ClinicalTrials.gg
CompletedNCT00804011ATCUpdated Dec 8, 2008

Automatic Tube Compensation (ATC) for Weaning Patients With Severe Neurotoxic Snake Envenoming

An interventional study of ATC and PSV in Snake Bite, Weaning and Mechanical Ventilation, sponsored by Post Graduate Institute of Medical Education and Research, Chandigarh. Completed at 1 site in India. Per ClinicalTrials.gov, last updated 2008-12-08.

Sponsored by Post Graduate Institute of Medical Education and Research, Chandigarh · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
41
Allocation
Randomized
Sex
All
01

Study 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 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intervention and once there is improvement of the underlying indication for mechanical ventilation, it can be withdrawn abruptly in the majority.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.

02

Conditions studied

  • Snake Bite
  • Weaning
  • Mechanical Ventilation

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Keywords

  • Snakebite
  • Weaning
  • Mechanical ventilation
03

In context

Snake Bites

38 studies on the registry are indexed under Snake Bites; 11 are open to participants now.

This study's enrollment of 41 is below the median of 70 across 18 interventional studies indexed under Snake Bites.

Browse Snake Bites studies →

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
Child (0–17), Adult (18–64), Older adult (65+)
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

  • 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
  • more than 9 gm/dL (viii) systolic blood pressure more than 90 mm Hg
  • Overall physician assessment whether the patient is fit for weaning.

Exclusion criteria

Exclusion Criteria:

  • If they do not meet the inclusion criteria
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.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
41 participants (actual)

Study arms

  • Experimental
    1

    Automatic tube compensation plus pressure support

    Other: ATC

  • Active comparator
    2

    Pressure support alone

    Other: PSV

Interventions

  • OtherATC

    Automatic tube compensation

    Also known as: Automatic tube compensation

  • OtherPSV

    Pressure support ventilation

    Also known as: Pressure support ventilation

06

What researchers measure

Primary outcomes

  1. Duration of weaning

    Time frame: 6 month

Secondary outcomes

  1. ICU stay

    Time frame: 6 month

07

Study locations

1 site
  • Department of Pulmonary Medicine
    Chandigarh, UT 160012, India
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jul 2004, a primary completion of Dec 2007 and a completion of Apr 2008. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 5, 2008
First posted
Dec 8, 2008
Start
Jul 2004
Primary completionActual
Dec 2007
CompletionActual
Apr 2008
Last update
Dec 8, 2008
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 8, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00804011
Collaborators
Dept of Pulmonary Medicine, PGIMER, Chandigarh
First posted
Dec 8, 2008
Start date
Jul 2004
Primary completion
Dec 2007
Completion
Apr 2008
Last update
Dec 8, 2008

Study contacts

Ritesh Agarwal, MD, DM, FCCP
principal investigator · PGIMER, INDIA
Ashutosh N Aggarwal, MD, DM, FCCP
study chair · PGIMER, INDIA

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2008. You cannot join it, but the record below documents what was studied.

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