Trial document




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  DRKS00012325

Trial Description

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Title

Comparison of a conventional non-invasive ventilation to a non-invasive pursed-lip breathing ventilation (PLBV) ventilation in advanced COPD

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Trial Acronym

[---]*

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URL of the Trial

http://lippenbremse.fz-borstel.de

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Brief Summary in Lay Language

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Brief Summary in Scientific Language

Pursed-lip breathing is a breathing technique that results in improved pulmonary deflation and reduction of trapped air volume. It requires active and conscious ventilation, therefore it cannot be performed when sleeping. The non-invasive ventilator FLO Vigaro (manufacturer: FLO Medizintechnik GmbH, 49328 Melle, Germany) is the first device with an integrated pursed-lip breathing ventilation mode (PLBV) facilitating the build-up of a dynamic positive pressure during expiration.
It can be assumed that implementing PLBV in patients with advanced COPD results in normalisation of ventilatory function with subsequent improved oxygenation, reduced hypercapnia and better exercise capacity. Reduced collapse of the small airways, fewer dystelectases and more effective mucus clearance can potentially reduce pulmonary dysbiosis and exacerbation rates. Subsequently, quality of life, number of hospital admissions, healthcare related costs and mortality rates may improve. In contrast to active pursed-lip breathing, the beneficial effects of PLBV may be achieved from nocturnal ventilation.
The most established surrogate marker for alveolar ventilation, capillary pCO2 is expected to drop in hypercapnic patients and remain within normal range in normocapnic patients. Due to normalised ventilation mechanics, these clinical and biochemical effects can be achieved with significantly lower inspiratory ventilation pressures, improving the patient’s compliance In contrast to conventional ventilation modes, PLBV does not apply a fixed positive pressure in expiration but adjusts airway resistance to the airflow. The dynamic pressure that is added to a constant PEEP can be adjusted as required. Thereby, PLBV augments the reduction of Auto-PEEP phenomena and improves pulmonary deflation.
This prospective, multicentre study aims to evaluate this ventilation mode in patients with severe COPD and pre-existing NIV ventilation. Patients in the control group keep their NIV device, patients in the intervention group will be treated with the new VIGARO NIV device in PLBV mode. The treatment duration is 3 months, followed by a 9 months follow-up period.

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Organizational Data

  •   DRKS00012325
  •   2017/08/14
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  •   yes
  •   Approved
  •   17-127, Ethik-Kommission Universität zu Lübeck Medizinische Fakultät des Universitätsklinikums Schleswig-Holstein
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Secondary IDs

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Health Condition or Problem studied

  •   COPD
  •   J44.9 -  Chronic obstructive pulmonary disease, unspecified
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Interventions/Observational Groups

  •   Treatment with pursed lip breathing ventilation NIV for 3 months (Vigaro NIV device)
  •   Treatment with standard NIV (Non-invasive Ventilation)
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Distance of the 6 minute walk test at 3 months

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Secondary Outcome

At 3 months therapy: NIV parameters (IPAP, PEEP), blood gas analysis (pCO2), number of hospital admissions

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
  • Medical Center 
  • University Medical Center 
  • University Medical Center 
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Recruitment

  •   Actual
  •   2018/02/26
  •   256
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   40   Years
  •   no maximum age
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Additional Inclusion Criteria

1. Age >40 years
2. COPD diagnosis known for at least 12 months
3. NIV therapy for at least 3 months
4. Regular use of NIV with extrapolated usage time of at least 700 hours / year
5. Current inspiratory NIV pressure ≥20 mbar
6. Patient understands the requirements of the study
7. Patient is able to follow the study protocol

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Exclusion Criteria

1.Current COPD exacerbation (is allowed 4 weeks after end of treatment)
2.Radiologically proven pneumonia within the past month
3.Other leading pulmonary illness
4.Tracheostomy
5.Pneumothorax
6.Pregnancy or lactation
7.BMI >35 kg/m²
8.Steroid therapy with >15 mg prednisolon daily for >1 month
9.Condition causing hypercapnia other than COPD
10.6MWT distance of >300 meters within the last 7 days
11.Previous therapy with the Vigaro NIV device
12.Weight loss of more than 5 kg / 12 months
13.Further criteria to exclude confounding factors

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Addresses

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    • Forschungszentrum Borstel
    • Parkallee 1-40
    • 23845  Borstel
    • Germany
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    • Forschungszentrum Borstel
    • Mr.  Dr. med.  Christian  Herzmann 
    • Parkallee 35
    • 23845  Borstel
    • Germany
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    • Forschungszentrum BorstelKlinisches Studienzentrum
    • Ms.  Vanessa  Schümann 
    • Parkallee 35
    • 23845  Borstel
    • Germany
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Sources of Monetary or Material Support

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    • Deutsches Zentrum für Lungenforschung, e.V.
    • Aulweg 130
    • 35392  Gießen
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.