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Effect of Portable NIV on Operational Chest Wall Volumes in COPD

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ClinicalTrials.gov Identifier: NCT03848819
Recruitment Status : Not yet recruiting
First Posted : February 21, 2019
Last Update Posted : February 21, 2019
Sponsor:
Collaborator:
North Tyneside General Hospital
Information provided by (Responsible Party):
Northumbria University

Brief Summary:

The VitaBreath (Philips, Respironics) is a portable, handheld, battery powered, non-invasive ventilation device, that has been shown by our group to reduce activity-related shortness of breath in patients with COPD. It delivers 18 cmH2O inspiratory and 8 cmH2O expiratory pressures, but can only be used during recovery periods.

Our previous study (REC: 17/NE/0085) showed that use of the VitaBreath device during the recovery periods interspersing successive exercise bouts enhances exercise tolerance and reduces breathlessness compared to pursed lip breathing in patients with COPD. This was attributed to faster recovery from exercise-induced dynamic hyperinflation, assessed by volitional inspiratory capacity manoeuvres using a spirometer. However, inspiratory capacity manoeuvres are effort dependent, thus limiting the number of repetitions the patient can perform during exercise. In addition, investigation of the direct effect of the application of the VitaBreath device on dynamic hyperinflation was not possible due to the need to employ a spirometer for assessing inspiratory capacity. Optoelectronic plethysmography (OEP) allows continuous non-invasive assessment of end-inspiratory and end-expiratory volumes of the thoracoabdominal wall and its compartments, thereby facilitating assessment of dynamic hyperinflation on a breath-by-breath basis without the necessity to breathe via a spirometer. Unfortunately, OEP technology was not available at the time of our previous study.

The investigators will use OEP to provide accurate breath-by-breath volume measurements during exercise and recovery to evaluate whether the VitaBreath device reduces total and compartmental thoracoabdominal wall volumes compared to the pursed lip breathing technique.

Furthermore, the investigators will investigate the effect of use of the VitaBreath device on respiratory muscle activation and respiratory muscle oxygenation using OEP technology in conjunction with electromyography (EMG) and near inferred spectroscopy (NIRS), respectively to appreciate how the application of the VitaBreath device impacts on the operation and energy demands of the respiratory muscles as compared to control pursed lip breathing.

The investigators hypothesised that the use of the VitaBreath device during the recovery periods interspersing successive exercise bouts will reduce the magnitude of dynamic hyperinflation in a greater extent compared to the pursed lip breathing technique.


Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Device: VitaBreath device Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: This is a randomised crossover trial. Patients will perform two identical exercise tests and the intervention (VitaBreath) will be compared to control condition (pursed-lip breathing) in the same patients.The order of testing will be determined by simple randomisation (sealedenvelope.com).
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Effect of the VitaBreath Device on Chest Wall Dynamic Hyperinflation and Respiratory Muscle Activation During Recovery From Exercise in Patients With Chronic Obstructive Pulmonary Disease
Estimated Study Start Date : May 1, 2019
Estimated Primary Completion Date : December 20, 2019
Estimated Study Completion Date : December 20, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Control pursed lip breathing
Patients will undergo one intermittent exercise protocols on a cycle ergometer. The exercise protocol will consist of repeated 2-min exercise bouts, separated by 2-min recovery periods in between work bouts. During the 1st min of each recovery period patients will breathe adopting the pursed lip breathing technique. During the 2nd min of each recovery period patients will breathe normally. Patients will also score the intensity of their perceived dyspnoea using the Borg 1-10 scale. Cardiac output and stroke volume will be measured non-invasively using a cardio-impedance method (physio-flow) throughout the exercise and recovery periods. Respiratory muscle activation (EMG) and local respiratory muscle oxygen tissue oxygenation (NIRS) will be continuously recorded non-invasively using optodes placed on the skin throughout the exercise and recovery periods. In addition, arterial oxygen saturation will be recorded throughout the exercise and recovery periods using a pulse oximeter.
Device: VitaBreath device
The VitaBreath (Philips, Respironics) is a portable, handheld, battery powered, non-invasive ventilation device, that has been shown by our group to reduce activity-related shortness of breath in patients with COPD. It delivers 18 cmH2O inspiratory and 8 cmH2O expiratory pressures, but can only be used during recovery periods. In our study patients will perform consecutive bouts of exercise alternated by two minute of recovery in order to allow the use of the VitaBreath device during the first minute of each recovery period.

