NCT00652756

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

April 1, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 4, 2008

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

April 6, 2017

Status Verified

April 1, 2017

Enrollment Period

4.5 years

First QC Date

April 1, 2008

Last Update Submit

April 5, 2017

Conditions

Respiration, Artificial

Keywords

Respiration, ArtificialTransportation of PatientsIntubation, IntratrachealTracheostomy

Outcome Measures

Primary Outcomes (1)

  • To determine whether using a ventilator during patient transport has better outcomes than the current approach to transport.

    One year (estimated)

Study Arms (2)

1

EXPERIMENTAL

Patient is placed on a transport ventilator.

Device: Use of ventilator during patient transport (Versamed iVent)

2

OTHER

Patient is ventilated using the current standard at this institution.

Other: Bag-valve ventilation

Interventions

Use of ventilator during patient transport (Versamed iVent)DEVICE

The goal of the transport ventilator is to provide optimal ventilation.

Also known as: Versamed iVent ventilator
1
Bag-valve ventilationOTHER

Use of bag-valve ventilation during patient transport.

Also known as: Use of manual resuscitator during transport.
2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Patient must be at least eighteen years of age.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tufts Medical Center

Boston, Massachusetts, 01770, United States

Location

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Nicholas S. Hill, MD

    Tufts Medical Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 1, 2008

First Posted

April 4, 2008

Study Start

August 1, 2007

Primary Completion

February 1, 2012

Study Completion

February 1, 2012

Last Updated

April 6, 2017

Record last verified: 2017-04

Locations

US(1)