Complications After Endosonography and Guided Bronchoscopy

Completed

• Conditions: Complication of Bronchoscopy

• Registration Number: NCT04621344
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Brief Summary

The present study aims to investigate prospectively and systematically the direct and indirect complications occurring within 30 days after guided-bronchoscopy and/or endosonography. The results of the study should reliably help clarify further incidence, pattern, risk factors, and outcomes for both immediate and late complications associated with these key diagnostic procedures.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-27
• Study First Submitted: 2020-11-03
• Study First Submitted QC: 2020-11-03
• Study First Posted: 2020-11-09
• Primary Completion: 2022-02-07
• Study Completion: 2022-03-08
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-13
• Last Update Posted: 2022-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 701

Inclusion Criteria

• Age >18 years,
• Indication to undergo bronchoscopy, endosonography, or both.
• Signed informed consent

Exclusion Criteria

• Absolute contraindications to the bronchoscopic examination based on international guidelines [31].
• Platelet count <50000

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of severe complications	30 days

Secondary Outcome Measures

Name	Time	Method
Mortality	30 days
Overall incidence of complications	30 days
Risk factors associated with severe complications	30 days
Rate of unplanned hospital admissions	30 days

Trial Locations

Locations (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS; 🇮🇹 Roma, Lazio, Italy