Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Evaluation of the Versamed iVent in the Transport of Patients Receiving Mechanical Ventilation

This study has been terminated.
Sponsor:
Information provided by:
Tufts Medical Center
ClinicalTrials.gov Identifier:
NCT00652756
First received: April 1, 2008
Last updated: July 19, 2011
Last verified: July 2011

April 1, 2008
July 19, 2011
August 2007
February 2012   (final data collection date for primary outcome measure)
To determine whether using a ventilator during patient transport has better outcomes than the current approach to transport. [ Time Frame: One year (estimated) ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00652756 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Evaluation of the Versamed iVent in the Transport of Patients Receiving Mechanical Ventilation
Evaluation of the Versamed iVent in the Transport of Patients Receiving Mechanical Ventilation

The purpose of this study is to evaluate the use of the VersaMed iVent ventilator in the acute care setting, hypothesizing that, in comparison to the standard approach, the use of the VersaMed will facilitate transport and reduce transport-associated complications while providing equivalent ventilatory support and transport success rates for both intubated patients and patients receiving noninvasive ventilation.

Transporting acute-care patients who require mechanical ventilation within a hospital can be fraught with hazards. Prior studies have revealed a high level of transport-associated complications including episodes of hypertension, hypoxemia, respiratory arrest, and death (1). In many institutions, the preferred method of transporting intubated patients is to use manual ventilation with a resuscitator bag, an approach that fully occupies one member of the transport team. Using a transport ventilator involves taking an intubated patient who has been placed on one ventilator and switching the patient to the transport ventilator; until now, transport ventilators had not been designed to match the capabilities of the more robustly engineered critical care ventilators.

The use of noninvasive ventilation (NIV) to treat patients with COPD exacerbations and other forms of respiratory failure has increased because of its demonstrated efficacy in reducing the need for intubation as well as morbidity and mortality (2). None of the ventilators usually used for noninvasive ventilation was designed for in-patient transport.

Currently, the standard of care in this institution is to transport intubated patients receiving mechanical ventilation by using a manual resuscitation bag and to transport patients receiving NIV by placing the patient on oxygen therapy without ventilatory support.

The VersaMed iVent ventilator was designed to treat respiratory failure in the acute care setting. The device is suitable for patients who are intubated as well as for patients receiving noninvasive ventilation, has a backup battery so that it can function during transport, and has been approved by the FDA for invasive and noninvasive mechanical ventilation. This device permits continuity of mechanical ventilation virtually regardless of patient status.

We propose to evaluate the utility of the VersaMed iVent ventilator in the acute care setting, hypothesizing that, in comparison to the standard approach, the use of the VersaMed will facilitate transport, reduce transport-associated complications, and provide equivalent ventilatory support and transport-success rates for both intubated patients and patients receiving NIV.

References

  1. Braman SS, Dunn SM, Amico CA, Millman RP. Complications of intrahospital transport in critically ill patients. Ann Intern Med 1987; 107:469-73.
  2. Mehta S, Hill NS. Noninvasive ventilation-state of the art. Am J Respir Crit Care Med 2001; Feb; 163(2):540-77.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Respiration, Artificial
  • Device: Use of ventilator during patient transport (Versamed iVent)
    The goal of the transport ventilator is to provide optimal ventilation.
    Other Name: Versamed iVent ventilator
  • Other: Bag-valve ventilation
    Use of bag-valve ventilation during patient transport.
    Other Name: Use of manual resuscitator during transport.
  • Experimental: 1
    Patient is placed on a transport ventilator.
    Intervention: Device: Use of ventilator during patient transport (Versamed iVent)
  • 2
    Patient is ventilated using the current standard at this institution.
    Intervention: Other: Bag-valve ventilation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
50
February 2012
February 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients eligible for the trial will be receiving mechanical ventilation in the emergency department, critical care, and other patient care areas; and will require transport within the hospital.

Exclusion Criteria:

  • Patient must be at least eighteen years of age.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00652756
7299, 000
No
Nicholas S. Hill, MD, Tufts Medical Center
Tufts Medical Center
Not Provided
Principal Investigator: Nicholas S. Hill, MD Tufts Medical Center
Tufts Medical Center
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP