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CompletedNCT02877498ASV vs VCV inUpdated Apr 20, 2022

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

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

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
12 Years to 90 Years
Sex
All
01

Study 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.

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ventilation is a life-saving intervention, and once there is improvement of the underlying indication, it can be withdrawn abruptly in the majority.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

02

Conditions studied

  • Snake Envenomation
  • Invasive Mechanical Ventilation
  • Adaptive Support Ventilation

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03

In context

Snake Bites

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.

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Lead sponsor

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.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 to participate in the study

Exclusion criteria

Exclusion Criteria:

  1. Cardiorespiratory arrest requiring cardiopulmonary resuscitation
  2. pregnancy
  3. failure to provide
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

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05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    Adaptive support ventilation

    adaptive support ventilation mode during invasive mechanical ventilation

    Other: Adaptive support ventilation

  • Active comparator
    Volume controlled ventilation

    Volume controlled ventilation during invasive mechanical ventilation

    Other: Volume controlled ventilation

Interventions

  • OtherAdaptive support ventilation

    Adaptive support ventilation during invasive mechanical ventilation

  • OtherVolume controlled ventilation

    Volume controlled ventilation during invasive mechanical ventilation

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. Incidence of ventilator associated pneumonia

    Ventilator associated pneumonia

    Time frame: 28 days after discharge

  2. Post extubation respiratory failure

    Post extubation respiratory failure (defined as need for either NIV or reintubation)

    Time frame: 28 days after discharge

  3. In hospital mortality

    Death during hospital stay

    Time frame: 28 days after discharge

  4. ICU and hospital length of stay

    Intensive care unit and hospital length of stay

    Time frame: 28 days after discharge

07

Study locations

1 site
  • Respiratory ICU, Post Graduate Institue of Medical Education and Research
    Chandigarh, 160012, India
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 20, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02877498
Responsible party
Inderpaul singh (Assistant Professor, Department of Pulmonary Medicine, Post Graduate Institute of Medical Education and Research, Chandigarh) — Principal investigator
First posted
Aug 24, 2016
Start date
Dec 2016
Primary completion
Jan 31, 2020
Completion
Jan 31, 2020
Last update
Apr 20, 2022

Study contacts

Ritesh Agarwal, MD,DM
study director · PGIMER,Chandigarh

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.

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