Experimental: pNIV
Patients will undergo one intermittent exercise protocols on a cycle ergometer. The exercise protocol will consist of repeated 2-min exercise bouts, separated by 2-min recovery periods in between work bouts. During the 1st min of each recovery period patients will breathe via the VitaBreath device. During the 2nd min of each recovery period patients will breathe normally. Patients will also score the intensity of their perceived dyspnoea using the Borg 1-10 scale. Cardiac output and stroke volume will be measured non-invasively using a cardio-impedance method (physio-flow) throughout the exercise and recovery periods. Respiratory muscle activation (EMG) and local respiratory muscle oxygen tissue oxygenation (NIRS) will be continuously recorded non-invasively using optodes placed on the skin throughout the exercise and recovery periods. In addition, arterial oxygen saturation will be recorded throughout the exercise and recovery periods using a pulse oximeter.
Device: VitaBreath device
The VitaBreath (Philips, Respironics) is a portable, handheld, battery powered, non-invasive ventilation device, that has been shown by our group to reduce activity-related shortness of breath in patients with COPD. It delivers 18 cmH2O inspiratory and 8 cmH2O expiratory pressures, but can only be used during recovery periods. In our study patients will perform consecutive bouts of exercise alternated by two minute of recovery in order to allow the use of the VitaBreath device during the first minute of each recovery period.




Primary Outcome Measures :
  1. The magnitude of change in thoracoabdominal wall dynamic hyperinflation. [ Time Frame: The intervention will be performed in one visit. During the visit patients will perform 2 trials lasting for 20 minutes each. The outcome 1 will be assessed at rest, at the 20th minute of cycling and 5 minutes post cycling at each trial. ]
    Change from baseline in litres of thoracoabdominal wall volume at end of exercise and recovery from exercise from resting breathing.


Secondary Outcome Measures :
  1. Compartmental thoracoabdominal wall volumes (rib cage and abdominal volumes) assessed by OEP. [ Time Frame: The intervention will be performed in one visit. During the visit patients will perform 2 trials lasting for 20 minutes each. The outcome 2 will be assessed at rest, at the 20th minute of cycling and 5 minutes post cycling at each trial. ]
    Change from baseline in litres of compartmental thoracoabdominal wall volume at end of exercise and recovery from exercise from resting breathing.

  2. Electromyographic activation (expressed as fractions of peak activation and in absolute terms in mV) assessed by surface electromyography [ Time Frame: The intervention will be performed in one visit. During the visit patients will perform 2 trials lasting for 20 minutes each. The outcome 3 will be assessed at rest, at the 20th minute of cycling and 5 minutes post cycling at each trial. ]
    Change from baseline in integrated EMG signal from respiratory muscles at end of exercise and recovery from exercise from resting breathing.

  3. Respiratory muscle oxygenation requirements recorded from the intercostal and abdominal muscles by near infrared spectroscopy including measurements of: total haemoglobin (TOI), oxygenated haemoglobin (HbO2) and deoxygenated haemoglobin (HHb). [ Time Frame: The intervention will be performed in one visit. During the visit patients will perform 2 trials lasting for 20 minutes each. The outcome 4 will be assessed at rest, at the 20th minute of cycling and 5 minutes post cycling at each trial. ]
    Change from baseline in fractional oxygen saturation of the respiratory muscles at end of exercise and recovery from exercise from resting breathing.

  4. Cardiac output responses assessed non-invasively by cardio impedance technology [ Time Frame: The intervention will be performed in one visit. During the visit patients will perform 2 trials lasting for 20 minutes each. The outcome 5 will be assessed at rest, at the 20th minute of cycling and 5 minutes post cycling at each trial. ]
    Change from baseline in cardiac output at end of exercise and recovery from exercise from resting breathing.



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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female aged 40 years or older.
  2. Current or previous smoking history: 10 or more pack years.
  3. Spirometry confirmed stable COPD (GOLD stages II-IV) under optimal medical therapy.
  4. Exhibit substantial exercise-induced dynamic hyperinflation (ΔIC baseline > 0,150 L)

Exclusion Criteria:

  1. Orthopaedic, neurological or other concomitant diseases that significantly impair normal biomechanical movement patterns, as judged by the investigator.
  2. Moderate or severe COPD exacerbation within 6 weeks.
  3. Unstable cardiac arrhythmia.
  4. Unstable ischaemic heart disease, including myocardial infarction within 6 weeks.
  5. Moderate or severe aortic stenosis or hypertrophic obstructive cardiomyopathy.
  6. Uncontrolled hypertension.
  7. Uncontrolled hypotension (SBP<85mmHg).
  8. Uncontrolled diabetes.
  9. Intolerance of the VitaBreath device.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03848819


Contacts
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Contact: Stephen Bourke, Professor 01912934026 stephen.bourke@NHCT.nhs.uk
Contact: Ioannis Vogiatzis, Professor 01913495446 ioannis.vogiatzis@northumbria.ac.uk

Locations
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United Kingdom
Northumbria University Not yet recruiting
Newcastle upon Tyne, United Kingdom, NE1 8ST
Contact: Ioannis Vogiatzis, Professor    1913495446    ioannis.vogiatzis@northumbria.ac.uk   
Sponsors and Collaborators
Northumbria University
North Tyneside General Hospital

Additional Information:
Publications:

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Responsible Party: Northumbria University
ClinicalTrials.gov Identifier: NCT03848819     History of Changes
Other Study ID Numbers: 259201
First Posted: February 21, 2019    Key Record Dates
Last Update Posted: February 21, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Northumbria University:
Chronic Obstructive Pulmonary Disease
Dynamic Hyperinflation

Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases