A Study to Compare Adaptive Support Ventilation vs. Volume Controlled Ventilation for Management of Respiratory Failure in Patients With Neuroparalytic Snake Envenomation (ASV vs VCV in)

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.

Study Overview

• Status: Completed
• Conditions: Invasive Mechanical Ventilation; Snake Envenomation; Adaptive Support Ventilation
• Intervention / Treatment: Other: Adaptive support ventilation; Other: Volume controlled ventilation

Detailed 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ventilation is a life-saving intervention, and once there is improvement of the underlying indication, it can be withdrawn abruptly in the majority.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.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Chandigarh, India, 160012
    • Respiratory ICU, Post Graduate Institue of Medical Education and Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 90 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Need for invasive mechanical ventilation for management of respiratory failure
2. age group of 12 to 90 years
3. ability to provide informed consent to participate in the study

Exclusion Criteria:

1. Cardiorespiratory arrest requiring cardiopulmonary resuscitation
2. pregnancy
3. failure to provide informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Adaptive support ventilation; adaptive support ventilation mode during invasive mechanical ventilation	Other: Adaptive support ventilation; Adaptive support ventilation during invasive mechanical ventilation
ACTIVE_COMPARATOR: Volume controlled ventilation; Volume controlled ventilation during invasive mechanical ventilation	Other: Volume controlled ventilation; Volume controlled ventilation during invasive mechanical ventilation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Liberation from mechanical ventilation	Liberation from mechanical ventilation (defined as time [in hours] between intubation to extubation for at least six hours)	28 days after discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of ventilator associated pneumonia	Ventilator associated pneumonia	28 days after discharge
Post extubation respiratory failure	Post extubation respiratory failure (defined as need for either NIV or reintubation)	28 days after discharge
In hospital mortality	Death during hospital stay	28 days after discharge
ICU and hospital length of stay	Intensive care unit and hospital length of stay	28 days after discharge

Collaborators and Investigators

• Sponsor: Postgraduate Institute of Medical Education and Research
• Investigators: Study Director: Ritesh Agarwal, MD,DM, PGIMER,Chandigarh

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 1, 2016
• Primary Completion (ACTUAL): January 31, 2020
• Study Completion (ACTUAL): January 31, 2020

Study Registration Dates

• First Submitted: August 17, 2016
• First Submitted That Met QC Criteria: August 19, 2016
• First Posted (ESTIMATE): August 24, 2016

Study Record Updates

• Last Update Posted (ACTUAL): April 20, 2022
• Last Update Submitted That Met QC Criteria: April 19, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Respiratory Tract Diseases; Respiration Disorders; Wounds and Injuries; Bites and Stings; Poisoning; Respiratory Insufficiency; Snake Bites
• Other Study ID Numbers: NK/2194/Study/1241(168)