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

Primary Purpose

COPD Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
nHF
BiPAP
Sponsored by
University of Leipzig
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COPD Chronic Obstructive Pulmonary Disease focused on measuring COPD, nHF, BiPAP

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Klinik Donaustauf, Zentrum für Pneumologie
  • Asklepios Fachkliniken München-Gauting, Klinik für Intensivmedizin und Langzeitbeatmung
  • Klinikum Nürnberg Nord, Medizinische Klinik 3, Schwerpunkt Pneumologie, Allergologie, Schlafmedizin
  • RoMed Klinikum Rosenheim, Medizinische Klinik III, Pneumologie
  • Marienkrankenhaus Kassel gGmbH, Medizinische Klinik / Pneumologie
  • Evangelisches Krankenhaus Göttingen-Weende gGmbH, Abteilung für Pneumologie
  • Fachkrankenhaus Kloster Grafschaft GmbH, Schlafmedizin & häusliche Beatmung
  • Diakonisches Werk Bethanien e.V, Klinik für Pneumologie
  • Universitätsklinikum Leipzig, Department für Innere Medizin, Neurologie und Dermatologie
  • Zentralklinik Bad Berka GmbH, Klinik für Pneumologie
  • Evangelisches Krankenhaus Bergisch Gladbach, Pneumologie
  • HELIOS Klinikum Emil von Behring, Klinik für Pneumologie
  • Asklepios Klinik Harburg, Lungenheilkunde (Pneumologie) im Thoraxzentrum, Sektion Pneumologische Intensiv- u. Beatmungsmedizin
  • Waldburg-Zeil Kliniken, Fachkliniken Wangen, Lungenzentrum Süd-West

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

BiPAP breathing support

nHF / TNI breathing support

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

difference in absolute change of capillary pCO2 (partial pressure of carbon dioxide ) compared with baseline
frequency of occurrence of normocapnia after intervention
Normocapnia is therefore defined as capillary pCO2 <= 45 mmHg
difference of the relative and absolute change of capillary pCO2 compared with baseline
difference of the absolute change of SaO2 (arterial oxygen saturation) compared with baseline
difference of the absolute and relative change of base excess compared with baseline
difference of the values of base excess after treatment with nHF (nasal high-flow) and of base excess after treatment with BiPAP
difference of the absolute change of HCO3- (hydrogen carbonate / bicarbonate) compared with baseline
difference of HCO3- after treatment with nHF and of HC03- after treatment with BiPAP
difference of P0,1 after treatment with nHF and of P0,1 after treatment with BiPAP
difference of PImax after treatment with nHF and of PImax (maximal inspiratory pressure) after treatment with BiPAP
difference of P0,1/PImax after treatment with nHF and of P0,1/PImax after treatment with BiPAP
difference of the absolute change of the results of the 6-minutes walking test compared with baseline
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)
frequency of occurrence and type of adverse events under trial therapy (both arms)
difference of the values of user-friendliness of both devices
difference of the time both devices were used

Full Information

First Posted
September 16, 2013
Last Updated
November 14, 2018
Sponsor
University of Leipzig
Collaborators
TNI Medical AG
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1. Study Identification

Unique Protocol Identification Number
NCT02007772
Brief Title
Effectiveness of TNI vs. BiPAP in Chronic Global Insufficiency in COPD Patients
Acronym
TIBICO
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 Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
July 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Leipzig
Collaborators
TNI Medical AG

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD Chronic Obstructive Pulmonary Disease
Keywords
COPD, nHF, BiPAP

