Snake BiteATCNCT00804011
Automatic Tube Compensation (ATC) for Weaning Patients With Severe Neurotoxic Snake Envenoming
A study testing ATC and PSV in people with Snake Bite and Weaning, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
Trial summary
In the mechanically ventilated patient, the single greatest cause of imposed work of breathing is the resistance caused by the endotracheal tube. Commonly used maneuvers to overcome this resistance include the use of continuous positive airway pressure or pressure support.However, a new mode of ventilatory support… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Snake Bite, Weaning, Mechanical Ventilation
- What is being tested?
- ATC and PSV
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteIndia
- Study dates
- Jul 2004to Apr 2008
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with severe neurotoxic snake envenoming (defined as requirement of mechanical ventilation for ventilatory failure) will be included in the study. - Snake envenoming will be diagnosed on the history of snakebite, presence of fang marks, presence of local manifestations such as swelling, cellulitis, blister formation; or if the dead snake is brought for identification.
- Significant improvement in the neuroparalysis with improvement in grade of power to at least MRC 3
- Normal sensorium
- Minimal suction requirements (less than thrice in the eight hours preceding the assessment
- No requirement for any vasoactive drugs
- No sedation (vi) core temperature less than 38.0°C
- Hemoglobin more than 9 gm/dL (viii) systolic blood pressure more than 90 mm Hg
- Overall physician assessment whether the patient is fit for weaning.
Who cannot join
- If they do not meet the inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Automatic Tube Compensation Versus Pressure Support in Weaning Patients With Severe Neurotoxic Snake Envenoming
In the mechanically ventilated patient, the single greatest cause of imposed work of breathing is the resistance caused by the endotracheal tube. Commonly used maneuvers to overcome this resistance include the use of continuous positive airway pressure or pressure support.However, a new mode of ventilatory support called automatic tube compensation (ATC) delivers exactly the amount of pressure necessary to overcome the resistive load imposed by the endotracheal tube for the flow measured at the time (so called variable pressure support).
The aim of this study is to evaluate whether a combination of pressure support with automatic tube compensation is superior to PS alone in weaning patients with severe neurotoxic snake envenoming.
Read the detailed description
Snake envenoming is a common medical emergency encountered in the tropical countries, and an estimated 35,000 to 50,000 people die of snake bite every year in India. The bites of Elapid snakes cause predominantly neurotoxicity, which manifests as paralysis of the muscles of the eyes, tongue, throat and respiration, leading to respiratory failure, and if untreated death. The management of these patients includes ventilatory support and administration of snake anti-venom (SAV). Respiratory failure, requiring mechanical ventilatory support, is a frequent cause for admission to the intensive care unit (ICU).
Mechanical ventilation is a life-saving intervention and once there is improvement of the underlying indication for mechanical ventilation, it can be withdrawn abruptly in the majority. However, approximately 20-30% of patients still require gradual discontinuation i.e. weaning. This process is not only difficult in patients with chronic respiratory diseases and neuromuscular disorders like neurotoxic snake bite, but is also associated with significant complications like pneumonia, prolonged ICU stay and even mortality, especially in those with persistent weaning failure.
In the mechanically ventilated patient, it has long been recognized that the single greatest cause of imposed work of breathing (WOB) is the resistance caused by the endotracheal tube (ETT). Commonly used maneuvers to overcome the ETT resistance include the use of continuous positive airway pressure (CPAP) or pressure support (PS). However, a new mode of ventilatory support called automatic tube compensation (ATC) delivers exactly the amount of pressure necessary to overcome the resistive load imposed by the endotracheal tube for the flow measured at the time (so called variable pressure support). This mode theoretically can decrease weaning duration and increase the probability of successful extubation by decreasing the WOB.
Recently, we have reported our ICU data of 55 patients of severe neurotoxic snake envenoming in which we evaluated if usage of a higher dosage of SAV offered any significant clinical advantage over a lower dose, and found no difference between the high-dose and low-dose groups. The aim of this study is to evaluate whether a combination of PS with ATC is superior to PS alone in weaning patients with severe neurotoxic snake envenoming.
- Conditions
- Snake Bite, Weaning, Mechanical Ventilation
- Being tested
- ATC, PSV
- Keywords
- Snakebite, Weaning, Mechanical 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.
