Acute Respiratory Failure, Critical Illness, Ventilation Weaning
Conditions
Keywords
Acute respiratory failure, Critical illness, Mechanical ventilation, Ventilation weaning, Intensive Care Unit, Variable (NOISY) PSV, PSV
Brief summary
Variable PSV is a new ventilatory mode which delivered a pressure support variable from 0 to 100% variation of the set PSV level.This study aimed to compare the ventilatory behavior, sleep quality and gas exchange between VARIABLE (or Noisy)-PSV and standard (or fixed)-PSV during the weaning phase of critically ill patients who required mechanical ventilation.
Detailed description
Twenty patients will be enrolled. They will be ventilated withVARIABLE-PSV and STANDARD-PSV: for 24 h each in a randomized crossover order. The ventilatory parameters, ventilator/patient asynchrony, gas exchange effects, sleep quality and ventilatory comfort produced by the two ventilation modes will be compared. Before randomisation, a sequence of VARIABLE-PSV will be performed with different level of variation setting to better define the future behavior of the patient under this mode during the 24 h of Variable-PSV.
Interventions
OTHERVARIABLE-PSV ventilatory mode
The two ventilatory modes will be studied during 24h in intubated patients in random order.
OTHERSTANDARD-PSV ventilatory mode
The two ventilatory modes will be studied during 24h in intubated patients in random order.
Sponsors
University Hospital, Montpellier
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* ventilation planned for more than 48 h * patient alert and calm corresponding to a Richmond Agitation-Sedation Scale (RASS) between -2 and 0 * Age \> or equal 18 * Surrogate decision maker's consent
Exclusion criteria
* Clinical instability for any reason. * Life support withdrawal code * Patient under tutelage * Pregnancy * No French health insurance
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oxygenation in each ventilatory mode | after 24h of mechanical ventilation in each mode | We will performed arterial blood gases and oxygenation wil be evaluated by the PaO2/FiO2 ration. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ventilatory comfort | during 24h in each mode | Comfort zone is defined as previously reported in some papers as considered adequate ventilation : 6 \< tidal volume \< 10 ml/kg, ETCO2 \< 55 mmHg and \< 65 mmHg for COPD patients and 12 \< Respiratory rate \< 35 cycles/min. |
| Feasibility | during the 24 hours | Evaluation of time spent in each mode during the 24 hours of ventilation without any side effects and switch for another ventilatory mode. |
| Patient/ventilator asynchronism | during the 24 hours | Evaluation of number of asynchrony evaluated by an Asynchrony Index (AI) in each mode during the 24 hours of mechanical ventilation |
| Ventilatory effects | during the 24 hours | Evaluation of machine ventilatory behaviors in each mode during the 24 hours of mechanical ventilation. |
| Sleep quality | after the 24 hours | Evaluation of quality of sleep in each mode after the 24h of mechanical ventilation |
Countries
France
Outcome results
None listed