NCT01788345

Brief Summary

The purpose of this study is to determine whether the new Boussignac-system of non-invasive ventilation is as good as the conventional non-invasive System in patients presenting with acute hypercapnic respiratory failure.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

February 1, 2013

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

February 7, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 11, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

February 11, 2013

Status Verified

February 1, 2013

Enrollment Period

6 months

First QC Date

February 7, 2013

Last Update Submit

February 7, 2013

Conditions

Acute-on-chronic Respiratory Failure

Keywords

non-invasion ventilationBoussignac

Outcome Measures

Primary Outcomes (1)

  • Sinking pCO2

    6 months

Study Arms (1)

non-invasive ventilation

EXPERIMENTAL
Other: non- invasive ventilation

Interventions

non- invasive ventilationOTHER

non-invasive bi-level ventilation with IPAP and EPAP.

Also known as: Boussignac
non-invasive ventilation

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ,25 ≤ pH ≤ 7,35
  • PaCO2 ≥ 45 mmHg

You may not qualify if:

  • pH \< 7,24
  • incapable of collaboration

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

RoMed Klinikum Rosenheim

Rosenheim, Bavarian, 83022, Germany

Location

MeSH Terms

Interventions

Noninvasive Ventilation

Intervention Hierarchy (Ancestors)

Respiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Study Officials

  • Stephan Budweiser, PD

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 7, 2013

First Posted

February 11, 2013

Study Start

February 1, 2013

Primary Completion

August 1, 2013

Study Completion

December 1, 2013

Last Updated

February 11, 2013

Record last verified: 2013-02

Locations

DE(1)