Thoracic InjuryNCT05623631
Delphi Study to Identify Crucial Steps and Errors in the Placement of Chest Tubes
A study testing Survey in people with Thoracic Injury, run by University Ghent at 1 site in Belgium.
Trial summary
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Thoracic Injury
- What is being tested?
- Survey
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteBelgium
- Study dates
- 30 Mar 2021to 28 Sep 2021
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Insufficient experience in CTI
- Insufficient experience as an attending physician
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Thoracic Injury
- Being tested
- Survey
- Keywords
- Assessment, Chest Tube Insertion, Rating Scale
- Medical subject headings
- Thoracic Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveyOther
Surveys were distributed using REDCap, and participants were asked to complete these within 5 weeks of receiving the invitation.
| Study group | Role | What they receive |
|---|---|---|
| Delphi study | Other | 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. Receives: Other: Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Steps and errors presented in round 1
The number of experts who propose a certain step or error
Measured: one year
Number of steps and errors passing round 2
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).
Measured: one year
Inclusion of steps with their descriptive anchors
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).
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2022
- Study start30 Mar 2021
- Primary completion28 Sep 2021
- Study completion28 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracic InjuryStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 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
- NCT05623631
- Sponsor's protocol ID
- BC-09710
- Status last verified
- Nov 2022
- First submitted
- 8 Nov 2022
- Last updated
- 21 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Delphi Study to Identif Crucial Steps and Errors in the Placement of Chest Tubes
- ClinicalTrials.gov ID
- NCT05623631
- Acronym / sponsor ID
- BC-09710
- Conditions
- Thoracic Injury
- Keywords
- Assessment, Chest Tube Insertion, Rating Scale
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Study start
- 30 Mar 2021 (actual)
- Primary completion
- 28 Sep 2021 (actual)
- Study completion
- 28 Sep 2021 (actual)
- First posted
- 21 Nov 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 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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Delphi study | Other | Other: SurveyParticipants 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- Insufficient experience in CTI
- Insufficient experience as an attending physician
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 |
|---|---|---|
| SurveySurveys were distributed using REDCap, and participants were asked to complete these within 5 weeks of receiving the invitation. | Other | Delphi study |
Primary outcome
Steps and errors presented in round 1
Time frame: one year
The number of experts who propose a certain step or error
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).
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).
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 21 Nov 2022.
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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 Survey in people with Thoracic Injury, 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 6 inclusion and 2 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 21 Nov 2022. 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?
Steps and errors presented in round 1 (time frame: one year). The study lists 3 primary outcomes in all. 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 21 Nov 2022.