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Effectiveness of TNI vs. BiPAP in Chronic Global Insufficiency in COPD Patients (TIBICO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02007772
Recruitment Status : Completed
First Posted : December 11, 2013
Last Update Posted : November 15, 2018
Sponsor:
Collaborator:
TNI Medical AG
Information provided by (Responsible Party):
Jens Bräunlich, MD, University of Leipzig

Brief Summary:
The purpose of this trial ist to investigate the difference of the efficacy of two systems for breath support in patients with COPD.

Condition or disease Intervention/treatment Phase
COPD Chronic Obstructive Pulmonary Disease Device: nHF Device: BiPAP Not Applicable

Detailed Description:

The trial consists of 12 weeks of therapy that is divided into two sections. In the first 6-week section patients receive treatment with either TNI or BiPAP and in the second 6-week section treatment is changed. The starting therapy is allocated to the patients via randomisation and should be started directly after the baseline visit.

The treatment and the follow-up period end with the second visit after the second treatment section and the patient decides which device he/she wants to use further.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 105 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effectiveness of TNI (Nasal High-flow) vs. BiPAP (Biphasic Positive Airway Pressure) in Chronic Global Insufficiency in COPD (Chronic Obstructive Pulmonary Disease) Patients
Study Start Date : June 2011
Actual Primary Completion Date : July 2017
Actual Study Completion Date : July 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: BiPAP breathing support
BiPAP is used over a period of 6 weeks (outpatient)
Device: nHF
nasal high-flow is used over a period of 6 weeks (outpatient)
Other Name: nasal high-flow

Device: BiPAP
BiPAP is used over a period of 6 weeks (outpatient)

Experimental: nHF / TNI breathing support
nasal high-flow is used over a period of 6 weeks (outpatient)
Device: nHF
nasal high-flow is used over a period of 6 weeks (outpatient)
Other Name: nasal high-flow

Device: BiPAP
BiPAP is used over a period of 6 weeks (outpatient)




Primary Outcome Measures :
  1. difference in capillary CO2 carbon dioxide [ Time Frame: Baseline, 6 weeks, 12 weeks ]
    The primary endpoint is the difference of the capillary pC02 between the treatment with nasal high-flow compared with the baseline value.


Secondary Outcome Measures :
  1. difference in absolute change of capillary pCO2 (partial pressure of carbon dioxide ) compared with baseline [ Time Frame: Baseline, 6 weeks, 12 weeks ]
  2. frequency of occurrence of normocapnia after intervention [ Time Frame: Baseline, 6 weeks, 12 weeks ]
    Normocapnia is therefore defined as capillary pCO2 <= 45 mmHg

  3. difference of the relative and absolute change of capillary pCO2 compared with baseline [ Time Frame: Baseline, 6 weeks, 12 weeks ]
  4. difference of the absolute change of SaO2 (arterial oxygen saturation) compared with baseline [ Time Frame: Baseline, 6 weeks, 12 weeks ]
  5. difference of the absolute and relative change of base excess compared with baseline [ Time Frame: Baseline, 6 weeks, 12 weeks ]
  6. difference of the values of base excess after treatment with nHF (nasal high-flow) and of base excess after treatment with BiPAP [ Time Frame: baseline, 6 weeks, 12 weeks ]
  7. difference of the absolute change of HCO3- (hydrogen carbonate / bicarbonate) compared with baseline [ Time Frame: baseline, 6 weeks, 12 weeks ]
  8. difference of HCO3- after treatment with nHF and of HC03- after treatment with BiPAP [ Time Frame: baseline, 6 weeks, 12 weeks ]
  9. difference of P0,1 after treatment with nHF and of P0,1 after treatment with BiPAP [ Time Frame: baseline, 6 weeks, 12 weeks ]
  10. difference of PImax after treatment with nHF and of PImax (maximal inspiratory pressure) after treatment with BiPAP [ Time Frame: baseline, 6 weeks, 12 weeks ]
  11. difference of P0,1/PImax after treatment with nHF and of P0,1/PImax after treatment with BiPAP [ Time Frame: baseline, 6 weeks, 12 weeks ]
  12. difference of the absolute change of the results of the 6-minutes walking test compared with baseline [ Time Frame: baseline, 6 weeks, 12 weeks ]
  13. difference of the absolute change of the disease-specific quality of life compared to baseline [ Time Frame: baseline, 6 weeks, 12 weeks ]
    Quality of life is measured by SGQR (The St George's Respiratory Questionnaire), SRI (Severe Respiratory Insufficiency Questionnaire), a VAS referring to the general health status and the Borg-Scale (CR 10)

