A Study to Compare Adaptive Support Ventilation vs. Volume Controlled Ventilation for Management of Respiratory Failure in Patients With Neuroparalytic Snake Envenomation

NCT02877498 | Completed DMC

• 1 other identifier: NK/2194/Study/1241(168)
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Snake Envenomation; Invasive Mechanical Ventilation; Adaptive Support Ventilation

Outcome Measures

Primary Outcomes (1)

• Liberation from mechanical ventilation

  Liberation from mechanical ventilation (defined as time \[in hours\] between intubation to extubation for at least six hours)

  28 days after discharge

Secondary Outcomes (4)

• Incidence of ventilator associated pneumonia

  28 days after discharge

• Post extubation respiratory failure

  28 days after discharge

• In hospital mortality

  28 days after discharge

• ICU and hospital length of stay

  28 days after discharge

Study Arms (2)

Adaptive support ventilation

EXPERIMENTAL

adaptive support ventilation mode during invasive mechanical ventilation

Other: Adaptive support ventilation

Volume controlled ventilation

ACTIVE COMPARATOR

Volume controlled ventilation during invasive mechanical ventilation

Other: Volume controlled ventilation

Interventions

Adaptive support ventilation OTHER

Adaptive support ventilation during invasive mechanical ventilation

Adaptive support ventilation

Volume controlled ventilation OTHER

Volume controlled ventilation during invasive mechanical ventilation

Volume controlled ventilation

Eligibility Criteria

• Age: 12 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Cardiorespiratory arrest requiring cardiopulmonary resuscitation
• pregnancy
• failure to provide informed consent

Sponsors & Collaborators

• Post Graduate Institute of Medical Education and Research, Chandigarh: lead

Study Sites (1)

Respiratory ICU, Post Graduate Institue of Medical Education and Research

Chandigarh, 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

  PGIMER,Chandigarh

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Pulmonary Medicine

Study Record Dates

• First Submitted: August 17, 2016
• First Posted: August 24, 2016
• Study Start: December 1, 2016
• Primary Completion: January 31, 2020
• Study Completion: January 31, 2020
• Last Updated: April 20, 2022

Record last verified: 2022-04

Locations

IN (1)