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Diagnosis of Ventilator- Associated Pneumonia in Children: A Comparative Study of Bronchoscopic and Non-Bronchoscopic Methods

This study has been completed.
Sponsor:
Information provided by:
Sir Ganga Ram Hospital
ClinicalTrials.gov Identifier:
NCT00495963
First received: July 2, 2007
Last updated: October 16, 2008
Last verified: July 2007
History of Changes
  Purpose

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.


Condition Intervention Phase
Ventilator Associated Pneumonia
 Procedure: bronchoaleolar lavage
Procedure: Bronchoscopy
 Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic

Resource links provided by NLM:

MedlinePlus related topics: Pneumonia
U.S. FDA Resources

Further study details as provided by Sir Ganga Ram Hospital:

Study Start Date: January 2003
Study Completion Date: September 2003
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Age less than 1 month.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00495963

Locations
India
Sir Ganga Ram Hospital
New Delhi, India, 110060
Sponsors and Collaborators
Sir Ganga Ram Hospital
Investigators
Principal Investigator: Anil Sachdev, MD Sir Ganga Ram Hospital Rajinder Nagar, New Delhi, India
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00495963     History of Changes
Other Study ID Numbers: Ehics committee, Sir Ganga Ram
Study First Received: July 2, 2007
Last Updated: October 16, 2008
Health Authority: India:Department of Acedemics, Sir Ganga Ram Hospital, Rajinder Nagar, New Delhi.

Keywords provided by Sir Ganga Ram Hospital:
Mechanical ventilation, Ventilator- associated pneumonia, Bronchoalveolar lavage, Pediatric intensive care unit, Flexible bronchoscopy, Critical care

Additional relevant MeSH terms:
Pneumonia
Pneumonia, Ventilator-Associated
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
 Cross Infection
Infection
Ventilator-Induced Lung Injury
Lung Injury

ClinicalTrials.gov processed this record on May 19, 2013