NCT05623631

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 30, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 28, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 28, 2021

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

November 8, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 21, 2022

Completed
Last Updated

November 21, 2022

Status Verified

November 1, 2022

Enrollment Period

6 months

First QC Date

November 8, 2022

Last Update Submit

November 18, 2022

Conditions

Keywords

AssessmentChest Tube InsertionRating Scale

Outcome Measures

Primary Outcomes (3)

  • Steps and errors presented in round 1

    The number of experts who propose a certain step or error

    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).

    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).

    one year

Study Arms (1)

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.

Other: Survey

Interventions

SurveyOTHER

Surveys were distributed using REDCap, and participants were asked to complete these within 5 weeks of receiving the invitation.

Delphi study

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Insufficient experience in CTI
  • Insufficient experience as an attending physician

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ghent University Hospital

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

MeSH Terms

Conditions

Thoracic Injuries

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Wouter Willaert, Prof, Dr.

    University Ghent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 8, 2022

First Posted

November 21, 2022

Study Start

March 30, 2021

Primary Completion

September 28, 2021

Study Completion

September 28, 2021

Last Updated

November 21, 2022

Record last verified: 2022-11

Locations