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

Effectiveness of TNI (Nasal High-flow) vs. BiPAP (Biphasic Positive Airway Pressure) in Chronic Global Insufficiency in COPD (Chronic Obstructive Pulmonary Disease) Patients

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

Study Overview

• Status: Completed
• Conditions: COPD Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Device: nHF; Device: BiPAP

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.

• Study Type: Interventional
• Enrollment (Actual): 105
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Bergisch Gladbach, Germany, 51465
    • Evangelisches Krankenhaus Bergisch Gladbach, Pneumologie
  • Berlin, Germany, 14165
    • HELIOS Klinikum Emil von Behring, Klinik für Pneumologie
  • Hamburg, Germany, 21079
    • Asklepios Klinik Harburg, Lungenheilkunde (Pneumologie) im Thoraxzentrum, Sektion Pneumologische Intensiv- u. Beatmungsmedizin
  • Wangen im Allgäu, Germany, 88239
    • Waldburg-Zeil Kliniken, Fachkliniken Wangen, Lungenzentrum Süd-West
  • Bayern
    • Donaustauf, Bayern, Germany, 93093
      • Klinik Donaustauf, Zentrum für Pneumologie
    • Muenchen-Gauting, Bayern, Germany, 82131
      • Asklepios Fachkliniken München-Gauting, Klinik für Intensivmedizin und Langzeitbeatmung
    • Nürnberg, Bayern, Germany, 90419
      • Klinikum Nürnberg Nord, Medizinische Klinik 3, Schwerpunkt Pneumologie, Allergologie, Schlafmedizin
    • Rosenheim, Bayern, Germany, 83022
      • RoMed Klinikum Rosenheim, Medizinische Klinik III, Pneumologie
  • Hessen
    • Kassel, Hessen, Germany, 34127
      • Marienkrankenhaus Kassel gGmbH, Medizinische Klinik / Pneumologie
  • Niedersachsen
    • Bovenden, Niedersachsen, Germany, 37120
      • Evangelisches Krankenhaus Göttingen-Weende gGmbH, Abteilung für Pneumologie
  • Nordrhein-Westfalen
    • Schmallenberg, Nordrhein-Westfalen, Germany, 57392
      • Fachkrankenhaus Kloster Grafschaft GmbH, Schlafmedizin & häusliche Beatmung
    • Solingen, Nordrhein-Westfalen, Germany, 42699
      • Diakonisches Werk Bethanien e.V, Klinik für Pneumologie
  • Sachsen
    • Leipzig, Sachsen, Germany, 04107
      • Universitätsklinikum Leipzig, Department für Innere Medizin, Neurologie und Dermatologie
  • Thueringen
    • Bad Berka, Thueringen, Germany, 99437
      • Zentralklinik Bad Berka GmbH, Klinik für Pneumologie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: nasal high-flow; Device: BiPAP; BiPAP is used over a period of 6 weeks (outpatient)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Normocapnia is therefore defined as capillary pCO2 <= 45 mmHg	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
difference of the values of base excess after treatment with nHF (nasal high-flow) and of base excess after treatment with BiPAP		baseline, 6 weeks, 12 weeks
difference of the absolute change of HCO3- (hydrogen carbonate / bicarbonate) compared with baseline		baseline, 6 weeks, 12 weeks
difference of HCO3- after treatment with nHF and of HC03- after treatment with BiPAP		baseline, 6 weeks, 12 weeks
difference of P0,1 after treatment with nHF and of P0,1 after treatment with BiPAP		baseline, 6 weeks, 12 weeks
difference of PImax after treatment with nHF and of PImax (maximal inspiratory pressure) after treatment with BiPAP		baseline, 6 weeks, 12 weeks
difference of P0,1/PImax after treatment with nHF and of P0,1/PImax after treatment with BiPAP		baseline, 6 weeks, 12 weeks
difference of the absolute change of the results of the 6-minutes walking test compared with baseline		baseline, 6 weeks, 12 weeks
difference of the absolute change of the disease-specific quality of life compared to baseline	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)	baseline, 6 weeks, 12 weeks
frequency of occurrence and type of adverse events under trial therapy (both arms)		baseline, 6 weeks, 12 weeks
difference of the values of user-friendliness of both devices		baseline, 6 weeks, 12 weeks
difference of the time both devices were used		baseline, 6 weeks, 12 weeks

Collaborators and Investigators

• Sponsor: University of Leipzig
• Collaborators: TNI Medical AG
• Investigators: Study Chair: Jens Braeunlich, Dr., Medical Faculty University Leipzig

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (ACTUAL): July 1, 2017
• Study Completion (ACTUAL): July 1, 2017

Study Registration Dates

• First Submitted: September 16, 2013
• First Submitted That Met QC Criteria: December 6, 2013
• First Posted (ESTIMATE): December 11, 2013

Study Record Updates

• Last Update Posted (ACTUAL): November 15, 2018
• Last Update Submitted That Met QC Criteria: November 14, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: COPD, nHF, BiPAP
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: TIBICO