NCT00866541

Brief Summary

Flow proportional pressure support (FPPS) is a new mode of spontaneous breathing assistance. In patients with increased respiratory resistance the role of FPPS in comparison with the pressure support assist breathing mode is still unclear. In this study the investigators evaluate objective and subjective measured data in healthy volunteers with artificial increased resistance and FPPS breathing assistance.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
20

participants targeted

Target at P25-P50 for not_applicable healthy

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

January 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 19, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 20, 2009

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Last Updated

March 20, 2009

Status Verified

March 1, 2009

Enrollment Period

11 months

First QC Date

March 19, 2009

Last Update Submit

March 19, 2009

Conditions

Keywords

resistanceflow proportional pressure supportpressure support ventilationvolunteersassistant breathingbreathing comfort and objective breathing data

Outcome Measures

Primary Outcomes (1)

  • pressure support

    3 years

Study Arms (1)

volunteers

EXPERIMENTAL

artificial increased respiratory resistance

Device: artificial increased resistance (flow proportional pressure support)

Interventions

respiratory resistance is increased by interpose of an artificial resistance tool in the in- and expiratory airways of the mechanical respirator

volunteers

Eligibility Criteria

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

You may qualify if:

  • age over 18 years
  • ASA I and II

You may not qualify if:

  • refusal of written informed consent
  • chronic respiratory or cardiac diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center Freiburg

Freiburg im Breisgau, 79106, Germany

RECRUITING

Related Publications (4)

  • Mols G, Vetter T, Haberthur C, Geiger K, Guttmann J. Breathing pattern and perception at different levels of volume assist and pressure support in volunteers. Crit Care Med. 2001 May;29(5):982-8. doi: 10.1097/00003246-200105000-00018.

    PMID: 11378608BACKGROUND
  • Mols G, von Ungern-Sternberg B, Rohr E, Haberthur C, Geiger K, Guttmann J. Respiratory comfort and breathing pattern during volume proportional assist ventilation and pressure support ventilation: a study on volunteers with artificially reduced compliance. Crit Care Med. 2000 Jun;28(6):1940-6. doi: 10.1097/00003246-200006000-00042.

    PMID: 10890645BACKGROUND
  • Mols G, Rohr E, Benzing A, Haberthur C, Geiger K, Guttmann J. Breathing pattern associated with respiratory comfort during automatic tube compensation and pressure support ventilation in normal subjects. Acta Anaesthesiol Scand. 2000 Mar;44(3):223-30. doi: 10.1034/j.1399-6576.2000.440302.x.

    PMID: 10714832BACKGROUND
  • Guttmann J, Bernhard H, Mols G, Benzing A, Hofmann P, Haberthur C, Zappe D, Fabry B, Geiger K. Respiratory comfort of automatic tube compensation and inspiratory pressure support in conscious humans. Intensive Care Med. 1997 Nov;23(11):1119-24. doi: 10.1007/s001340050467.

    PMID: 9434916BACKGROUND

Study Officials

  • Daniel Steinmann, MD

    University Medical Center Freiburg

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 19, 2009

First Posted

March 20, 2009

Study Start

January 1, 2009

Primary Completion

December 1, 2009

Last Updated

March 20, 2009

Record last verified: 2009-03

Locations