Complications After Endosonography and Guided Bronchoscopy

Complication of Bronchoscopy Clinical Trial

Official title:

30-DAY MORBIDITY, MORTALITY AND UNPLANNED HOSPITAL ADMISSIONS AFTER GUIDED-BRONCHOSCOPY AND ENDOSONOGRAPHY

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04621344
• Other study ID #: ST1
• Status: Completed
• Start date: October 27, 2020
• Est. completion date: March 8, 2022

Study information

• Verified date: April 2022
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 701
• Est. completion date: March 8, 2022
• Est. primary completion date: February 7, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Complication of Bronchoscopy

Intervention

Diagnostic Test:
• Guided bronchoscopy and/or endosonography
Endoscopic procedures aimed at sampling of intrathoracic lymph nodes or pulmonary lesions

Locations

Country	Name	City	State
Italy	Fondazione Policlinico Universitario A. Gemelli IRCCS	Roma	Lazio

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of severe complications		30 days
Secondary	Overall incidence of complications		30 days
Secondary	Risk factors associated with severe complications		30 days
Secondary	Rate of unplanned hospital admissions		30 days
Secondary	Mortality		30 days