Trial document
This trial has been registered retrospectively.
DRKS00000449
Trial Description
Title
Oxygenation during noninvasive ventilation: active valve- versus leak-circuit
Trial Acronym
[---]*
URL of the Trial
[---]*
Brief Summary in Lay Language
The current study investigates the impact of different ventilatory circuits in home mechanical noninvasive ventialtion. Here, differences could be expected by different expiratory valves and the impact of leaks during ventilation.
Brief Summary in Scientific Language
The current study investigates the impact of different ventilatory circuits in home mechanical noninvasive ventialtion. Here, differences of oxygen fraction (FiO2) of the inhaled air are firstly analyzed in different ventilatory circuits. Secondly adding artificial leaks close to the face mask. Ventilator settings and supplemental oxygen flow are not changed analyzing the different study settups. Measurements are performed at daytime noninvasive ventilation in awake patients.
Organizational Data
- DRKS00000449
- 2010/10/05
- 2010/10/05
- yes
- Approved
- 319/09, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
Secondary IDs
- UKF002101 (Register klinischer Studien des Universitätsklinikums Freiburg)
Health Condition or Problem studied
- J96.1 - Chronic respiratory failure
Interventions/Observational Groups
- active valve circuit with and without an artficial leak
- leak circuit with and without an artficial leak
Characteristics
- Interventional
- [---]*
- Randomized controlled trial
- Open (masking not used)
- [---]*
- Active control
- Treatment
- Crossover
- N/A
- [---]*
Primary Outcome
Difference of FiO2 at FiO2-sensor 2 (at the interface) between active valve circuit and leak circuit
Secondary Outcome
Mean transcutaneous PCO2, oxygen saturation (SaO2), Subjective ventilation quality
Countries of Recruitment
- Germany
Locations of Recruitment
- [---]*
Recruitment
- Actual
- 2009/12/11
- 20
- Monocenter trial
- National
Inclusion Criteria
- Both, male and female
- 18 Years
- 90 Years
Additional Inclusion Criteria
Patients with stable hypercapnic chronic respiratory failure (CRF) on NPPV with supplemental oxygen of at least 2 L/min will be enrolled. Patients are referred to the Department of Pneumology of the University Hospital Freiburg for a routine control visit of their NPPV.
Exclusion Criteria
Patients who presented with an acute exacerbation (respiratory frequency 30 breaths/min, pH <7.35 or clinical signs of infection), those planned for weaning from invasive ventilation or those who had been intubated or tracheostomised during the previous 3 months will be excluded.
Addresses
-
start of 1:1-Block address primary-sponsor
- Universitätsklinikum Freiburg, Abteilung Innere Medizin V - Pneumologie
- Mr. Prof. Dr. Wolfram Windisch
- Killianstr. 5
- 79106 Freiburg
- Germany
end of 1:1-Block address primary-sponsorstart of 1:1-Block address contact primary-sponsor- 00497612703731
- 00497612703704
- wolfram.windisch at uniklinik-freiburg.de
- http://www.uniklinik-freiburg.de
end of 1:1-Block address contact primary-sponsor -
start of 1:1-Block address scientific-contact
- Universitätsklinik Freiburg Innere Medizin V - Pneumologie
- Mr. Dr. Jan Hendrik Storre
- Killianstr. 5
- 79106 Freiburg
- Germany
end of 1:1-Block address scientific-contactstart of 1:1-Block address contact scientific-contact- 0049 761 270 3401
- 0049 761 270 3704
- jan.storre at uniklinik-freiburg.de
- http://www.uniklinik-freiburg.de
end of 1:1-Block address contact scientific-contact -
start of 1:1-Block address public-contact
- Universitätsklinik Freiburg Innere Medizin V - Pneumologie
- Mr. Dr. Jan Hendrik Storre
- Killianstr. 5
- 79106 Freiburg
- Germany
end of 1:1-Block address public-contactstart of 1:1-Block address contact public-contact- 0049 761 270 3401
- 0049 761 270 3704
- jan.storre at uniklinik-freiburg.de
- http://www.uniklinik-freiburg.de
end of 1:1-Block address contact public-contact
Sources of Monetary or Material Support
-
start of 1:1-Block address materialSupport
- Universitätsklinikum Freiburg, Abteilung Innere Medizin V - Pneumologie
- Mr. Prof. Dr. Wolfram Windisch
- Killianstr. 5
- 79106 Freiburg
- Germany
end of 1:1-Block address materialSupportstart of 1:1-Block address contact materialSupport- 00497612703731
- 00497612703704
- wolfram.windisch at uniklinik-freiburg.de
- http://www.uniklinik-freiburg.de
end of 1:1-Block address contact materialSupport
Status
- Recruiting complete, follow-up complete
- 2010/08/05