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Respiratory Drive Response in COPD Patients During Exercise With Non Invasive Ventilation (NIV). (HFNIV)

J

Javier Sayas Catalan

Status

Completed

Conditions

Pulmonary Disease, Chronic Obstructive

Treatments

Other: Exercise with spontaneous ventilation.
Device: Exercise with HFNC
Device: Exercise with NIV

Study type

Observational

Funder types

Other

Identifiers

NCT04597606
NIV and HFNC EXERCISE COPD

Details and patient eligibility

About

A constant load exercise during 10 minutes will be performed in a group of Chronic Obstructive Pulmonary Disease patients, in a basal condition (spontaneous breathing); under noninvasive mask ventilation and with high flow nasal cannula. With the aim of reducing dyspnea, increasing exercise tolerance, and unload respiratory muscles, three exercises will be compared in terms of use of respiratory muscles and neural drive measured with paraesternal electromyography.

Full description

Exercise in chronic obstructive pulmonary disease is limited by dynamic hyperinflation and respiratory muscle overloadleading to severe dyspnea. During exercise, the increase in neural respiratory drive is notable to match ventilatory demand, correlated with breathlessness. Non-Invasive Ventilation may improve neural respiratory drive uncoupling and exercise tolerance. The aim of this study will be prove if Non-Invasive Ventilation and High flow nasal cannula during exercise reduces neural respiratory drive and improves dyspnea, measured with paraesternal electromyography

Enrollment

12 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients with severe COPD or cystic fibrosis (with an obstructive pattern and air trapping) on the waiting list for a lung transplant, assessed by the Lung Transplant Unit of the 12 de Octubre University Hospital.
  • Diagnostic criteria for COPD according to the GOLD and residual volume greater than 120% of theoretical
  • Evidence of developing dynamic air trapping by analyzing flow / volume curves during physical exercise.
  • Patients already adapted to home noninvasive mechanical ventilation (NIV) waiting for transplantation.

Exclusion criteria

  • Presence of comorbidities that limit the patient's physical effort capacity (uncontrolled ischemic heart disease, severe pulmonary hypertension, neuromuscular disease).
  • Refusal of treatment with NIV, or inclusion in the study.
  • Inability to perform the proposed exercise in basal conditions and with ventilation.

Trial design

12 participants in 1 patient group

Cohort
Description:
All patients will be performed a basal test that consist on continuous cyclergometer exercise, under constant load, with spontaneous breathing, after that the same exercise protocol performed will be carried out under non-invasive ventilation (NIV test). Parameters will be titrated previosuly. Finally the patient will perform the same exercise at a constant load under high flow oxygen therapy ( HFNC test).
Treatment:
Other: Exercise with spontaneous ventilation.
Device: Exercise with HFNC
Device: Exercise with NIV

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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