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Automatic Tube Compensation (ATC) for Weaning Patients With Severe Neurotoxic Snake Envenoming
This study has been completed.
First Received: December 5, 2008   No Changes Posted
Sponsors and Collaborators: Postgraduate Institute of Medical Education and Research
Dept of Pulmonary Medicine, PGIMER, Chandigarh
Information provided by: Postgraduate Institute of Medical Education and Research
ClinicalTrials.gov Identifier: NCT00804011
  Purpose

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.


Condition Intervention
Snake Bite
Weaning
Mechanical Ventilation
Other: ATC
Other: PSV

MedlinePlus related topics: Animal Bites
U.S. FDA Resources
Study Type: Interventional
Study Design: Supportive Care, Randomized, Open Label, Active Control, Parallel Assignment
Official Title: Automatic Tube Compensation Versus Pressure Support in Weaning Patients With Severe Neurotoxic Snake Envenoming

Further study details as provided by Postgraduate Institute of Medical Education and Research:

Primary Outcome Measures:
  • Duration of weaning [ Time Frame: 6 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • ICU stay [ Time Frame: 6 month ] [ Designated as safety issue: No ]

Enrollment: 41
Study Start Date: July 2004
Study Completion Date: April 2008
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Automatic tube compensation plus pressure support
Other: ATC
Automatic tube compensation
2: Active Comparator
Pressure support alone
Other: PSV
Pressure support ventilation

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  • 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.

Exclusion Criteria:

  • If they do not meet the inclusion criteria
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00804011

Locations
India, UT
Department of Pulmonary Medicine
Chandigarh, UT, India, 160012
Sponsors and Collaborators
Postgraduate Institute of Medical Education and Research
Dept of Pulmonary Medicine, PGIMER, Chandigarh
Investigators
Principal Investigator: Ritesh Agarwal, MD, DM, FCCP PGIMER, INDIA
Study Chair: Ashutosh N Aggarwal, MD, DM, FCCP PGIMER, INDIA
  More Information

No publications provided

Responsible Party: PGIMER, India ( Dr Ritesh Agarwal )
Study ID Numbers: MS/486/Res/507
Study First Received: December 5, 2008
Last Updated: December 5, 2008
ClinicalTrials.gov Identifier: NCT00804011     History of Changes
Health Authority: India: IEC, PGIMER, Chandigarh

Keywords provided by Postgraduate Institute of Medical Education and Research:
Snakebite
Weaning
Mechanical ventilation

Study placed in the following topic categories:
Poisoning
Disorders of Environmental Origin
Bites and Stings
Snake Bites

Additional relevant MeSH terms:
Poisoning
Disorders of Environmental Origin
Bites and Stings
Snake Bites

ClinicalTrials.gov processed this record on May 07, 2009