NCT00495963

Brief Summary

Background and Objectives: There is a need to validate and suggest easy and less costly diagnostic method for diagnosis of ventilator-associated pneumonia in developing country. The study was performed to compare available methods for the diagnosis and to characterize the organisms causing VAP. Design and Methods: All patients on mechanical ventilation for more than 48 hours and simplified CPIS ≥ 6 were enrolled prospectively. Four diagnostic procedures, endotracheal aspiration (ETA), blind bronchial sampling (BBS), blind bronchoalveolar lavage (blind BAL) and bronchoscopic BAL (BAL) were performed in same sequence within 12 hours. The bacterial density ≥ 104 cfu/ mL BAL samples were taken as reference standard.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Jan 2003

Shorter than P25 for phase_3

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

January 1, 2003

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2003

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

July 2, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 3, 2007

Completed
Last Updated

October 17, 2008

Status Verified

July 1, 2007

First QC Date

July 2, 2007

Last Update Submit

October 16, 2008

Conditions

Ventilator Associated Pneumonia

Keywords

Mechanical ventilation, Ventilator- associated pneumonia, Bronchoalveolar lavage, Pediatric intensive care unit, Flexible bronchoscopy, Critical care

Interventions

bronchoaleolar lavagePROCEDURE
BronchoscopyPROCEDURE

Eligibility Criteria

Age4 Weeks - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children on mechanical ventilation for more than 72 hours and having simplified clinical pulmonary infection score more than 6 were included in study.

You may not qualify if:

  • Age less than 1 month.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sir Ganga Ram Hospital

New Delhi, New Delhi, 110060, India

Location

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated

Interventions

Bronchoscopy

Condition Hierarchy (Ancestors)

Healthcare-Associated PneumoniaCross InfectionInfectionsPneumoniaRespiratory Tract InfectionsLung DiseasesRespiratory Tract DiseasesIatrogenic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Anil Sachdev, MD

    Sir Ganga Ram Hospital Rajinder Nagar, New Delhi, India

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 2, 2007

First Posted

July 3, 2007

Study Start

January 1, 2003

Study Completion

September 1, 2003

Last Updated

October 17, 2008

Record last verified: 2007-07

Locations

IN(1)