NCT00997555

Brief Summary

The investigators hypothesize that the scheduled use of bronchoscopy on a regular basis after inhalation injury in burn patients will improve outcome by providing pulmonary hygiene, decrease the incidence of pneumonia, and detect pneumonia earlier than standard treatment without bronchoscopy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

October 1, 2009

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

October 15, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 19, 2009

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
7 months until next milestone

Results Posted

Study results publicly available

January 31, 2013

Completed
Last Updated

January 31, 2013

Status Verified

December 1, 2012

Enrollment Period

2.8 years

First QC Date

October 15, 2009

Results QC Date

September 4, 2012

Last Update Submit

December 22, 2012

Conditions

Inhalation InjuryPneumonitisPneumonia

Keywords

inhalationbronchoscopyburnpneumonia

Outcome Measures

Primary Outcomes (2)

  • All Cause Mortality

    Bronchoscopy group deaths n=0. Control group deaths n=1.

    until death or discharge from hospital, data reviewed every 6 months

  • Respiratory Associated Mortality

    Bronchoscopy group deaths n=0. Control group deaths n=1.

    until death or discharge from hospital, data reviewed every 6 months

Secondary Outcomes (4)

  • Incidence of Pneumonia

    until discharge from the hospital, data reviewed every 6 months

  • Length of Mechanical Ventilation

    until discharge from hospital, data reviewed every 6 months

  • Length of ICU Stay

    until discharge from hospital, data reviewed every 6 months

  • Length of Hospital Stay

    until discharge from hospital, data reviewed every 6 months

Study Arms (2)

bronchoscopy intervention group

EXPERIMENTAL

Group undergoing scheduled bronchoscopy.

Procedure: bronchoscopy

Control group

NO INTERVENTION

Standard treatment without scheduled bronchoscopy.

Interventions

bronchoscopyPROCEDURE

Scheduled bronchoscopy.

bronchoscopy intervention group

Eligibility Criteria

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

You may qualify if:

  • Any burned patient arriving intubated on mechanical ventilation OR requiring mechanical ventilation within 48 hours of admission AND
  • \> 18 years old AND
  • patient believed to be able to survive more than 48 hours after arrival (not likely to be made DNR or comfort care) including:
  • any methamphetamine explosion or
  • any burn associated with fire (not chemical) of the face or blast injury to the face or
  • confined in a burning space for more than 10 minutes or
  • any burn with carbonaceous material around the nose or mouth or
  • any burn \> 15% TBSA associated with fire (not chemical) or
  • any burn associated with an explosion in a confined space.

You may not qualify if:

  • Likely to die within 48 hours based upon severity of injury.
  • Less than 18 years old.
  • Burned patient transferred to our facility already on mechanical ventilation for more than 48 hours.
  • Patient already on antibiotics for another reason.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hurley Medical Center

Flint, Michigan, 48503, United States

Location

MeSH Terms

Conditions

PneumoniaRespiratory AspirationBurns

Interventions

Bronchoscopy

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract DiseasesRespiration DisordersPathologic ProcessesPathological Conditions, Signs and SymptomsWounds and Injuries

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalMinimally Invasive Surgical ProceduresSurgical Procedures, OperativePulmonary Surgical ProceduresThoracic Surgical Procedures

Results Point of Contact

Title
John Alfred Carr, MD
Organization
Hurley Medical Center
heartandbones@yahoo.com
810-262-4993

Study Officials

  • John A Carr, MD

    Hurley Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

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

October 15, 2009

First Posted

October 19, 2009

Study Start

October 1, 2009

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

January 31, 2013

Results First Posted

January 31, 2013

Record last verified: 2012-12

Locations

US(1)