NCT00351741

Brief Summary

The purpose of this study is to compare High Frequency Pressure Ventilation (HFPV) to conventional mechanical ventilation. Hypothesis: Patients placed on HFPV will have significantly higher number of ventilator-free days compared to patients placed on a conventional volume mode.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

July 1, 2006

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

July 11, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 13, 2006

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
11 months until next milestone

Results Posted

Study results publicly available

December 28, 2010

Completed
Last Updated

September 21, 2015

Status Verified

September 1, 2015

Enrollment Period

3.6 years

First QC Date

July 11, 2006

Results QC Date

July 16, 2010

Last Update Submit

September 8, 2015

Conditions

Burns

Keywords

Burns

Outcome Measures

Primary Outcomes (1)

  • Ventilator-free Days During the First 28 Days

    The primary end point was ventilator-free days in the first 28 days, defined as the number of days after randomization from day 0 to day 28 alive without ventilator assistance for at least 48 consecutive hrs.

    28 days

Secondary Outcomes (6)

  • Days Free From Nonpulmonary Organ Failure

    28

  • Death

    during hospitalization

  • Ventilator Associated Pneumonia

    28 days

  • Need for Rescue Ventilator

    28 days

  • Barotrauma

    28 days

  • +1 more secondary outcomes

Study Arms (2)

High Frequency

EXPERIMENTAL

Provide standard ventilatory support for burn patients utilizing high frequency percussive ventilation

Device: Ventilation - High Frequency Percussive Ventilation

Conventional

ACTIVE COMPARATOR

Standard ventilator support for non burned patients utilizing lung protective low tidal volume ventilation

Device: Ventilation - ARDSnet

Interventions

Ventilation - High Frequency Percussive VentilationDEVICE

Ventilatory support delivering high frequency percussive ventilation using the Volumetric Diffusive Respirator

Also known as: High Frequency Percussive Ventilation, Volumetric Diffusive Respirator
High Frequency
Ventilation - ARDSnetDEVICE

Respiratory support with a conventional mode of ventilation using a conventional ventilator (Draeger Evita XL)

Also known as: Lung Protective Ventilation, Low Tidal Volume Strategy, Conventional Mechanical Ventilation
Conventional

Eligibility Criteria

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

You may qualify if:

  • Patients who are deemed to require ventilatory support for more than 24 hours from the time of screening.

You may not qualify if:

  • Anticipated extubation within 24 hours of screening
  • Patients who are pregnant Patients not expected to survive for more than 24 hours

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

United States Army Institute of Surgical Research

Fort Sam Houston, Texas, 78234, United States

Location

Related Publications (3)

  • Salim A, Martin M. High-frequency percussive ventilation. Crit Care Med. 2005 Mar;33(3 Suppl):S241-5. doi: 10.1097/01.ccm.0000155921.32083.ce.

    PMID: 15753734BACKGROUND

  • Acute Respiratory Distress Syndrome Network; Brower RG, Matthay MA, Morris A, Schoenfeld D, Thompson BT, Wheeler A. Ventilation with lower tidal volumes as compared with traditional tidal volumes for acute lung injury and the acute respiratory distress syndrome. N Engl J Med. 2000 May 4;342(18):1301-8. doi: 10.1056/NEJM200005043421801.

    PMID: 10793162BACKGROUND

  • Chung KK, Wolf SE, Renz EM, Allan PF, Aden JK, Merrill GA, Shelhamer MC, King BT, White CE, Bell DG, Schwacha MG, Wanek SM, Wade CE, Holcomb JB, Blackbourne LH, Cancio LC. High-frequency percussive ventilation and low tidal volume ventilation in burns: a randomized controlled trial. Crit Care Med. 2010 Oct;38(10):1970-7. doi: 10.1097/CCM.0b013e3181eb9d0b.

    PMID: 20639746DERIVED

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Limitations and Caveats

After 3 yrs of enrollment, interim analysis revealed a significant number of subjects in the Conventional arm required rescue, which served as the trigger to close the study to further enrollment.

Results Point of Contact

Title
Principal Investigator
Organization
USAISR
kevin.chung@us.army.mil
210-916-3054

Study Officials

  • Kevin K Chung, MD

    United States Army Insitute of Surgical Research

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Administrator

Study Record Dates

First Submitted

July 11, 2006

First Posted

July 13, 2006

Study Start

July 1, 2006

Primary Completion

February 1, 2010

Study Completion

February 1, 2010

Last Updated

September 21, 2015

Results First Posted

December 28, 2010

Record last verified: 2015-09

Locations

US(1)