An interventional study of Adaptive support ventilation and Volume controlled ventilation in Snake Envenomation, Invasive Mechanical Ventilation and Adaptive Support Ventilation, sponsored by Post Graduate Institute of Medical Education and Research, Chandigarh. Completed at 1 site in India. Open to participants aged 12 Years to 90 Years. Per ClinicalTrials.gov, last updated 2022-04-20.
Sponsored by Post Graduate Institute of Medical Education and Research, Chandigarh · Not applicable, Interventional, and Treatment
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.
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ventilation is a life-saving intervention, and once there is improvement of the underlying indication, it can be withdrawn abruptly in the majority.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.
38 studies on the registry are indexed under Snake Bites; 11 are open to participants now.
This study's planned enrollment of 50 is below the median of 70 across 18 interventional studies indexed under Snake Bites.
Browse Snake Bites studies →Post Graduate Institute of Medical Education and Research, Chandigarh is the lead sponsor of 298 studies on the registry; 45 are open to participants now.
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Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
adaptive support ventilation mode during invasive mechanical ventilation
Other: Adaptive support ventilation
Volume controlled ventilation during invasive mechanical ventilation
Other: Volume controlled ventilation
Adaptive support ventilation during invasive mechanical ventilation
Volume controlled ventilation during invasive mechanical ventilation
Liberation from mechanical ventilation
Liberation from mechanical ventilation (defined as time \[in hours\] between intubation to extubation for at least six hours)
Time frame: 28 days after discharge
Incidence of ventilator associated pneumonia
Ventilator associated pneumonia
Time frame: 28 days after discharge
Post extubation respiratory failure
Post extubation respiratory failure (defined as need for either NIV or reintubation)
Time frame: 28 days after discharge
In hospital mortality
Death during hospital stay
Time frame: 28 days after discharge
ICU and hospital length of stay
Intensive care unit and hospital length of stay
Time frame: 28 days after discharge
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