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Respiratory Endoscopy: Diagnostic Yield, Technical Factors and Complications

Respiratory Endoscopy: Diagnostic Yield, Technical Factors and Complications

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01374542
Enrollment
4000
Registered
2011-06-16
Start date
2011-06-30
Completion date
2021-01-01
Last updated
2021-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Bronchoscopy, Thoracoscopy

Brief summary

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

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.

Interventions

PROCEDURERespiratory endoscopy

Bronchoscopy, thoracoscopy, endobronchial ultrasound

Sponsors

Singapore General Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
10 Years to 100 Years
Healthy volunteers
No

Inclusion criteria

* All patients undergoing respiratory endoscopy at Singapore General Hospital

Exclusion criteria

* Clinical contra-indications to respiratory endoscopy

Design outcomes

Primary

MeasureTime frameDescription
Endoscopy diagnostic yield1 yearPositive and negative histology and microbiology yield
Endoscopy technical factors1 yearDuration, sedation requirements, consumables
Endoscopy safety1 yearComplication rate, need for escalation of care

Countries

Singapore

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 2, 2026