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

University of Leipzig

Status: Completed

Conditions: COPD Chronic Obstructive Pulmonary Disease

Treatments: Device: nHF; Device: BiPAP

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02007772

TIBICO

Details and patient eligibility

About

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

Full 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.

Enrollment: 105 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

105 participants in 2 patient groups

BiPAP breathing support

Active Comparator group

Description:

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

Treatment:

Device: BiPAP

Device: nHF

nHF / TNI breathing support

Experimental group

Description:

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

Treatment:

Device: BiPAP

Device: nHF