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

NCT00804011 | Completed

• 1 other identifier: MS/486/Res/507
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Snake Bite; Weaning; Mechanical Ventilation

Keywords

Snakebite; Weaning; Mechanical ventilation

Outcome Measures

Primary Outcomes (1)

• Duration of weaning

  6 month

Secondary Outcomes (1)

• ICU stay

  6 month

Study Arms (2)

1

EXPERIMENTAL

Automatic tube compensation plus pressure support

Other: ATC

2

ACTIVE COMPARATOR

Pressure support alone

Other: PSV

Interventions

ATC OTHER

Automatic tube compensation

Also known as: Automatic tube compensation

1

PSV OTHER

Pressure support ventilation

Also known as: Pressure support ventilation

2

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Post Graduate Institute of Medical Education and Research, Chandigarh: lead
• Dept of Pulmonary Medicine, PGIMER, Chandigarh: collaborator

Study Sites (1)

Department of Pulmonary Medicine

Chandigarh, Uttarakhand, 160012, India

Location

MeSH Terms

Conditions

Snake Bites

Condition Hierarchy (Ancestors)

Bites and Stings; Poisoning; Chemically-Induced Disorders; Wounds and Injuries

Study Officials

• Ritesh Agarwal, MD, DM, FCCP

  PGIMER, INDIA

  PRINCIPAL INVESTIGATOR

• Ashutosh N Aggarwal, MD, DM, FCCP

  PGIMER, INDIA

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 5, 2008
• First Posted: December 8, 2008
• Study Start: July 1, 2004
• Primary Completion: December 1, 2007
• Study Completion: April 1, 2008
• Last Updated: December 8, 2008

Record last verified: 2008-12

Locations

IN (1)