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
105 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BiPAP breathing support
Arm Type
Active Comparator
Arm Description
BiPAP is used over a period of 6 weeks (outpatient)
Arm Title
nHF / TNI breathing support
Arm Type
Experimental
Arm Description
nasal high-flow is used over a period of 6 weeks (outpatient)
Intervention Type
Device
Intervention Name(s)
nHF
Other Intervention Name(s)
nasal high-flow
Intervention Description
nasal high-flow is used over a period of 6 weeks (outpatient)
Intervention Type
Device
Intervention Name(s)
BiPAP
Intervention Description
BiPAP is used over a period of 6 weeks (outpatient)
Primary Outcome Measure Information:
Title
difference in capillary CO2 carbon dioxide
Description
The primary endpoint is the difference of the capillary pC02 between the treatment with nasal high-flow compared with the baseline value.
Time Frame
Baseline, 6 weeks, 12 weeks
Secondary Outcome Measure Information:
Title
difference in absolute change of capillary pCO2 (partial pressure of carbon dioxide ) compared with baseline
Time Frame
Baseline, 6 weeks, 12 weeks
Title
frequency of occurrence of normocapnia after intervention
Description
Normocapnia is therefore defined as capillary pCO2 <= 45 mmHg
Time Frame
Baseline, 6 weeks, 12 weeks
Title
difference of the relative and absolute change of capillary pCO2 compared with baseline
Time Frame
Baseline, 6 weeks, 12 weeks
Title
difference of the absolute change of SaO2 (arterial oxygen saturation) compared with baseline
Time Frame
Baseline, 6 weeks, 12 weeks
Title
difference of the absolute and relative change of base excess compared with baseline
Time Frame
Baseline, 6 weeks, 12 weeks
Title
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
Title
difference of the absolute change of HCO3- (hydrogen carbonate / bicarbonate) compared with baseline
Time Frame
baseline, 6 weeks, 12 weeks
Title
difference of HCO3- after treatment with nHF and of HC03- after treatment with BiPAP
Time Frame
baseline, 6 weeks, 12 weeks
Title
difference of P0,1 after treatment with nHF and of P0,1 after treatment with BiPAP
Time Frame
baseline, 6 weeks, 12 weeks
Title
difference of PImax after treatment with nHF and of PImax (maximal inspiratory pressure) after treatment with BiPAP
Time Frame
baseline, 6 weeks, 12 weeks
Title
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
Title
difference of the absolute change of the results of the 6-minutes walking test compared with baseline
Time Frame
baseline, 6 weeks, 12 weeks
Title
difference of the absolute change of the disease-specific quality of life compared to baseline
Description
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)
Time Frame
baseline, 6 weeks, 12 weeks
Title
frequency of occurrence and type of adverse events under trial therapy (both arms)
Time Frame
baseline, 6 weeks, 12 weeks
Title
difference of the values of user-friendliness of both devices
Time Frame
baseline, 6 weeks, 12 weeks
Title
difference of the time both devices were used
Time Frame
baseline, 6 weeks, 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jens Braeunlich, Dr.
Organizational Affiliation
Medical Faculty University Leipzig
Official's Role
Study Chair
Facility Information:
Facility Name
Klinik Donaustauf, Zentrum für Pneumologie
City
Donaustauf
State/Province
Bayern
ZIP/Postal Code
93093
Country
Germany
Facility Name
Asklepios Fachkliniken München-Gauting, Klinik für Intensivmedizin und Langzeitbeatmung
City
Muenchen-Gauting
State/Province
Bayern
ZIP/Postal Code
82131
Country
Germany
Facility Name
Klinikum Nürnberg Nord, Medizinische Klinik 3, Schwerpunkt Pneumologie, Allergologie, Schlafmedizin
City
Nürnberg
State/Province
Bayern
ZIP/Postal Code
90419
Country
Germany
Facility Name
RoMed Klinikum Rosenheim, Medizinische Klinik III, Pneumologie
City
Rosenheim
State/Province
Bayern
ZIP/Postal Code
83022
Country
Germany
Facility Name
Marienkrankenhaus Kassel gGmbH, Medizinische Klinik / Pneumologie
City
Kassel
State/Province
Hessen
ZIP/Postal Code
34127
Country
Germany
Facility Name
Evangelisches Krankenhaus Göttingen-Weende gGmbH, Abteilung für Pneumologie
City
Bovenden
State/Province
Niedersachsen
ZIP/Postal Code
37120
Country
Germany
Facility Name
Fachkrankenhaus Kloster Grafschaft GmbH, Schlafmedizin & häusliche Beatmung
City
Schmallenberg
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
57392
Country
Germany
Facility Name
Diakonisches Werk Bethanien e.V, Klinik für Pneumologie
City
Solingen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
42699
Country
Germany
Facility Name
Universitätsklinikum Leipzig, Department für Innere Medizin, Neurologie und Dermatologie
City
Leipzig
State/Province
Sachsen
ZIP/Postal Code
04107
Country
Germany
Facility Name
Zentralklinik Bad Berka GmbH, Klinik für Pneumologie
City
Bad Berka
State/Province
Thueringen
ZIP/Postal Code
99437
Country
Germany
Facility Name
Evangelisches Krankenhaus Bergisch Gladbach, Pneumologie
City
Bergisch Gladbach
ZIP/Postal Code
51465
Country
Germany
Facility Name
HELIOS Klinikum Emil von Behring, Klinik für Pneumologie
City
Berlin
ZIP/Postal Code
14165
Country
Germany
Facility Name
Asklepios Klinik Harburg, Lungenheilkunde (Pneumologie) im Thoraxzentrum, Sektion Pneumologische Intensiv- u. Beatmungsmedizin
City
Hamburg
ZIP/Postal Code
21079
Country
Germany
Facility Name
Waldburg-Zeil Kliniken, Fachkliniken Wangen, Lungenzentrum Süd-West
City
Wangen im Allgäu
ZIP/Postal Code
88239
Country
Germany

12. IPD Sharing Statement

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

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