Studies provide statistically significant evidence of the effectiveness of high-frequency chest wall oscillation administered via The Vest* System.St. Elisabeth Ziekenhuis Tilburg wants to demonstrate the effectiveness of HFCWO on ventilator-…
ID
Source
Brief title
Condition
- Bronchial disorders (excl neoplasms)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary study parameters are:
*age
*sex
*primary diagnosis
*APACHE-score
*Ventilator-mode
*FiO2
*Inspir./ expir. relation
*mandatory breaths
*Expired minute volume and tidal volume
*Peak airway pressure
*positive end-expiratiore pressure
*SaO2
*PeCO2
*Dynamic compliance
*Mean art. pressure (MAP)
*Hartrate
*bodytemperature
*suction frequency
*x-ray diagnosis
*bronchoscopic suction
*transfer to an other unit
*Leukocyte count
* use of antibiotics
Measuringmoments:
o T-0 = 1th measuringmoment, immediately before start intervention
o T-1 = 2th measuringmoment, immediately after finish intervention
o T-2 = 3th measuringmoment, 1 hour after intervention
Secondary outcome
not applicable
Background summary
Critically ill patients who needs to be ventilated are unable te move
spontaneously.
The are nursed in the supine position for extended periods of time.
Immobilisation may occur significant effects in the respiratory system.
Rechearch demonstrate that an effect of prolonged immobilization is
atelectasis, accumulation of mucus.
Atelectasis results in development of a shunt with attendant hypoxemia.
The pooled and stagnant secretions may act as a nidus for bacterial
proliferation, culminating in nosocomial pneumonia.
Treatment of atelectasis involves positive end-expiratory pressure, postural
drainage and manual hyperinsuflation.
In patients with nonresolving atelectasis, bronchoscopic suctioning may be
resorted to.
Bronchoscopy is an invasive and expensive procedure.
Patients with cystic fibrosis also risks to develop atelectasis.
Studies provide statistically significant evidence of the effectiveness of
high-frequency chest wall oscillation (HFCWO)administered via The Vest* System.
Study objective
Studies provide statistically significant evidence of the effectiveness of
high-frequency chest wall oscillation administered via The Vest* System.
St. Elisabeth Ziekenhuis Tilburg wants to demonstrate the effectiveness of
HFCWO on ventilator-dependent patients.
Objective:
Effect of high-frequency chest wall oscillation and manual hyperinflation on
the resolution of atelectasis in ventilated patients.
Study design
A prospective, randomized, experimentally, single center study.
Intervention
Patients who meets the entry criteria and agree to participate in the study
will be split up by randomisation.
10 Patients will be the intervention group and treaded with The Vest* therapy
and 10 patients treated with postural drainage and manual hyperinflation.
The intervention group will receive an inflatable vest connected by two tubes
to a small air-pulse generator.
The air-pulse generator rapidly inflates and deflates the vest, gently
compressing and releasing the chest wall up to 20 times per second during 20
minutes, 3 times a day.
This process creates mini-coughs that is dislogde mucus from the bronchial
walls, increase mobilization, and move it along toward central airways.Once the
mucus has moved from the smaller to larger airways, it can be easily removed by
suctioning.
Both treatments will end when the atelectasis are not visible any more on the
chest radiograph or maximally 3 days.
In patients with nonresolving atelectasis after 3 days of treatment,
bronchoscopic suctioning will be resorted to.
Study burden and risks
The Vest* System may have a negative influence on the ventilation or
hemodynamics.
The Vest* System is widely accepted and prescribed to treat secretion-related
pulmonary complications in more than 470 diseases and conditions, including
muscular dystrophy, spinal cord injury, chronic obstructive pulmonary disease
(COPD), multiple sclerosis (MS), cerebral palsy (CP) and cystic fibrosis (CF).
The Vest* System is also being used to maintain healthy lung function in
post-operative, ICU and post-lungtransplantation patients.
Atelectasis is difficult to manage and can lead to severe pulmonary
complications.
The Vest* System demonstrate the efficacy and safety for a variety of patients
with high risks of secretion-related pulmonary complications such as
atelectasis without annoying side effects.
Maybe it also demonstrate his efficacy and safety for ventilator-dependent
patients with atelectasis.
Ventilator-dependent patients are monitored constantly and every minimum change
in state of health will be noticed and responded adequately.
Hilvarenbeekseweg 60
5022GC Tilburg
Nederland
Hilvarenbeekseweg 60
5022GC Tilburg
Nederland
Listed location countries
Age
Inclusion criteria
patients older than 18 years
Atelectasis visible radiographically
Informed consent
Exclusion criteria
Patients with coagulationproblems
Patients with cancer and metastasis in the thorax area
Patients with spinal column fracture
Patients with spinal cord injury
Patients with recent rib fracture
Patients with high intracerebal pressure
Patients who are bleeding
Patients with open wounds at the thoracal area
Patients with thoraxtubes
Restless patients
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL15572.008.06 |