Ignite Creation Date:
2025-12-24 @ 11:24 PM
Ignite Modification Date:
2026-01-05 @ 6:19 PM
Study NCT ID:
NCT00652756
Status:
WITHDRAWN
Last Update Posted:
2017-04-06
First Post:
2008-04-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Versamed iVent in the Transport of Patients Receiving Mechanical Ventilation
Sponsor:
Tufts Medical Center
Organization:
Study Overview
Official Title:
Evaluation of the Versamed iVent in the Transport of Patients Receiving Mechanical Ventilation
Status:
WITHDRAWN
Status Verified Date:
2017-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Unable to recruit adequately
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
iVent
Brief Summary:
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.
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 000 | None | None | View |