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

NCT04597606 | Completed

• 1 other identifier: NIV and HFNC EXERCISE COPD
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

Noninvasive Ventilation; Exercise

Outcome Measures

Primary Outcomes (1)

• Changes in Neural ventilator (NVU) (%)

  the peak value (on the baseline) of the maximum muscle activity ( Root mean square EMG value in mV), both diaphragmatic (EMGDimax) and parasternal (EMGparamax) in the máximum intentional ventilation and maximum inspiratory peak (MIP) will be taken. This value will be consider 100% and based on this mean EMG will be calculate for a normalized EMGdi (RMS) and paraesternal in each ventilatory situation (spontaneous ventilation or under NIV). At each effort point (in each minute of the exercise protocol), the relationship between the normalized EMG value (parasternal and Diaphragmatic) and the tidal volume (obtained by integral of flow signal by means of a pneumotachograph connected to the VM -in NIV- or oronasal hermetic mask -in Vesp). To facilitate the interpretation of the expired TV, the mask without leakage will be used with the intentional leak connected in the circuit, before the pneumotachograph.

  24 hours, 48 hours, 72 hours

Secondary Outcomes (17)

• Borg Scale Dyspnea evolution (points)

  Basal value at day 1 and every 60 seconds during the exercise

• Borg Scale Dyspnea evolution (points)

  24 hours later than day 1 (day 2) during the exercise every 60 seconds

• Borg Scale Dyspnea evolution (points)

  48 hours later than day 1 (day 3) during the exercise every 60 seconds

• Borg Scale Dyspnea evolution (points)

  72 hours later than day 1 (day 4) during the exercise every 60 seconds

• Transcutaneous pCO2 Final - inicial (mmHg)

  Basal value at day 1 during the exercise

Study Arms (1)

Cohort

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).

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

Interventions

Exercise with spontaneous ventilation. OTHER

Patients will perform 10 minutes, constant load, exercise in a cycloergometer. To set the load, a baseline incremental effort test will be performed previously (VISIT 1). Then, in a separate day (VISIT 2), the subject will perform 10 minutes cycling at the 75% load of that determined as maximum in VISIT 1, at a constant rate of 30 to 35 pedal revolutions per minute, in spontaneous breathing, with low flow oxygen through conventional nasal cannula adjusted to achieve SpO2 between 92to 94%

Cohort

Exercise with NIV DEVICE

VISIT 2 Non invasive mask ventilation: parameters will be titrated during a free cycling period at the end of the spontaneous breathing exercise. Then, in a separate day (VISIT 3), with the same constant load, cycling cadence and under NIV, the patient will perform 10 min of cycling.

Cohort

Exercise with HFNC DEVICE

With constant flows of 50 lpm and with FiO2 adjusted according to SPO2, to obtain a constant saturation between 92 and 94%. The same pedaling load and frequency will be maintained, with similar variables collected.

Cohort

Eligibility Criteria

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

Study Population

Patients will be recluted from the pneumology outpatient clinic of the Hospital 12 de Octubre

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Javier Sayas Catalan: lead

Study Sites (1)

Javier Sayas Catalan

Madrid, 28041, Spain

Location

Related Publications (1)

• Sayas J, Lalmolda C, Corral M, Florez P, Hernandez-Voth A, Janssens JP, Rabec C, Langevin B, Lofaso F, Carlucci A, Llontop C, Winck JC, Bermejo JG, Lujan M. Measurement of thoraco-abdominal synchrony using respiratory inductance plethysmography: technical aspects and a proposal to overcome its limitations. Expert Rev Respir Med. 2024 Mar-Apr;18(3-4):227-236. doi: 10.1080/17476348.2024.2363058. Epub 2024 Jun 7.

  PMID: 38829281 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Motor Activity

Interventions

Exercise; Exercise Therapy; Noninvasive Ventilation

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Respiration, Artificial; Airway Management; Respiratory Therapy

Study Officials

• Javier Sayas

  Hospital 12 de OCtubre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator: Javier Sayas Catalan, Medical Doctor

Study Record Dates

• First Submitted: September 18, 2020
• First Posted: October 22, 2020
• Study Start: September 2, 2019
• Primary Completion: November 15, 2022
• Study Completion: November 15, 2022
• Last Updated: November 23, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)