Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02877498 |
| Other study ID # |
NK/2194/Study/1241(168) |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
December 2016 |
| Est. completion date |
January 31, 2020 |
Study information
| Verified date |
April 2022 |
| Source |
Postgraduate Institute of Medical Education and Research |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Neuroparalytic snake envenomation results in severe muscle weakness and respiratory failure.
Treatment requires administration of anti-snake venom and supportive care in the form of
invasive mechanical ventilation. Whether using adaptive support ventilation (a closed loop
mode of ventilation) in comparison to volume controlled ventilation will shorten the duration
of ventilation remains undetermined. The current study is planned to compare adaptive support
ventilation (ASV) mode of ventilation versus volume controlled ventilation (VCV) during
invasive mechanical ventilation for the management of respiratory failure secondary to
neuroparalytic snake envenomation.
Description:
Snake envenoming is a common medical emergency encountered in the tropical countries, and an
estimated 35,000 -50,000 people die of snakebite every year in India. The bites of elapid
snakes cause predominantly neurotoxicity, which manifests as ocular and bulbar paralysis, and
paralysis of the muscles of respiration, with resultant respiratory failure. The management
of these patients includes ventilatory support and administration of snake anti-venom.
Respiratory failure requiring mechanical ventilatory support is a frequent cause of admission
to the intensive care unit (ICU). Mechanical ventilation is a life-saving intervention, and
once there is improvement of the underlying indication, it can be withdrawn abruptly in the
majority. However, approximately 20-30% of patients still require gradual discontinuation
(ie, weaning). This process is not only difficult in patients with chronic respiratory
diseases and acute neuromuscular disorders, such as neurotoxic snake bite, but is also
associated with important complications, such as nosocomial pneumonia, prolonged ICU stay,
and even mortality, especially in those with persistent weaning failure.
Adaptive support ventilation (ASV) is a closed-loop ventilation mode designed to provide a
user-set minimum minute ventilation in intubated patients, either actively breathing or
passively ventilated. ASV automatically selects a target ventilatory pattern based on user
inputs [patient's predicted body weight (PBW), minimum minute volume, and pressure limit] and
respiratory mechanics data from the ventilator monitoring system (respiratory system
expiratory time constant and dynamic compliance). The algorithm selects ventilatory
parameters so as to minimize total work of inspiration, and the ventilator continuously
adapts to match changes in respiratory mechanics by using automatic controls for level of
inspiratory pressure above positive end-expiratory pressure (PEEP), frequency, and
inspiratory time of ventilator-initiated breaths.
In most studies, ASV has been used only in the weaning phase, and patients were ventilated
with conventional modes until weaning. However recent studies suggest its role in primary
ventilation in the initial phase of respiratory failure. Previous use of ASV in patients with
acute respiratory distress syndrome has been described from our center and the use of ASV was
equally efficacious to conventional mode of ventilation (volume control). In another study
the use of ASV in comparison to pressure control ventilation in patients with acute
respiratory failure reduced the weaning duration and total duration of mechanical
ventilation. Because ASV can be used from intubation to extubation, it may also offer some
advantages before the weaning phase in patients with respiratory failure. Therefore, we
hypothesize that ASV may shorten the total mechanical ventilation (MV) duration, weaning
duration, and increase the weaning success rates when compared with conventional ventilation
in the management of patients with neuroparalytic snake envenomation.
