Respiratory Endoscopy: Diagnostic Yield, Technical Factors and Complications

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Respiratory Endoscopy: Diagnostic Yield, Technical Factors and Complications

Conditions
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Lung Neoplasm, Lung Diseases, Interstitial, Respiratory Tract Infections, Pleural Effusions

Intervention / Treatment
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* Procedure: Respiratory endoscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients undergoing respiratory endoscopy at Singapore General Hospital Exclusion Criteria: Clinical contra-indications to respiratory endoscopy

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Respiratory endoscopy patients<br>Patients undergoing respiratory endoscopy at Singapore General Hospital | Procedure: Respiratory endoscopy<br>* Bronchoscopy, thoracoscopy, endobronchial ultrasound<br>* Other names: Endobronchial ultrasound-EBUS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endoscopy diagnostic yield | Positive and negative histology and microbiology yield | 1 year | 
| Endoscopy technical factors | Duration, sedation requirements, consumables | 1 year | 
| Endoscopy safety | Complication rate, need for escalation of care | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bronchoscopy, Thoracoscopy