NCT01693146

Brief Summary

Evaluation of Safety and Efficacy of Short time TNI Treatment in Patients with COPD and hypercapnia. Acute testing of oxygen demand using TNI vs. standard oxygen application in stable COPD patients with hypercapnia.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Dec 2011

Typical duration for phase_1

Geographic Reach
3 countries

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2011

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 14, 2012

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 26, 2012

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

September 26, 2012

Status Verified

September 1, 2012

Enrollment Period

2 years

First QC Date

September 14, 2012

Last Update Submit

September 25, 2012

Conditions

COPDHypercapnia

Keywords

OxygenHigh FlowCOPDHypercapnia

Outcome Measures

Primary Outcomes (1)

  • PaO2

    Change in the partial oxygen pressure in the arterial blood (blood gas analysis) at a defined oxygen flow rate (L/min)

    60 min

Secondary Outcomes (4)

  • O2%

    60 min

  • PaCO2

    60 min

  • AaDO2

    60 min

  • RV and TLC

    60 min

Study Arms (2)

Nasal insufflation of oxygen

ACTIVE COMPARATOR

Nasal insufflation of oxygen starting at at flow of 0.5 L/min.

Device: Nasal insufflation of oxygen

Nasal oxygen insufflation with a TNI® 20 oxy device

ACTIVE COMPARATOR

Device: TNI®20 oxy Nasal insufflation at a constant high flow of 15 L/min with oxygen addition starting at 0.5 L/min

Device: Nasal oxygen insufflation with a TNI® 20 oxy device

Interventions

Nasal oxygen insufflation with a TNI® 20 oxy deviceDEVICE

Nasal insufflation at a constant high flow of 15 L/min with oxygen addition starting at 0.5 L/min

Nasal oxygen insufflation with a TNI® 20 oxy device
Nasal insufflation of oxygenDEVICE

Nasal insufflation of oxygen starting at at flow of 0.5 L/min.

Nasal insufflation of oxygen

Eligibility Criteria

Age30 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • COPD patients with an indication for long-term oxygen therapy (LTOT)
  • Presence of hypercapnia at rest without oxygen supplementation (PaCO2 \> 45 mmHg)
  • Age 30 - 85 years
  • Functional GOLD class: COPD GOLD IV as defined by the following:
  • FEV1/FVC \< 70% and a Post-bronchodilator FEV1 \< 30% or FEV1 \< 50% and a PaO2 \< 60 mmHg and/or PaCO2 \> 50 mmHg

You may not qualify if:

  • Clinical instability of the patient
  • No lung function testing possible
  • Severe anaemia, defined by a haemoglobin \<8.5 G/L
  • Participation of the patient in any other ongoing study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Christian Kähler

Innsbruck, A-6020, Austria

RECRUITING

Pneumologie, Medizinische Klinik und Poliklinik I, University of Dresden

Dresden, D-01307, Germany

NOT YET RECRUITING

Klinik für Innere Medizin V, Universitätsklinikum Homburg, University of Homburg/Saar

Homburg, D-66424, Germany

RECRUITING

Klinik und Poliklinik für Pneumologie, Inselspital Berne, University of Berne

Bern, CH-3010, Switzerland

RECRUITING

Related Publications (1)

  • Vogelsinger H, Halank M, Braun S, Wilkens H, Geiser T, Ott S, Stucki A, Kaehler CM. Efficacy and safety of nasal high-flow oxygen in COPD patients. BMC Pulm Med. 2017 Nov 17;17(1):143. doi: 10.1186/s12890-017-0486-3.

    PMID: 29149867DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveHypercapnia

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms, RespiratorySigns and Symptoms

Study Officials

  • Christian M Kaehler, MD

    Medical University Innsbruck

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Christian M Kaehler, MD

CONTACT

004351250423255c.m.kaehler@i-med.ac.at

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
a.Univ.-Prod. Dr.

Study Record Dates

First Submitted

September 14, 2012

First Posted

September 26, 2012

Study Start

December 1, 2011

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

September 26, 2012

Record last verified: 2012-09

Locations

DE(2)AU(1)CH(1)