Chest TubesNCT05384327
Development and Validation of a Theoretical Test for Chest Tube Insertion
A study testing Interview and Multiple Choice Question (MCQ) Test in people with Chest Tubes and Cognitive Skill, run by University Ghent at 1 site in Belgium.
Trial summary
The goal of the proposed study design is to develop and gather validity evidence of a theoretical test about cognitive skills which are important when performing Chest Tube Insertion (CTI). This study consists of two parts: The development of the theoretical test and its items. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chest Tubes, Cognitive Skill
- What is being tested?
- Interview and Multiple Choice Question (MCQ) Test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteBelgium
- Study dates
- 5 May 2022to 18 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Content experts will be recruited from the departments of surgery, pulmonology, and emergency medicine of various hospitals in Flanders and the Netherlands. They must have finished their residency training and be actively involved in training of junior physicians. A maximum of six experts will be recruited, and a minimum of one physician from each department will be included.
- The novice group will attract medical students at Ghent University, within their 5th or 6th year of undergraduate training, while having no experience with CTI.
- The intermediate group will include residents of the departments of surgery, pulmonology and emergency medicine of Ghent University Hospital, within their 1st - 3rd year of residency training and must have placed less than 20 chest tubes themselves.
- The experienced group will be recruited from the departments of surgery, pulmonology, and emergency medicine of Ghent University Hospital. They must have finished the residency training in their respective fields and must have performed more than 20 CTI independently. The content experts will not be eligible for participation.
Who cannot join
- For the novice and intermediate group: having to much experience in CTI.
Trial locations and contacts
1 site in 1 country.
About this study
The goal of the proposed study design is to develop and gather validity evidence of a theoretical test about cognitive skills which are important when performing Chest Tube Insertion (CTI). This study consists of two parts:
- The development of the theoretical test and its items. The test content will be based on a broad literature search, and on semi-structured interviews with content experts.
- The subsequent collection of validity evidence for this theoretical test and final selection of the test items, by testing groups that differ based on their expertise. The item analysis and observed difference in mean score between the groups will provide the validity evidence.
- Conditions
- Chest Tubes, Cognitive Skill
- Being tested
- Interview, Multiple Choice Question (MCQ) Test
- Keywords
- Chest Tube, Assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterviewOther
Interviews consist of semi-structured interviews focused on the theoretical knowledge a physician should possess before placing chest tube insertions.
Multiple Choice Question (MCQ) TestOther
The test contains multiple choice questions based on these interviews. Participants will complete this test.
Validity evidence will be collected based on the results of this test.
| Study group | Role | What they receive |
|---|---|---|
| Interview | Other | Content experts who will be interviewed in order to collect their opinion on theoretical knowledge. Receives: Other: Interview |
| Novices | Other | Medical students who will complete the test Receives: Other: Multiple Choice Question (MCQ) Test |
| Intermediates | Other | Junior residents (surgery, pneumology, emergency medicine) who will complete the test. Receives: Other: Multiple Choice Question (MCQ) Test |
| Experienced | Other | Faculty members (surgery, pneumology, emergency medicine) who will complete the test. Receives: Other: Multiple Choice Question (MCQ) Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validity evidence for the theoretical test
Validity evidence following Messick's framework for a new theoretical test will be collected. The score will reflect the number of questions participants scored correctly; X/Y, where X=the number of questions answered correctly, and Y=the total number of questions. This score can be transformed in a percentage score accordingly. A higher score means the participant answered more questions correctly.
Measured: Participants are assessed once: the score of each participant is recorded immediately after completion of the test.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2022
- Study start5 May 2022
- Primary completion18 Apr 2023
- Study completion18 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chest TubesStudies of the same condition, open and under way.
