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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
  Purpose

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.


Condition Intervention
Respiration, Artificial
Device: Use of ventilator during patient transport (Versamed iVent)
Other: Bag-valve ventilation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of the Versamed iVent in the Transport of Patients Receiving Mechanical Ventilation

Further study details as provided by Tufts Medical Center:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 50
Study Start Date: August 2007
Estimated Study Completion Date: February 2012
Estimated Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Patient is placed on a transport ventilator.
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
2
Patient is ventilated using the current standard at this institution.
Other: Bag-valve ventilation
Use of bag-valve ventilation during patient transport.
Other Name: Use of manual resuscitator during transport.

Detailed Description:

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00652756

Locations
United States, Massachusetts
Tufts Medical Center
Boston, Massachusetts, United States, 01770
Sponsors and Collaborators
Tufts Medical Center
Investigators
Principal Investigator: Nicholas S. Hill, MD Tufts Medical Center
  More Information

No publications provided

Responsible Party: Nicholas S. Hill, MD, Tufts Medical Center
ClinicalTrials.gov Identifier: NCT00652756     History of Changes
Other Study ID Numbers: 7299, 000
Study First Received: April 1, 2008
Last Updated: July 19, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Tufts Medical Center:
Respiration, Artificial
Transportation of Patients
Intubation, Intratracheal
Tracheostomy

ClinicalTrials.gov processed this record on November 20, 2014