Flow Proportional Pressure Support in Volunteers

Healthy Clinical Trial

Official title:

Flow Proportional Pressure Support as a New Mode of Spontaneous Breathing Assist - Evaluation of Objective and Subjective Measured Data in Volunteers

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00866541
• Other study ID #: 327/07
• Status: Recruiting
• Phase: N/A
• First received: March 19, 2009
• Last updated: March 19, 2009
• Start date: January 2009

Study information

• Verified date: March 2009
• Source: University Hospital Freiburg
• Contact: Daniel Steinmann, MD
• Phone: 0049 761 270 2329
• Email: daniel.steinmann[@]uniklinik-freiburg.de
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• age over 18 years

• ASA I and II

Exclusion Criteria:

• refusal of written informed consent

• chronic respiratory or cardiac diseases

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy

Intervention

Device:
• artificial increased resistance (flow proportional pressure support)
respiratory resistance is increased by interpose of an artificial resistance tool in the in- and expiratory airways of the mechanical respirator

Locations

Country	Name	City	State
Germany	University Medical Center Freiburg	Freiburg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Freiburg

Country where clinical trial is conducted

Germany, 

References & Publications (4)

Guttmann J, Bernhard H, Mols G, Benzing A, Hofmann P, Haberthür 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. — View Citation

Mols G, Rohr E, Benzing A, Haberthür 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. — View Citation

Mols G, Vetter T, Haberthür 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. — View Citation

Mols G, von Ungern-Sternberg B, Rohr E, Haberthür 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pressure support		3 years	No