  14. frequency of occurrence and type of adverse events under trial therapy (both arms) [ Time Frame: baseline, 6 weeks, 12 weeks ]
  15. difference of the values of user-friendliness of both devices [ Time Frame: baseline, 6 weeks, 12 weeks ]
  16. difference of the time both devices were used [ Time Frame: baseline, 6 weeks, 12 weeks ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • presence of COPD with chronic respiratory global insufficiency
  • chronic day-hypercapnia with pCO2 >= 50 mmHg and typical symptoms of ventilatory insufficiency OR patients with exacerbation (after abate of acute symptomatology) with documented hypercapnia >= 50 mmHG on preliminary findings
  • age 18 or older
  • the patient or caretaker must be able to operate the device after a specific training
  • patient must be willing to use the nHF-/BiPAP-device for the whole trial period for at least 5 hours/day
  • patient must be able to answer the questionnaires
  • written informed consent is obtained

Exclusion Criteria:

  • presence of acute respiratory insufficiency
  • exacerbation of type I or II in the last 4 weeks
  • conservative therapy including long-term oxygen therapy according to GOLD update 2011 is not exhausted
  • previous treatment with NIV (non-invasive ventilation) in the last 14 days
  • clinical instability or acute illness (e.g. acute myocardial infarction, tachycardial atrial fibrillation)
  • signs of cardial decompensation (e.g. edema in the lower limbs, pleural effusion)
  • other serious concomitant diseases, the assessment of eligibility is at the discretion of the investigator
  • contraindications for NIV
  • anamnestic suspicion or proven obstructive sleep apnea (OSA)
  • relevant systemic infections, assessment of eligibility is at the discretion of the investigator
  • BMI > 30
  • other additional pulmonary diseases of other genesis or diseases that affect breathing (e.g. mucoviscidosis, scoliosis, muscular diseases)
  • lack of compliance
  • participation in other interventional trials at the same time
  • pregnant or nursing women
  • fertile female patients without effective contraceptive measures during trial participation

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): NCT02007772


Locations
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Germany
Klinik Donaustauf, Zentrum für Pneumologie
Donaustauf, Bayern, Germany, 93093
Asklepios Fachkliniken München-Gauting, Klinik für Intensivmedizin und Langzeitbeatmung
Muenchen-Gauting, Bayern, Germany, 82131
Klinikum Nürnberg Nord, Medizinische Klinik 3, Schwerpunkt Pneumologie, Allergologie, Schlafmedizin
Nürnberg, Bayern, Germany, 90419
RoMed Klinikum Rosenheim, Medizinische Klinik III, Pneumologie
Rosenheim, Bayern, Germany, 83022
Marienkrankenhaus Kassel gGmbH, Medizinische Klinik / Pneumologie
Kassel, Hessen, Germany, 34127
Evangelisches Krankenhaus Göttingen-Weende gGmbH, Abteilung für Pneumologie
Bovenden, Niedersachsen, Germany, 37120
Fachkrankenhaus Kloster Grafschaft GmbH, Schlafmedizin & häusliche Beatmung
Schmallenberg, Nordrhein-Westfalen, Germany, 57392
Diakonisches Werk Bethanien e.V, Klinik für Pneumologie
Solingen, Nordrhein-Westfalen, Germany, 42699
Universitätsklinikum Leipzig, Department für Innere Medizin, Neurologie und Dermatologie
Leipzig, Sachsen, Germany, 04107
Zentralklinik Bad Berka GmbH, Klinik für Pneumologie
Bad Berka, Thueringen, Germany, 99437
Evangelisches Krankenhaus Bergisch Gladbach, Pneumologie
Bergisch Gladbach, Germany, 51465
HELIOS Klinikum Emil von Behring, Klinik für Pneumologie
Berlin, Germany, 14165
Asklepios Klinik Harburg, Lungenheilkunde (Pneumologie) im Thoraxzentrum, Sektion Pneumologische Intensiv- u. Beatmungsmedizin
Hamburg, Germany, 21079
Waldburg-Zeil Kliniken, Fachkliniken Wangen, Lungenzentrum Süd-West
Wangen im Allgäu, Germany, 88239
Sponsors and Collaborators
University of Leipzig
TNI Medical AG
Investigators
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Study Chair: Jens Braeunlich, Dr. Medical Faculty University Leipzig
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Responsible Party: Jens Bräunlich, MD, Dr. Jens Braeunlich, University of Leipzig
ClinicalTrials.gov Identifier: NCT02007772    
Other Study ID Numbers: TIBICO
First Posted: December 11, 2013    Key Record Dates
Last Update Posted: November 15, 2018
Last Verified: November 2018
Keywords provided by Jens Bräunlich, MD, University of Leipzig:
COPD, nHF, BiPAP
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases