is calculated using the following formula VEs-VEc / (FetCO2s-FetCO2c) * (PB-47), where s and c indicate the data collected after hypercapnic stimulus and those collected during control air breathing ,respectively; PB is the atmospheric pressure in mmHg
    central hypercapnic chemosensitivity (measured in L/min/mmHg)
    the evaluation of the central response to hypercapnia is made through the re-breathing technique (the patient breathes through a reservoir containing 7% CO2 and 93% O2 for 4 minutes); pulmonary ventilation (VE) and partial pressure of end-tidal carbon dioxide (PetCO2) are evaluated. The slope of the curve describing the relationship between VE and PetCO2 identifies the central chemoreceptor sensitivity

    Full Information

    First Posted
    June 10, 2016
    Last Updated
    September 2, 2016
    Sponsor
    Centro Cardiologico Monzino
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02892981
    Brief Title
    Dead Space Evaluation in Pulmonary Hypertension
    Official Title
    Dead Space Evaluation During Exercise in Patients With Pulmonary Hypertension
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2015 (undefined)
    Primary Completion Date
    January 2016 (Actual)
    Study Completion Date
    April 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Centro Cardiologico Monzino

    4. Oversight

    5. Study Description

    Brief Summary
    Aim of the study is to evaluate the role of chemoreceptor activity and ventilation perfusion mismatch on the genesis of exercise induced hyperventilation in Pulmonary hypertension patients. So the investigators tested the chemoreceptor response at rest, both with hypoxic and hypercapnic stimuli, and the ventilatory response during exercise analyzing its two components, alveolar and dead space ventilation.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pulmonary Hypertension

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    18 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Pulmonary hypertension patients
    Arm Type
    Other
    Arm Description
    All Pulmonary hypertension patients enrolled in the study underwent a cardiopulmonary exercise test and hypoxia and hypercapnia tests
    Intervention Type
    Other
    Intervention Name(s)
    cardiopulmonary exercise test,hypoxia and hypercapnia test
    Intervention Description
    class I and IV Pulmonary hypertension patients in stable haemodynamic status and optimized medical therapy underwent cardiopulmonary test and hypoxia and hypercapnia tests to evaluate the chemoreceptor sensitivity
    Primary Outcome Measure Information:
    Title
    dead space ventilation (measured in L/min)
    Description
    Dead space ventilation is calculated through the equation: VT* [1- (863*VCO2)/(VE*PaCO2)], where VT = tidal volume, VCO2= CO2 output, VE= pulmonary ventilation,PaCO2 is the arterial partial pressure of CO2 and 863 is a constant.
    Time Frame
    1 week
    Secondary Outcome Measure Information:
    Title
    peripheral response to hypoxia (measured in L/min/O2)
    Description
    the hypoxic test is based on the transient hypoxia (the patient inhales a mixture of nitrogen for 2-8 breaths, for 10-15 times); pulmonary ventilation (VE) and arterial oxygen saturation (O2 Saturation) by peripheral pulse oximetry is measured. The chemoreceptor sensitivity value is calculated as the slope of the trend line built on the two maximum consecutive VE and minimum O2 Saturation of each test.
    Time Frame
    1 week
    Title
    peripheral response to hypercapnia (measured in L/min/mmHg)
    Description
    the peripheral response to hypercapnia is evaluated through the single-breath technique (the patient inhales a mixture of 13% CO2 in air for a single breath); pulmonary ventilation (VE) and end-expiratory CO2 fraction (FetCO2) are measured and then they will be used to calculate the peripheral chemoreceptor sensitivity.In fact, the sensitivity of the chemoreceptor is calculated using the following formula VEs-VEc / (FetCO2s-FetCO2c) * (PB-47), where s and c indicate the data collected after hypercapnic stimulus and those collected during control air breathing ,respectively; PB is the atmospheric pressure in mmHg
    Time Frame
    1 week
    Title
    central hypercapnic chemosensitivity (measured in L/min/mmHg)
    Description
    the evaluation of the central response to hypercapnia is made through the re-breathing technique (the patient breathes through a reservoir containing 7% CO2 and 93% O2 for 4 minutes); pulmonary ventilation (VE) and partial pressure of end-tidal carbon dioxide (PetCO2) are evaluated. The slope of the curve describing the relationship between VE and PetCO2 identifies the central chemoreceptor sensitivity
    Time Frame
    1 week

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: age ≥18 and ≤ 80 years ability to understand the research protocol and willing to sign the study informed consent diagnosis of pulmonary arterial hypertension belonging to Class I and IV stable haemodynamic status and optimized medical treatment since at least 2 months ability to perform maximal cardiopulmonary exercise test and pulmonary diffusing capacity for carbon monoxide evaluation Exclusion Criteria: relevant comorbidities usual contraindications for cardiopulmonary exercise test pulmonary hypertension associated to left heart and pulmonary disease, congenital heart diseases with evident cardiac shunts.

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    29579597
    Citation
    Farina S, Bruno N, Agalbato C, Contini M, Cassandro R, Elia D, Harari S, Agostoni P. Physiological insights of exercise hyperventilation in arterial and chronic thromboembolic pulmonary hypertension. Int J Cardiol. 2018 May 15;259:178-182. doi: 10.1016/j.ijcard.2017.11.023.
    Results Reference
    derived

    Learn more about this trial

    Dead Space Evaluation in Pulmonary Hypertension

    We'll reach out to this number within 24 hrs