ISRCTN ISRCTN63799884
DOI https://doi.org/10.1186/ISRCTN63799884
Sponsor University of Milano-Bicocca
Funder Università degli Studi di Milano-Bicocca
Submission date
30/01/2026
Registration date
06/02/2026
Last edited
05/02/2026
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study aims
Residents in anesthesia and intensive care of the University of Milano-Bicocca without prior exposure to specific bronchoscopy training were enrolled to compare the AI-based to classical human-led training. Participants were assessed using the modified Bronchoscopy Skill and Task Assessment Tool (BSTAT) to evaluate the theoretical knowledge regarding the recognition of proximal bronchial anatomy (28 points total) and a practical component, assessing procedural positioning, airway wall trauma, correct intrabronchial scope position, and access to several tracheobronchial structures (27 points total). Of note, the proportion between the score driven by knowledge and practical component is similar to the original version of the BSTAT. Finally, similarly to the original BSTAT, the time required to complete the examination was recorded.

Who can participate?
Adult residents in anesthesia and intensive care.

What does the study involve?
Consent for the publication of data was obtained from residents. After a 1-hour frontal lecture on bronchoscopy and bronchial anatomy, the baseline bronchoscopy skills of all participants were tested using the BSTAT. Participants were thereafter randomized in a 1:1 ratio using sealed envelopes. The first group received classical training performed by an expert bronchoscopy instructor. The second group performed unsupervised training using the AI-based image recognition software. Each resident had 20 minutes of individual training and watched the individual training sessions of the other residents of her/his group. At the end of the training, each resident repeated the modified BSTAT. The assessment of the modified BSTAT was always performed by the same person, blinded to group allocation. Both baseline and post-training BSTAT examinations were conducted individually to prevent any learning effect from observation, ensuring that each resident's performance was based solely on their own training experience.

What are the possible benefits and risks of participating?
Benefits and risks not provided at time of registration

Where is the study run from?
University of Milan-Bicocca (Università degli Studi di Milano-Bicocca), Italy.

When is the study starting and how long is it expected to run for?
February 2024 to March 2024

Who is funding the study?
University of Milan-Bicocca (Università degli Studi di Milano-Bicocca), Italy.

Who is the main contact?
Prof Thomas Langer, thomas.langer@unimib.it

Contact information

Prof Thomas Langer
Principal investigator, Scientific, Public

University of Milan-Bicocca, Monza, Italy; Department of Anesthesia and Intensive Care Medicine, Niguarda Ca' Granda
Milano
20162
Italy

Phone +39 0264448580
Email thomas.langer@unimib.it

Study information

Primary study designInterventional
AllocationRandomized controlled trial
MaskingOpen (masking not used)
ControlActive
AssignmentCrossover
PurposeEducational- training
Scientific titleArtificial intelligence-based image recognition in bronchoscopy: a randomized controlled trial for training evaluation in intensive care residents
Study acronymAI-BRITE Trial
Study objectivesThe primary aim of this study is to compare the performance of residents in flexible bronchoscopy after specific training, either AI-based or human-led. Specifically, we hypothesize that the Bronchoscopy Skill and Task Assessment Tool (BSTAT) scores of residents undergoing AI-based training are similar to those assigned to human-led training.
Ethics approval(s)Ethics approval not required
Health condition(s) or problem(s) studiedAnesthesia Resident
InterventionParticipants are randomized in a 1:1 ratio using sealed envelopes. The first group receives classical training conducted by an expert bronchoscopy instructor. The second group performs unsupervised training using AI-based image recognition software. Each resident has 20 minutes of individual training and watches the individual training sessions of the other residents in her/his group. At the end of the training, each resident repeats the modified BSTAT.
Intervention typeOther
Primary outcome measure(s)
  1. Bronchoscopy knowledge and positioning skills measured using modified Bronchoscopy Skill and Task Assessment Tool (BSTAT), the minimum score is 0 (worst performance), and the maximum is 55 (perfect performance), at baseline (before training) and after training
Key secondary outcome measure(s)
  1. The performance of residents in flexible bronchoscopy measured using the theoretical part of modified BSTAT, scores range from a minimum of 0 (worst performance) to a maximum of 27 (best performance), at baseline (before training) and after training
Completion date01/03/2024

Eligibility

Participant type(s)
Age groupMixed
Lower age limit18 Years
Upper age limit99 Years
SexAll
Target sample size at registration22
Total final enrolment22
Key inclusion criteria1. Residents in anesthesia and intensive care
2. Without prior exposure to specific bronchoscopy training
3. Accepted to participate
Key exclusion criteriaNot meeting the key inclusion criteria
Date of first enrolment01/02/2024
Date of final enrolment29/02/2024

Locations

Countries of recruitment

  • Italy

Study participating centres

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot expected to be made available
IPD sharing plan

Editorial Notes

05/02/2026: Study’s existence confirmed by the Head of the Department of Medicine and Surgery of the University of Milano-Bicocca, Italy.