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

NCT ID: NCT02007772

Last Updated: 2018-11-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 105 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2017-07-31

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.

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.

Conditions

COPD Chronic Obstructive Pulmonary Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BiPAP breathing support

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

Group Type: ACTIVE_COMPARATOR

nHF

Intervention Type: DEVICE

nasal high-flow is used over a period of 6 weeks (outpatient)

BiPAP

Intervention Type: DEVICE

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

nHF / TNI breathing support

nasal high-flow is used over a period of 6 weeks (outpatient)

Group Type: EXPERIMENTAL

nHF

Intervention Type: DEVICE

nasal high-flow is used over a period of 6 weeks (outpatient)

BiPAP

Intervention Type: DEVICE

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

Interventions

nHF

nasal high-flow is used over a period of 6 weeks (outpatient)

Intervention Type: DEVICE

BiPAP

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

Intervention Type: DEVICE

Other Intervention Names

nasal high-flow

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

TNI Medical AG

INDUSTRY

Sponsor Role: collaborator

University of Leipzig

OTHER

Sponsor Role: lead

Responsible Party

Jens Bräunlich, MD

Dr. Jens Braeunlich

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jens Braeunlich, Dr.

Role: STUDY_CHAIR

Medical Faculty University Leipzig

Locations

Klinik Donaustauf, Zentrum für Pneumologie

Donaustauf, Bavaria, Germany

Asklepios Fachkliniken München-Gauting, Klinik für Intensivmedizin und Langzeitbeatmung

Muenchen-Gauting, Bavaria, Germany

Klinikum Nürnberg Nord, Medizinische Klinik 3, Schwerpunkt Pneumologie, Allergologie, Schlafmedizin

Nuremberg, Bavaria, Germany

RoMed Klinikum Rosenheim, Medizinische Klinik III, Pneumologie

Rosenheim, Bavaria, Germany

Marienkrankenhaus Kassel gGmbH, Medizinische Klinik / Pneumologie

Kassel, Hesse, Germany

Evangelisches Krankenhaus Göttingen-Weende gGmbH, Abteilung für Pneumologie

Bovenden, Lower Saxony, Germany

Fachkrankenhaus Kloster Grafschaft GmbH, Schlafmedizin & häusliche Beatmung

Schmallenberg, North Rhine-Westphalia, Germany

Diakonisches Werk Bethanien e.V, Klinik für Pneumologie

Solingen, North Rhine-Westphalia, Germany

Universitätsklinikum Leipzig, Department für Innere Medizin, Neurologie und Dermatologie

Leipzig, Saxony, Germany

Zentralklinik Bad Berka GmbH, Klinik für Pneumologie

Bad Berka, Thuringia, Germany

Evangelisches Krankenhaus Bergisch Gladbach, Pneumologie

Bergisch Gladbach, , Germany

HELIOS Klinikum Emil von Behring, Klinik für Pneumologie

Berlin, , Germany

Asklepios Klinik Harburg, Lungenheilkunde (Pneumologie) im Thoraxzentrum, Sektion Pneumologische Intensiv- u. Beatmungsmedizin

Hamburg, , Germany

Waldburg-Zeil Kliniken, Fachkliniken Wangen, Lungenzentrum Süd-West

Wangen, , Germany

Countries

Germany

Other Identifiers

TIBICO

Identifier Type: -

Identifier Source: org_study_id