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

NCT02007772 | Completed

• 1 other identifier: TIBICO
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 14

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.

Conditions

COPD Chronic Obstructive Pulmonary Disease

Keywords

COPD, nHF, BiPAP

Outcome Measures

Primary Outcomes (1)

• difference in capillary CO2 carbon dioxide

  The primary endpoint is the difference of the capillary pC02 between the treatment with nasal high-flow compared with the baseline value.

  Baseline, 6 weeks, 12 weeks

Secondary Outcomes (16)

• difference in absolute change of capillary pCO2 (partial pressure of carbon dioxide ) compared with baseline

  Baseline, 6 weeks, 12 weeks

• frequency of occurrence of normocapnia after intervention

  Baseline, 6 weeks, 12 weeks

• difference of the relative and absolute change of capillary pCO2 compared with baseline

  Baseline, 6 weeks, 12 weeks

• difference of the absolute change of SaO2 (arterial oxygen saturation) compared with baseline

  Baseline, 6 weeks, 12 weeks

• difference of the absolute and relative change of base excess compared with baseline

  Baseline, 6 weeks, 12 weeks

Study Arms (2)

BiPAP breathing support

ACTIVE COMPARATOR

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

Device: nHF; Device: BiPAP

nHF / TNI breathing support

EXPERIMENTAL

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

Device: nHF; Device: BiPAP

Interventions

nHF DEVICE

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

Also known as: nasal high-flow

BiPAP breathing support; nHF / TNI breathing support

BiPAP DEVICE

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

BiPAP breathing support; nHF / TNI breathing support

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Leipzig: lead
• TNI Medical AG: collaborator

Study Sites (14)

Klinik Donaustauf, Zentrum für Pneumologie

Donaustauf, Bavaria, 93093, Germany

Location

Asklepios Fachkliniken München-Gauting, Klinik für Intensivmedizin und Langzeitbeatmung

Muenchen-Gauting, Bavaria, 82131, Germany

Location

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

Nuremberg, Bavaria, 90419, Germany

Location

RoMed Klinikum Rosenheim, Medizinische Klinik III, Pneumologie

Rosenheim, Bavaria, 83022, Germany

Location

Marienkrankenhaus Kassel gGmbH, Medizinische Klinik / Pneumologie

Kassel, Hesse, 34127, Germany

Location

Evangelisches Krankenhaus Göttingen-Weende gGmbH, Abteilung für Pneumologie

Bovenden, Lower Saxony, 37120, Germany

Location

Fachkrankenhaus Kloster Grafschaft GmbH, Schlafmedizin & häusliche Beatmung

Schmallenberg, North Rhine-Westphalia, 57392, Germany

Location

Diakonisches Werk Bethanien e.V, Klinik für Pneumologie

Solingen, North Rhine-Westphalia, 42699, Germany

Location

Universitätsklinikum Leipzig, Department für Innere Medizin, Neurologie und Dermatologie

Leipzig, Saxony, 04107, Germany

Location

Zentralklinik Bad Berka GmbH, Klinik für Pneumologie

Bad Berka, Thuringia, 99437, Germany

Location

Evangelisches Krankenhaus Bergisch Gladbach, Pneumologie

Bergisch Gladbach, 51465, Germany

Location

HELIOS Klinikum Emil von Behring, Klinik für Pneumologie

Berlin, 14165, Germany

Location

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

Hamburg, 21079, Germany

Location

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

Wangen, 88239, Germany

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

• Jens Braeunlich, Dr.

  Medical Faculty University Leipzig

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Jens Braeunlich

Study Record Dates

• First Submitted: September 16, 2013
• First Posted: December 11, 2013
• Study Start: June 1, 2011
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: November 15, 2018

Record last verified: 2018-11

Locations

DE (14)