NCT01090544

Brief Summary

The purpose of this study is to determine wether transnasal insufflation as an alternate form of breathing support for COPD patients will lead to improvement of their medical condition.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2009

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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, 2009

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 19, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 22, 2010

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

September 30, 2010

Status Verified

September 1, 2010

Enrollment Period

6 months

First QC Date

March 19, 2010

Last Update Submit

September 29, 2010

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

COPDTNIPaCO2

Outcome Measures

Primary Outcomes (1)

  • partial pressure of carbon dioxide (PaCO2) decrease

    PaCO2 is measured before and after applying TNI, and a PaCO2 decrease is supposed to be assessed.

    3 hours

Secondary Outcomes (1)

  • Breathing Frequency

    3 hours

Interventions

Nasal InsufflationDEVICE

Breathing therapy

Also known as: TNI 20 oxy

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • COPD GOLD IV
  • PCO2 \> 50 mmHg
  • competent patients
  • stable respiratory situation

You may not qualify if:

  • serious acute diseases
  • hypercapnic decompensation pH \< 7,30

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Helios Klinik Hagen Ambrock

Hagen, North Rhine-Westphalia, 58091, Germany

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

  • Georg Nilius, MD

    Helios Klinik Hagen Ambrock

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 19, 2010

First Posted

March 22, 2010

Study Start

December 1, 2009

Primary Completion

June 1, 2010

Study Completion

September 1, 2010

Last Updated

September 30, 2010

Record last verified: 2010-09

Locations

DE(1)