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

COPD Chronic Obstructive Pulmonary Disease Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02007772
• Other study ID #: TIBICO
• Status: Completed
• Phase: N/A
• Start date: June 2011
• Est. completion date: July 2017

Study information

• Verified date: November 2018
• Source: University of Leipzig
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COPD Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Device:
• nHF
nasal high-flow is used over a period of 6 weeks (outpatient)
• BiPAP
BiPAP is used over a period of 6 weeks (outpatient)

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
University of Leipzig	TNI Medical AG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	difference in absolute change of capillary pCO2 (partial pressure of carbon dioxide ) compared with baseline		Baseline, 6 weeks, 12 weeks
Secondary	frequency of occurrence of normocapnia after intervention	Normocapnia is therefore defined as capillary pCO2 <= 45 mmHg	Baseline, 6 weeks, 12 weeks
Secondary	difference of the relative and absolute change of capillary pCO2 compared with baseline		Baseline, 6 weeks, 12 weeks
Secondary	difference of the absolute change of SaO2 (arterial oxygen saturation) compared with baseline		Baseline, 6 weeks, 12 weeks
Secondary	difference of the absolute and relative change of base excess compared with baseline		Baseline, 6 weeks, 12 weeks
Secondary	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
Secondary	difference of the absolute change of HCO3- (hydrogen carbonate / bicarbonate) compared with baseline		baseline, 6 weeks, 12 weeks
Secondary	difference of HCO3- after treatment with nHF and of HC03- after treatment with BiPAP		baseline, 6 weeks, 12 weeks
Secondary	difference of P0,1 after treatment with nHF and of P0,1 after treatment with BiPAP		baseline, 6 weeks, 12 weeks
Secondary	difference of PImax after treatment with nHF and of PImax (maximal inspiratory pressure) after treatment with BiPAP		baseline, 6 weeks, 12 weeks
Secondary	difference of P0,1/PImax after treatment with nHF and of P0,1/PImax after treatment with BiPAP		baseline, 6 weeks, 12 weeks
Secondary	difference of the absolute change of the results of the 6-minutes walking test compared with baseline		baseline, 6 weeks, 12 weeks
Secondary	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
Secondary	frequency of occurrence and type of adverse events under trial therapy (both arms)		baseline, 6 weeks, 12 weeks
Secondary	difference of the values of user-friendliness of both devices		baseline, 6 weeks, 12 weeks
Secondary	difference of the time both devices were used		baseline, 6 weeks, 12 weeks