Complications After Endosonography and Guided Bronchoscopy
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Other)
Overall Status
Completed
CT.gov ID
NCT04621344
Collaborator
(none)
701
1
16.3
42.9
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational
Actual Enrollment
:
701 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
30-DAY MORBIDITY, MORTALITY AND UNPLANNED HOSPITAL ADMISSIONS AFTER GUIDED-BRONCHOSCOPY AND ENDOSONOGRAPHY
Actual Study Start Date
:
Oct 27, 2020
Actual Primary Completion Date
:
Feb 7, 2022
Actual Study Completion Date
:
Mar 8, 2022
Outcome Measures
Primary Outcome Measures
- Incidence of severe complications [30 days]
Secondary Outcome Measures
- Overall incidence of complications [30 days]
- Risk factors associated with severe complications [30 days]
- Rate of unplanned hospital admissions [30 days]
- Mortality [30 days]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Fondazione Policlinico Universitario A. Gemelli IRCCS | Roma | Lazio | Italy | 00168 |
Sponsors and Collaborators
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Investigators
- Principal Investigator: Rocco Trisolini, MD, Fondazione Policlinico Universitario A. Gemelli IRCS, Università Cattolica del Sacro Cuore
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
ClinicalTrials.gov Identifier:
NCT04621344
Other Study ID Numbers:
- ST1
First Posted:
Nov 9, 2020
Last Update Posted:
Apr 14, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Fondazione Policlinico Universitario Agostino Gemelli IRCCS