Respiratory Endoscopy: Diagnostic Yield, Technical Factors and Complications

Respiratory Tract Infections Clinical Trial

Official title:

Respiratory Endoscopy: Diagnostic Yield, Technical Factors and Complications

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01374542
• Other study ID #: 2011/350/C
• Status: Completed
• Start date: June 2011
• Est. completion date: January 1, 2021

Study information

• Verified date: September 2021
• Source: Singapore General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4000
• Est. completion date: January 1, 2021
• Est. primary completion date: January 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 100 Years

Eligibility

Inclusion Criteria:

• All patients undergoing respiratory endoscopy at Singapore General Hospital

Exclusion Criteria:

• Clinical contra-indications to respiratory endoscopy

Related Conditions & MeSH terms

• Lung Diseases
• Lung Diseases, Interstitial
• Lung Neoplasm
• Lung Neoplasms
• Pleural Effusion
• Pleural Effusions
• Respiratory Tract Infections

Intervention

Procedure:
• Respiratory endoscopy
Bronchoscopy, thoracoscopy, endobronchial ultrasound

Locations

Country	Name	City	State
Singapore	Singapore General Hospital	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Singapore General Hospital

Country where clinical trial is conducted

Singapore, 

References & Publications (2)

Kawaraya M, Gemba K, Ueoka H, Nishii K, Kiura K, Kodani T, Tabata M, Shibayama T, Kitajima T, Tanimoto M. Evaluation of various cytological examinations by bronchoscopy in the diagnosis of peripheral lung cancer. Br J Cancer. 2003 Nov 17;89(10):1885-8. — View Citation

Torrington KG, Kern JD. The utility of fiberoptic bronchoscopy in the evaluation of the solitary pulmonary nodule. Chest. 1993 Oct;104(4):1021-4. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endoscopy diagnostic yield	Positive and negative histology and microbiology yield	1 year
Primary	Endoscopy technical factors	Duration, sedation requirements, consumables	1 year
Primary	Endoscopy safety	Complication rate, need for escalation of care	1 year