Respiratory Endoscopy: Diagnostic Yield, Technical Factors and Complications

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Singapore General Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Singapore General Hospital
ClinicalTrials.gov Identifier:
NCT01374542
First received: June 14, 2011
Last updated: June 15, 2011
Last verified: June 2011
  Purpose

Background: Respiratory endoscopy comprises flexible bronchoscopy and medical thoracoscopy. The diagnostic yield, technical factors and complications for all patient sub-populations is still not clearly defined. This may result in inappropriate or even dangerous application of such procedures. The aim of the study is to collect data on these aspects of respiratory endoscopy and identify important trends, as well as, areas for improvement. This data will also provide baseline comparative data for new bronchoscopic techniques such as endobronchial ultrasound and navigational bronchoscopy.

Method: Prospective data collection. Technical details regarding these procedures are currently keyed into the OTM system by the endoscopy operators for documentation and billing. The department of Respiratory and Critical Care Medicine gets monthly downloads of all the fields from the OTM system for audit purposes.(See data collection form) The research project proposes to make the data non identifiable by removing the patient's name and IC number. Additionally the yield of the procedure will be checked by a chart review of the histology and microbiology results. There are no restrictions on patient recruitment because all procedures will be performed for clinical indications only and no patient will be recruited for the sole purpose of the study. Waiver of consent has been approved by the IRB.


Condition Intervention
Lung Neoplasm
Lung Diseases, Interstitial
Respiratory Tract Infections
Pleural Effusions
Procedure: Respiratory endoscopy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Respiratory Endoscopy: Diagnostic Yield, Technical Factors and Complications

Resource links provided by NLM:


Further study details as provided by Singapore General Hospital:

Primary Outcome Measures:
  • Endoscopy diagnostic yield [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Positive and negative histology and microbiology yield

  • Endoscopy technical factors [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Duration, sedation requirements, consumables

  • Endoscopy safety [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Complication rate, need for escalation of care


Estimated Enrollment: 1000
Study Start Date: June 2011
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Respiratory endoscopy patients
Patients undergoing respiratory endoscopy at Singapore General Hospital
Procedure: Respiratory endoscopy
Bronchoscopy, thoracoscopy, endobronchial ultrasound
Other Names:
  • Bronchoscopy-Flexible bronchoscopy
  • Thoracoscopy-Pleuroscopy
  • Endobronchial ultrasound-EBUS

Detailed Description:

Background: Respiratory endoscopy comprises flexible bronchoscopy and medical thoracoscopy. The diagnostic yield, technical factors and complications for all patient sub-populations is still not clearly defined. This may result in inappropriate or even dangerous application of such procedures. The aim of the study is to collect data on these aspects of respiratory endoscopy and identify important trends, as well as, areas for improvement. This data will also provide baseline comparative data for new bronchoscopic techniques such as endobronchial ultrasound and navigational bronchoscopy.

Method: Prospective data collection. Technical details regarding these procedures are currently keyed into the OTM system by the endoscopy operators for documentation and billing. The department of Respiratory and Critical Care Medicine gets monthly downloads of all the fields from the OTM system for audit purposes.(See data collection form) The research project proposes to make the data non identifiable by removing the patient's name and IC number. Additionally the yield of the procedure will be checked by a chart review of the histology and microbiology results. There are no restrictions on patient recruitment because all procedures will be performed for clinical indications only and no patient will be recruited for the sole purpose of the study. Waiver of consent has been obtained by the IRB. The current estimated bronchoscopy load is 1000/year and data will be kept in the trial co-coordinator's computer in a locked office. The investigators hope to run the database for 3 years initially.

  Eligibility

Ages Eligible for Study:   10 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

All patients undergoing respiratory endoscopy at Singapore General Hospital

Criteria

Inclusion Criteria:

  • All patients undergoing respiratory endoscopy at Singapore General Hospital

Exclusion Criteria:

  • Clinical contra-indications to respiratory endoscopy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01374542

Contacts
Contact: Chwee Bee Yap 65 63214700 yap.chwee.bee@sgh.com.sg
Contact: Devanand Anantham, MRCP 65 63214700 anantham.devanand@sgh.com.sg

Locations
Singapore
Singapore General Hospital Recruiting
Singapore, Singapore, 168753
Contact: Chwee Bee Yap    65 63214700    yap.chwee.bee@sgh.com.sg   
Contact: Devanand Anantham, MRCP    65 63214700    anantham.devanand@sgh.com.sg   
Principal Investigator: Devanand Anantham, MRCP         
Sponsors and Collaborators
Singapore General Hospital
Investigators
Principal Investigator: Devanand Anantham, MRCP Singapore General Hospital
  More Information

Publications:
Responsible Party: Devanand Anantham/Dr, Sinagpore General Hospital
ClinicalTrials.gov Identifier: NCT01374542     History of Changes
Other Study ID Numbers: 2011/350/C
Study First Received: June 14, 2011
Last Updated: June 15, 2011
Health Authority: Singapore: Health Sciences Authority

Keywords provided by Singapore General Hospital:
Bronchoscopy
Thoracoscopy

Additional relevant MeSH terms:
Lung Diseases, Interstitial
Lung Diseases
Pleural Effusion
Respiratory Tract Infections
Lung Neoplasms
Respiratory Tract Diseases
Pleural Diseases
Infection
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms

ClinicalTrials.gov processed this record on October 01, 2014