Clinical Trials Logo

Clinical Trial Summary

An abnormally high V̇E/V̇CO2 response to exercise is a key pathophysiological feature of patients with chronic cardiopulmonary disease that is associated with adverse health outcomes. It follows that any intervention capable of decreasing the V̇E/V̇CO2 response to exercise has the potential to improve clinical and/or patient-reported outcomes. The investigators of this trial will compare the effects of orally administered sodium chloride (4 g, placebo) and sodium bicarbonate (0.3 g/kg of body mass) on ventilation, breathing pattern, dynamic operating lung volume, gas exhange, cardiovascular, metabolic and symptom parameters during symptom-limited, high-intensity, constant-work-rate cycle exercise testing in healthy adults aged 20-40 years.


Clinical Trial Description

The ventilatory response (V̇E) to exercise-induced increases in the rate of CO2 production (V̇CO2) depends on the regulated level of arterial PCO2 (PaCO2) and the dead space to tidal volume ratio (VD/VT).

An abnormally high V̇E/V̇CO2 response to exercise, reflecting a high VD/VT and/or low PaCO2 equilibrium point, is a key pathophysiological feature of patients with chronic cardiopulmonary disease, including heart failure, pulmonary arterial hypertension, interstitial lung disease and chronic obstructive pulmonary disease. In these patient groups, exercise ventilatory inefficiency is associated with: disease severity and progression; exercise intolerance; exertional breathlessness; and increased risk of hospitalization, major cardiac events and mortality. It follows that any intervention capable of decreasing the V̇E/V̇CO2 response to exercise has the potential to improve clinical and/or patient-reported outcomes. Unfortunately, our ability to enhance exercise ventilatory efficiency is limited by the fact that, with the possible exception of lung volume reduction surgery in chronic obstructive pulmonary disease and pulmonary vasodilator therapy in pulmonary arterial hypertension and heart failure, ventilation-perfusion abnormalities reflecting a high VD/VT are often irreversible.

A largely unexplored approach to decreasing the V̇E/V̇CO2 response to exercise is increasing the PaCO2 equilibrium point by inducing a metabolic alkalosis via administration of an alkalizing agent such as sodium bicarbonate (NaHCO3). Thus, the primary objective of this randomized, double blind, placebo controlled, crossover study was to test the hypothesis that increasing the PaCO2 equilibrium point via induced acute metabolic alkalosis by single-dose oral administration of NaHCO3 would decrease in the V̇E/V̇CO2 ratio at its lowest point ("nadir") during high-intensity constant-load cycle exercise testing in healthy adults. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03057535
Study type Interventional
Source McGill University
Contact
Status Completed
Phase Early Phase 1
Start date May 2015
Completion date September 2016

See also
  Status Clinical Trial Phase
Completed NCT03279458 - Non-invasive Tidal Volume Monitoring Using the Linshom Respiratory Monitoring Device N/A
Not yet recruiting NCT05532748 - Distribution of Pulmonary Ventilation With the Modified Pachon Incentive vs. Branded Respiratory Incentive N/A
Completed NCT02864017 - Immuno Nutrition by L-citrulline for Critically Ill Patients N/A
Withdrawn NCT03822689 - Comparison of Ventilation Tubes Among Anesthetized Pediatrics N/A
Recruiting NCT03577860 - Ventilation and Pulmonary Aeration, Electrical Impedance Tomography, Interscalene Brachial Plexus Block N/A
Recruiting NCT04237727 - CAvent-Ventilation During Advanced Cardiopulmonary Resuscitation in Out-of-hospital Cardiac Arrest- a Descriptive Study
Completed NCT03873233 - Flow Controlled Ventilation (FCV) With the Evone Ventilator and Tritube Versus Volume Controlled Ventilation (VCV) Phase 3
Completed NCT04667936 - Evaluation of Sedation in COVID-19 ARDS
Recruiting NCT05105932 - The Study of Regional Lung Ventilation-perfusion by EIT
Terminated NCT04274686 - Tegarderm® Placement for Bag Mask Ventilation in the Bearded Patient N/A
Completed NCT03839537 - Exposure of Taxi Drivers to Ultrafine Particles and Black Carbon Within Their Vehicles N/A
Completed NCT02828943 - Ventilatory Muscle Training in Stroke Phase 3
Completed NCT02825433 - Observing Changes in Ventilation Pattern During Procedural Sedation N/A