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.
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
- Conditions the study is for
- Snake Envenomation, Invasive Mechanical Ventilation, Adaptive Support Ventilation
- 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
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 group | Role | What they receive |
|---|---|---|
| Adaptive support ventilation | Experimental | adaptive support ventilation mode during invasive mechanical ventilation Receives: Other: Adaptive support ventilation |
| Volume controlled ventilation | Active comparator | Volume 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.
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)
Incidence of ventilator associated pneumonia
Ventilator associated pneumonia
Measured: 28 days after discharge
Post extubation respiratory failure
Post extubation respiratory failure (defined as need for either NIV or reintubation)
Measured: 28 days after discharge
In hospital mortality
Death during hospital stay
Measured: 28 days after discharge
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.
- First posted24 Aug 2016 (estimated)
- Study startDec 2016
- Primary completion31 Jan 2020
- Study completion31 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Snake EnvenomationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Inderpaul singh, Post Graduate Institute of Medical Education and Research, Chandigarh
- Investigators
- Ritesh Agarwal, MD,DM, Study director, PGIMER,Chandigarh
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
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Compare Adaptive Support Ventilation vs. Volume Controlled Ventilation for Management of Respiratory Failure in Patients With Neuroparalytic Snake Envenomation
- ClinicalTrials.gov ID
- NCT02877498
- Acronym / sponsor ID
- ASV vs VCV in / NK/2194/Study/1241(168)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, ChandigarhUniversity, hospital or other
- Study start
- Dec 2016 (actual)
- Primary completion
- 31 Jan 2020 (actual)
- Study completion
- 31 Jan 2020 (actual)
- First posted
- 24 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adaptive support ventilation | Experimental | Other: Adaptive support ventilationadaptive support ventilation mode during invasive mechanical ventilation |
| Volume controlled ventilation | Active comparator | Other: Volume controlled ventilationVolume controlled ventilation during invasive mechanical ventilation |
Who may qualify
- Ages
- 12 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Cardiorespiratory arrest requiring cardiopulmonary resuscitation
- pregnancy
- failure to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adaptive support ventilationAdaptive support ventilation during invasive mechanical ventilation | Other | Adaptive support ventilation |
| Volume controlled ventilationVolume controlled ventilation during invasive mechanical ventilation | Other | Volume controlled ventilation |
Primary outcome
Liberation from mechanical ventilation
Time frame: 28 days after discharge
Liberation from mechanical ventilation (defined as time [in hours] between intubation to extubation for at least six hours)
4 secondary outcomes
Incidence of ventilator associated pneumonia
Time frame: 28 days after discharge
Post extubation respiratory failure
Time frame: 28 days after discharge
In hospital mortality
Time frame: 28 days after discharge
ICU and hospital length of stay
Time frame: 28 days after discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2022.
Related trials for Snake Envenomation
RecruitingObservational study
Mapping Snakebite Risk in Ghana and Rwanda
Snakebite, Snake Envenomation
RecruitingObservational study
Predictive Accuracy of the Snakebite Severity Score (SSS) in Identifying Syndrome-Specific Core Outcome Parameters Among Envenomated Patients Presenting to the Emergency Department
Snake Bite
Not yet recruitingObservational study
Point-of-care Ultrasound in the Assessment of Snake Bite
Rattlesnake Bite (Diagnosis)
RecruitingObservational study
Polyvalent Antivenom (Premium-PANAF) for Snakebite Envenoming in Ethiopia
Snake Envenomation
Enrolling by invitationObservational study
Multicenter Application Verification and Effect Evaluation of Artificial Intelligence-Based Snake Species Identification System in the Diagnosis and Treatment of Snakebites
Snake Bite
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ritesh Agarwal, MD,DM study director
PGIMER,Chandigarh
1 site in 1 country: see every site and its status.
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.