- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05623631
Delphi Study to Identify Crucial Steps and Errors in the Placement of Chest Tubes
November 18, 2022 updated by: University Ghent
Delphi Study to Identif Crucial Steps and Errors in the Placement of Chest Tubes
The goal of this Delphi study is to identify the crucial steps and the errors in Chest Tube Insertion (CTI).
These steps and errors will be used for the development of a new assessment tool based on international consensus.
Study Overview
Study Type
Interventional
Enrollment (Actual)
29
Phase
- Not Applicable
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
-
-
Oost-Vlaanderen
-
Ghent, Oost-Vlaanderen, Belgium, 9000
- Ghent University Hospital
-
-
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
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Must be experts in their respective fields.
- Must hold a degree of Master in Medicine
- Must have finished the residency training specific to their field (be an attending physician)
- Must have 5 years post-residency experience
- Must have performed at least 50 CTIs independently in their career
- Must have an interest in educating and guiding junior residents in their training.
Exclusion Criteria:
- Insufficient experience in CTI
- Insufficient experience as an attending physician
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
- Primary Purpose: OTHER
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
OTHER: Delphi study
Participants were asked to complete three rounds of surveys.
These surveys collected information on which steps and errors can occur during CTI, and which of these should be included in an assessment tool.
|
Surveys were distributed using REDCap, and participants were asked to complete these within 5 weeks of receiving the invitation.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Steps and errors presented in round 1
Time Frame: one year
|
The number of experts who propose a certain step or error
|
one year
|
|
Number of steps and errors passing round 2
Time Frame: one year
|
The number of experts who agree on the inclusion of each step or error in the assessment tool on a 5-point Likert scale (Strongly disagree - Disagree - Neutral - Agree - Strongly Agree).
|
one year
|
|
Inclusion of steps with their descriptive anchors
Time Frame: one year
|
The number of experts who agree on the inclusion of each step with their descriptive anchors in the assessment tool on a 5-point Likert scale (Strongly disagree - Disagree - Neutral - Agree - Strongly Agree).
|
one year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Wouter Willaert, Prof, Dr., University Ghent
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)
March 30, 2021
Primary Completion (ACTUAL)
September 28, 2021
Study Completion (ACTUAL)
September 28, 2021
Study Registration Dates
First Submitted
November 8, 2022
First Submitted That Met QC Criteria
November 18, 2022
First Posted (ACTUAL)
November 21, 2022
Study Record Updates
Last Update Posted (ACTUAL)
November 21, 2022
Last Update Submitted That Met QC Criteria
November 18, 2022
Last Verified
November 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BC-09710
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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