The hypothesis of this study is that variable pressure support ventilation reduces the duration of mechanical ventilation to non-variable (convention-al) pressure support ventilation.
ID
Source
Brief title
Condition
- Lower respiratory tract disorders (excl obstruction and infection)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Weaning time defined as time from randomization to successful extubation.
Secondary outcome
* total time of mechanical ventilation
* length of stay in the ICU and in-hospital
* mortality
* lung function
* patient comfort
* organ failure
* need for noninvasive ventilation and reintubation;
* number of interventions of the ICU personal in the mechanical ventilator;
* variability of respiratory parameters of the breathing pattern
Background summary
PSV is the most commonly used form of assisted ventilation, but can result in
reduced variability of VT as compared to spontaneous breathing in healthy
subjects. A reduced level of variability of VT seems to be associated with
delayed weaning from mechanical ventilation. Variable PSV is able to increase
the variability of the respiratory pattern independent from the patient*s
efforts, and has shown beneficial effects in terms of gas exchange, lung
mechanics and diffuse alveolar damage and inflammation in animal models of
acute lung injury. Furthermore, variable PSV decreased the work of breathing
and improved comfort compared to conventional PSV in some patients evaluated so
far.
Since variable PSV can reduce the mean pressure support, it may lead to a
faster reduction of pressure support and, therefore, a shorter weaning period
than conventional PSV.
Study objective
The hypothesis of this study is that variable pressure support ventilation
reduces the duration of mechanical ventilation to non-variable (convention-al)
pressure support ventilation.
Study design
International Multicenter Randomized Controlled Open Trial
Intervention
Variable PSV
Study burden and risks
Variable PSV is already commercially available in a mechanical ventilator and
approved for clinical use. Thus, physicians are allowed to use variable PSV at
their own discretion and several patients have been already ventilated with
this new mode.
Compared to conventional PSV, variable PSV has been shown to improve gas
exchange, respira-tory mechanics and breathing comfort, as well as to reduce
inflammatory infiltrates and alveolar edema in experimental acute lung injury
[11*14].
Preliminary results of the EVA Trial (Evaluation of Variable Pressure Support
Ventilation in the Therapy of Acute Lung Injury; ClinicalTrials.gov Identifier:
NCT00786292) showed that variable compared to conventional PSV did not increase
discomfort or deteriorate the cardiopulmonary function in mechanically
ventilated patients in the ICU. In fact, variable PSV importantly reduced the
work of breathing and increased comfort in some patients.
Therefore, the burden and risks to patients resulting from the intervention are
low. In fact, we hy-pothesize that patients assigned to variable PSV will be
weaned faster from the mechanical venti-lator than those assigned to
conventional PSV. Also, we expect that a considerable number of pa-tients under
variable PSV will benefit in terms of reduced work of breathing and improved
respira-tory comfort compared to non-variable (conventional) PSV.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
* Age * 18 years
* Duration of controlled mechanical ventilation * 24h
* Availability of a Infinity V500 ventilator (ready to use)
* Informed consent according to local regulations
* Temperature * 39 °C
* Hemoglobin * 6 g/dl
* PaO2/FIO2 * 150 mmHg with positive end-expiratory pressure (PEEP) *16 cmH2O
* Ability to breath spontaneously
Exclusion criteria
* Participation in another interventional trial within the last four weeks before enrollment in this trial
* Peripheral neurological disease associated with impairment of the res-piratory pump
* Muscular disease associated with impairment of the respiratory pump
* Instable thorax with paradoxical chest wall movement
* Planned surgery under general anesthesia within 72 hours
* Difficult airway/intubation
* Existing tracheotomy at ICU admission
* Expected survival < 72 hours
* Home mechanical ventilation or on chronic oxygen therapy
* Suspected pregnancy
Design
Recruitment
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 |
|---|---|
| ClinicalTrials.gov | NCT01769053 |
| CCMO | NL44074.018.13 |