ATCOther
Also called Automatic tube compensation
Automatic tube compensation
PSVOther
Also called Pressure support ventilation
Pressure support ventilation
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Automatic tube compensation plus pressure support Receives: Other: ATC |
| 2 | Active comparator | Pressure support alone Receives: Other: PSV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of weaning
Measured: 6 month
Secondary outcomes (1)
ICU stay
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2008 (estimated)
- Study startJul 2004
- Primary completionDec 2007
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Snake BiteStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Sponsor type
- University, hospital or other
- Collaborators
- Dept of Pulmonary Medicine, PGIMER, Chandigarh
- Investigators
- Ritesh Agarwal, MD, DM, FCCP, Principal investigator, PGIMER, INDIAAshutosh N Aggarwal, MD, DM, FCCP, Study chair, PGIMER, INDIA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00804011
- Sponsor's protocol ID
- MS/486/Res/507
- Acronym
- ATC
- Status last verified
- Dec 2008
- First submitted
- 5 Dec 2008
- Last updated
- 8 Dec 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Automatic Tube Compensation Versus Pressure Support in Weaning Patients With Severe Neurotoxic Snake Envenoming
- ClinicalTrials.gov ID
- NCT00804011
- Acronym / sponsor ID
- ATC / MS/486/Res/507
- Conditions
- Snake Bite, Weaning, Mechanical Ventilation
- Keywords
- Snakebite, Weaning, Mechanical ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, ChandigarhUniversity, hospital or other
- Collaborators
- Dept of Pulmonary Medicine, PGIMER, Chandigarh
- Study start
- Jul 2004
- Primary completion
- Dec 2007 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 8 Dec 2008 (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.
In the mechanically ventilated patient, the single greatest cause of imposed work of breathing is the resistance caused by the endotracheal tube. Commonly used maneuvers to overcome this resistance include the use of continuous positive airway pressure or pressure support.However, a new mode of ventilatory support called automatic tube compensation (ATC) delivers exactly the amount of pressure necessary to overcome the resistive load imposed by the endotracheal tube for the flow measured at the time (so called variable pressure support).
The aim of this study is to evaluate whether a combination of pressure support with automatic tube compensation is superior to PS alone in weaning patients with severe neurotoxic snake envenoming.
Detailed description
Snake envenoming is a common medical emergency encountered in the tropical countries, and an estimated 35,000 to 50,000 people die of snake bite every year in India. The bites of Elapid snakes cause predominantly neurotoxicity, which manifests as paralysis of the muscles of the eyes, tongue, throat and respiration, leading to respiratory failure, and if untreated death. The management of these patients includes ventilatory support and administration of snake anti-venom (SAV). Respiratory failure, requiring mechanical ventilatory support, is a frequent cause for admission to the intensive care unit (ICU).
Mechanical ventilation is a life-saving intervention and once there is improvement of the underlying indication for mechanical ventilation, it can be withdrawn abruptly in the majority. However, approximately 20-30% of patients still require gradual discontinuation i.e. weaning. This process is not only difficult in patients with chronic respiratory diseases and neuromuscular disorders like neurotoxic snake bite, but is also associated with significant complications like pneumonia, prolonged ICU stay and even mortality, especially in those with persistent weaning failure.
In the mechanically ventilated patient, it has long been recognized that the single greatest cause of imposed work of breathing (WOB) is the resistance caused by the endotracheal tube (ETT). Commonly used maneuvers to overcome the ETT resistance include the use of continuous positive airway pressure (CPAP) or pressure support (PS). However, a new mode of ventilatory support called automatic tube compensation (ATC) delivers exactly the amount of pressure necessary to overcome the resistive load imposed by the endotracheal tube for the flow measured at the time (so called variable pressure support). This mode theoretically can decrease weaning duration and increase the probability of successful extubation by decreasing the WOB.
Recently, we have reported our ICU data of 55 patients of severe neurotoxic snake envenoming in which we evaluated if usage of a higher dosage of SAV offered any significant clinical advantage over a lower dose, and found no difference between the high-dose and low-dose groups. The aim of this study is to evaluate whether a combination of PS with ATC is superior to PS alone in weaning patients with severe neurotoxic snake envenoming.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: ATCAutomatic tube compensation plus pressure support |
| 2 | Active comparator | Other: PSVPressure support alone |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Patients with severe neurotoxic snake envenoming (defined as requirement of mechanical ventilation for ventilatory failure) will be included in the study. - Snake envenoming will be diagnosed on the history of snakebite, presence of fang marks, presence of local manifestations such as swelling, cellulitis, blister formation; or if the dead snake is brought for identification.
- Significant improvement in the neuroparalysis with improvement in grade of power to at least MRC 3
- Normal sensorium
- Minimal suction requirements (less than thrice in the eight hours preceding the assessment
- No requirement for any vasoactive drugs
Key exclusion criteria (1 listed)
- If they do not meet the inclusion criteria
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 |
|---|---|---|
| ATCAlso: Automatic tube compensationAutomatic tube compensation | Other | 1 |
| PSVAlso: Pressure support ventilationPressure support ventilation | Other | 2 |
Primary outcome
Duration of weaning
Time frame: 6 month
1 secondary outcome
ICU stay
Time frame: 6 month
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 8 Dec 2008.
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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, FCCP principal investigator
PGIMER, INDIA
Ashutosh N Aggarwal, MD, DM, FCCP study chair
PGIMER, INDIA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ATC and PSV in people with Snake Bite and Weaning, 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 8 inclusion and 1 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 8 Dec 2008. 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?
Duration of weaning (time frame: 6 month). 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 8 Dec 2008.