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Snake EnvenomationASV vs VCV inNCT02877498

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

A study testing Adaptive support ventilation in people with Snake Envenomation and Invasive Mechanical Ventilation, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 12 to 90 years
What is being tested?
Adaptive support ventilation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteIndia
Study dates
Dec 2016to 31 Jan 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 90 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

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

Who cannot join

  • Cardiorespiratory arrest requiring cardiopulmonary resuscitation
  • pregnancy
  • failure to provide informed consent

Trial locations and contacts

1 site in 1 country.

India1 site
  • Respiratory ICU, Post Graduate Institue of Medical Education and Research

    Chandigarh, 160012

Other trials in India

About this study

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.

Being tested
Adaptive support ventilation, Volume controlled ventilation
Medical subject headings
Snake Bites

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Adaptive support ventilationOther

    Adaptive support ventilation during invasive mechanical ventilation

  • Volume controlled ventilationOther

    Volume controlled ventilation during invasive mechanical ventilation

Study groups in NCT02877498
Study groupRoleWhat they receive
Adaptive support ventilationExperimentaladaptive support ventilation mode during invasive mechanical ventilation
Receives: Other: Adaptive support ventilation
Volume controlled ventilationActive comparatorVolume controlled ventilation during invasive mechanical ventilation
Receives: Other: Volume controlled ventilation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Liberation from mechanical ventilation

    Liberation from mechanical ventilation (defined as time [in hours] between intubation to extubation for at least six hours)

    Measured: 28 days after discharge

Secondary outcomes (4)
  1. Incidence of ventilator associated pneumonia

    Ventilator associated pneumonia

    Measured: 28 days after discharge

  2. Post extubation respiratory failure

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

    Measured: 28 days after discharge

  3. In hospital mortality

    Death during hospital stay

    Measured: 28 days after discharge

  4. ICU and hospital length of stay

    Intensive care unit and hospital length of stay

    Measured: 28 days after discharge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Aug 2016 (estimated)
  2. Study startDec 2016
  3. Primary completion31 Jan 2020
  4. Study completion31 Jan 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02877498
Sponsor's protocol ID
NK/2194/Study/1241(168)
Acronym
ASV vs VCV in
Status last verified
Apr 2022
First submitted
17 Aug 2016
Last updated
20 Apr 2022
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Adaptive support ventilation in people with Snake Envenomation and Invasive Mechanical Ventilation, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Liberation from mechanical ventilation (time frame: 28 days after discharge). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2022.

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