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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)

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ClinicalTrials.gov Identifier: NCT02877498
Recruitment Status : Recruiting
First Posted : August 24, 2016
Last Update Posted : September 1, 2017
Sponsor:
Information provided by (Responsible Party):
Inderpaul singh, Postgraduate Institute of Medical Education and Research

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.

Condition or disease Intervention/treatment Phase
Snake Envenomation Invasive Mechanical Ventilation Adaptive Support Ventilation Other: Adaptive support ventilation Other: Volume controlled ventilation Not Applicable

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ventilation is a life-saving intervention, and once there is improvement of the underlying indication, it can be withdrawn abruptly in the majority.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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : August 2016
Estimated Primary Completion Date : August 31, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Adaptive support ventilation
adaptive support ventilation mode during invasive mechanical ventilation
Other: Adaptive support ventilation
Adaptive support ventilation during invasive mechanical ventilation

Active Comparator: Volume controlled ventilation
Volume controlled ventilation during invasive mechanical ventilation
Other: Volume controlled ventilation
Volume controlled ventilation during invasive mechanical ventilation




Primary Outcome Measures :
  1. Liberation from mechanical ventilation [ Time Frame: 28 days after discharge ]
    Liberation from mechanical ventilation (defined as time [in hours] between intubation to extubation for at least six hours)


Secondary Outcome Measures :
  1. Incidence of ventilator associated pneumonia [ Time Frame: 28 days after discharge ]
    Ventilator associated pneumonia

  2. Post extubation respiratory failure [ Time Frame: 28 days after discharge ]
    Post extubation respiratory failure (defined as need for either NIV or reintubation)

  3. In hospital mortality [ Time Frame: 28 days after discharge ]
    Death during hospital stay

  4. ICU and hospital length of stay [ Time Frame: 28 days after discharge ]
    Intensive care unit and hospital length of stay



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Ages Eligible for Study:   12 Years to 90 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02877498


Contacts
Contact: Inderpaul S Sehgal, MD,DM 9111722756823 inderpgi@outlook.com

Locations
India
Respiratory ICU, Post Graduate Institue of Medical Education and Research Recruiting
Chandigarh, India, 160012
Contact: Inderpaul S Sehgal, MD,DM    9111722756823    inderpgi@outlook.com   
Contact: Ritesh Agarwal, MD,DM    9111722756825    agarwal.ritesh@outlook.in   
Sponsors and Collaborators
Postgraduate Institute of Medical Education and Research
Investigators
Study Director: Ritesh Agarwal, MD,DM PGIMER,Chandigarh

Responsible Party: Inderpaul singh, Assistant Professor, Department of Pulmonary Medicine, Postgraduate Institute of Medical Education and Research
ClinicalTrials.gov Identifier: NCT02877498     History of Changes
Other Study ID Numbers: NK/2194/Study/1241(168)
First Posted: August 24, 2016    Key Record Dates
Last Update Posted: September 1, 2017
Last Verified: August 2017

Additional relevant MeSH terms:
Respiratory Insufficiency
Poisoning
Snake Bites
Respiration Disorders
Respiratory Tract Diseases
Chemically-Induced Disorders
Bites and Stings
Wounds and Injuries