- More trials run by University GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wouter Willaert, Prof. Dr., Principal investigator, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05384327
- Sponsor's protocol ID
- ID 5046
- Status last verified
- May 2023
- First submitted
- 13 May 2022
- Last updated
- 9 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of a Theoretical Test for Chest Tube Insertion
- ClinicalTrials.gov ID
- NCT05384327
- Acronym / sponsor ID
- ID 5046
- Conditions
- Chest Tubes, Cognitive Skill
- Keywords
- Chest Tube, Assessment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Study start
- 5 May 2022 (actual)
- Primary completion
- 18 Apr 2023 (actual)
- Study completion
- 18 Apr 2023 (actual)
- First posted
- 20 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of the proposed study design is to develop and gather validity evidence of a theoretical test about cognitive skills which are important when performing Chest Tube Insertion (CTI). This study consists of two parts:
- The development of the theoretical test and its items. The test content will be based on a broad literature search, and on semi-structured interviews with content experts.
- The subsequent collection of validity evidence for this theoretical test and final selection of the test items, by testing groups that differ based on their expertise. The item analysis and observed difference in mean score between the groups will provide the validity evidence.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Interview | Other | Other: InterviewContent experts who will be interviewed in order to collect their opinion on theoretical knowledge. |
| Novices | Other | Other: Multiple Choice Question (MCQ) TestMedical students who will complete the test |
| Intermediates | Other | Other: Multiple Choice Question (MCQ) TestJunior residents (surgery, pneumology, emergency medicine) who will complete the test. |
| Experienced | Other | Other: Multiple Choice Question (MCQ) TestFaculty members (surgery, pneumology, emergency medicine) who will complete the test. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Content experts will be recruited from the departments of surgery, pulmonology, and emergency medicine of various hospitals in Flanders and the Netherlands. They must have finished their residency training and be actively involved in training of junior physicians. A maximum of six experts will be recruited, and a minimum of one physician from each department will be included.
- The novice group will attract medical students at Ghent University, within their 5th or 6th year of undergraduate training, while having no experience with CTI.
- The intermediate group will include residents of the departments of surgery, pulmonology and emergency medicine of Ghent University Hospital, within their 1st - 3rd year of residency training and must have placed less than 20 chest tubes themselves.
- The experienced group will be recruited from the departments of surgery, pulmonology, and emergency medicine of Ghent University Hospital. They must have finished the residency training in their respective fields and must have performed more than 20 CTI independently. The content experts will not be eligible for participation.
Key exclusion criteria (1 listed)
- For the novice and intermediate group: having to much experience in CTI.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InterviewInterviews consist of semi-structured interviews focused on the theoretical knowledge a physician should possess before placing chest tube insertions. | Other | Interview |
| Multiple Choice Question (MCQ) TestThe test contains multiple choice questions based on these interviews. Participants will complete this test. Validity evidence will be collected based on the results of this test. | Other | Experienced, Intermediates, Novices |
Primary outcome
Validity evidence for the theoretical test
Time frame: Participants are assessed once: the score of each participant is recorded immediately after completion of the test.
Validity evidence following Messick's framework for a new theoretical test will be collected. The score will reflect the number of questions participants scored correctly; X/Y, where X=the number of questions answered correctly, and Y=the total number of questions. This score can be transformed in a percentage score accordingly. A higher score means the participant answered more questions correctly.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2023.
- Individual participant dataSharing planned: No
Related trials for Chest Tubes
Not yet recruiting
Effect of Warm Footbath Combined With Relaxation Exercise on Pain and Anxiety During Chest Tube Removal After Cardiac Surgery
Chest Tube Removal
RecruitingPhase 1/2
Rinatabart Sesutecan (Rina-S, PRO1184, GEN1184) for Advanced Solid Tumors (GCT1184-01/ PRO1184-001)
High Grade Epithelial Ovarian Cancer, High Grade Serous Ovarian Cancer
Recruiting
Effect of Box Breathing Before Chest Tube Removal After Open-Heart Surgery
Open-Heart Surgery
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
Recruiting
Hyperangulated vs Standard Videolaryngoscopy vs Direct Laryngoscopy for Double-Lumen Endobronchial Tube Intubation
Endobronchial Intubation, Double Lumen Tube Intubation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wouter Willaert, Prof. Dr. principal investigator
University Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interview and Multiple Choice Question (MCQ) Test in people with Chest Tubes and Cognitive Skill, run by University Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validity evidence for the theoretical test (time frame: Participants are assessed once: the score of each participant is recorded immediately after completion of the test.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2023.