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

Primary Purpose

Snake Envenomation, Invasive Mechanical Ventilation, Adaptive Support Ventilation

Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Adaptive support ventilation
Volume controlled ventilation
Sponsored by
Postgraduate Institute of Medical Education and Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Snake Envenomation

Eligibility Criteria

12 Years - 90 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Need for invasive mechanical ventilation for management of respiratory failure
  2. age group of 12 to 90 years
  3. ability to provide informed consent to participate in the study

Exclusion Criteria:

  1. Cardiorespiratory arrest requiring cardiopulmonary resuscitation
  2. pregnancy
  3. failure to provide informed consent

Sites / Locations

  • Respiratory ICU, Post Graduate Institue of Medical Education and Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Adaptive support ventilation

Volume controlled ventilation

Arm Description

adaptive support ventilation mode during invasive mechanical ventilation

Volume controlled ventilation during invasive mechanical ventilation

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Incidence of ventilator associated pneumonia
Ventilator associated pneumonia
Post extubation respiratory failure
Post extubation respiratory failure (defined as need for either NIV or reintubation)
In hospital mortality
Death during hospital stay
ICU and hospital length of stay
Intensive care unit and hospital length of stay

Full Information

First Posted
August 17, 2016
Last Updated
April 19, 2022
Sponsor
Postgraduate Institute of Medical Education and Research
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1. Study Identification

Unique Protocol Identification Number
NCT02877498
Brief Title
A Study to Compare Adaptive Support Ventilation vs. Volume Controlled Ventilation for Management of Respiratory Failure in Patients With Neuroparalytic Snake Envenomation
Acronym
ASV vs VCV in
Official Title
A Study to Compare Adaptive Support Ventilation vs. Volume Controlled Ventilation for Management of Respiratory Failure in Patients With Neuroparalytic Snake Envenomation
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
December 2016 (Actual)
Primary Completion Date
January 31, 2020 (Actual)
Study Completion Date
January 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Postgraduate Institute of Medical Education and Research

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Snake envenoming is a common medical emergency encountered in the tropical countries, and an estimated 35,000 -50,000 people die of snakebite every year in India. The bites of elapid snakes cause predominantly neurotoxicity, which manifests as ocular and bulbar paralysis, and paralysis of the muscles of respiration, with resultant respiratory failure. The management of these patients includes ventilatory support and administration of snake anti-venom. Respiratory failure requiring mechanical ventilatory support is a frequent cause of admission to the intensive care unit (ICU). Mechanical ventilation is a life-saving intervention, and once there is improvement of the underlying indication, it can be withdrawn abruptly in the majority. However, approximately 20-30% of patients still require gradual discontinuation (ie, weaning). This process is not only difficult in patients with chronic respiratory diseases and acute neuromuscular disorders, such as neurotoxic snake bite, but is also associated with important complications, such as nosocomial pneumonia, prolonged ICU stay, and even mortality, especially in those with persistent weaning failure. Adaptive support ventilation (ASV) is a closed-loop ventilation mode designed to provide a user-set minimum minute ventilation in intubated patients, either actively breathing or passively ventilated. ASV automatically selects a target ventilatory pattern based on user inputs [patient's predicted body weight (PBW), minimum minute volume, and pressure limit] and respiratory mechanics data from the ventilator monitoring system (respiratory system expiratory time constant and dynamic compliance). The algorithm selects ventilatory parameters so as to minimize total work of inspiration, and the ventilator continuously adapts to match changes in respiratory mechanics by using automatic controls for level of inspiratory pressure above positive end-expiratory pressure (PEEP), frequency, and inspiratory time of ventilator-initiated breaths. In most studies, ASV has been used only in the weaning phase, and patients were ventilated with conventional modes until weaning. However recent studies suggest its role in primary ventilation in the initial phase of respiratory failure. Previous use of ASV in patients with acute respiratory distress syndrome has been described from our center and the use of ASV was equally efficacious to conventional mode of ventilation (volume control). In another study the use of ASV in comparison to pressure control ventilation in patients with acute respiratory failure reduced the weaning duration and total duration of mechanical ventilation. Because ASV can be used from intubation to extubation, it may also offer some advantages before the weaning phase in patients with respiratory failure. Therefore, we hypothesize that ASV may shorten the total mechanical ventilation (MV) duration, weaning duration, and increase the weaning success rates when compared with conventional ventilation in the management of patients with neuroparalytic snake envenomation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Snake Envenomation, Invasive Mechanical Ventilation, Adaptive Support Ventilation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Adaptive support ventilation
Arm Type
Experimental
Arm Description
adaptive support ventilation mode during invasive mechanical ventilation
Arm Title
Volume controlled ventilation
Arm Type
Active Comparator
Arm Description
Volume controlled ventilation during invasive mechanical ventilation
Intervention Type
Other
Intervention Name(s)
Adaptive support ventilation
Intervention Description
Adaptive support ventilation during invasive mechanical ventilation
Intervention Type
Other
Intervention Name(s)
Volume controlled ventilation
Intervention Description
Volume controlled ventilation during invasive mechanical ventilation
Primary Outcome Measure Information:
Title
Liberation from mechanical ventilation
Description
Liberation from mechanical ventilation (defined as time [in hours] between intubation to extubation for at least six hours)
Time Frame
28 days after discharge
Secondary Outcome Measure Information:
Title
Incidence of ventilator associated pneumonia
Description
Ventilator associated pneumonia
Time Frame
28 days after discharge
Title
Post extubation respiratory failure
Description
Post extubation respiratory failure (defined as need for either NIV or reintubation)
Time Frame
28 days after discharge
Title
In hospital mortality
Description
Death during hospital stay
Time Frame
28 days after discharge
Title
ICU and hospital length of stay
Description
Intensive care unit and hospital length of stay
Time Frame
28 days after discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Cardiorespiratory arrest requiring cardiopulmonary resuscitation pregnancy failure to provide informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ritesh Agarwal, MD,DM
Organizational Affiliation
PGIMER,Chandigarh
Official's Role
Study Director
Facility Information:
Facility Name
Respiratory ICU, Post Graduate Institue of Medical Education and Research
City
Chandigarh
ZIP/Postal Code
160012
Country
India

12. IPD Sharing Statement

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

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