Complications After Endosonography and Guided Bronchoscopy

April 13, 2022 updated by: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

701

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Lazio
      • Roma, Lazio, Italy, 00168
        • Fondazione Policlinico Universitario A. Gemelli IRCCS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with indication to guided bronchoscopy, endosonography, or both-

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of severe complications
Time Frame: 30 days
30 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Mortality
Time Frame: 30 days
30 days
Overall incidence of complications
Time Frame: 30 days
30 days
Risk factors associated with severe complications
Time Frame: 30 days
30 days
Rate of unplanned hospital admissions
Time Frame: 30 days
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Investigators

  • Principal Investigator: Rocco Trisolini, MD, Fondazione Policlinico Universitario A. Gemelli IRCS, Università Cattolica del Sacro Cuore

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 27, 2020

Primary Completion (Actual)

February 7, 2022

Study Completion (Actual)

March 8, 2022

Study Registration Dates

First Submitted

November 3, 2020

First Submitted That Met QC Criteria

November 3, 2020

First Posted (Actual)

November 9, 2020

Study Record Updates

Last Update Posted (Actual)

April 14, 2022

Last Update Submitted That Met QC Criteria

April 13, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ST1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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