Procedural Skills Transfer in Bronchoscopy

NCT ID: NCT07168408

Last Updated: 2025-09-11

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 320 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-05-06
• Study Completion Date: 2026-12-31

Brief Summary

Brief summary The goal of this Feasibility study is to capture bronchoscopy data from patients (Group1) and bronchoscopists (Group 2) over a period of three years. The investigators wish to collect the pre-procedure CT scans and endoscopy videos of 300 patients. Up to 20 bronchoscopists will take part in the study

Primary outcomes

1. To collect imaging data from patients undergoing routine bronchoscopy procedures

2. To collect movement data from clinicians performing the routine bronchoscopy procedures using a sensory Glove

Secondary outcomes

1. Integrate the data gathered with procedure guidelines to develop a representation of procedure success using machine learning algorithms.

2. Develop an actionable knowledge base for bronchoscopy skill transfer to novice/untrained medical staff.

3. Investigate the feasibility of developing models of bronchoscopy procedures to develop training tools in the future

There are no additional samples or time commitments from the participants in Group 1.

The participants in Group 2 will be asked to answer a short questionnaire about their experience in performing bronchoscopies and will be asked to wear a sensory glove during the bronchoscopy procedure to capture their hand movements.

Detailed Description

Bronchoscopy is a procedure for visualising the inside of the lung and airways. During bronchoscopy, a thin tube is passed through the patient's mouth or nose, down the throat and into the lungs. This allows the practitioner to examine the patient's airways for abnormalities such as inflammation. Additionally, samples may be taken from inside the lungs.

Success rate of bronchoscopy relies on the practitioners experience. Patients undergoing bronchoscopy performed by novice bronchoscopists have an increased complication rate. Data from clinical practice suggest that bronchoscopy has a prolonged learning curve and trainees should perform a number of procedures, under supervision, to learn the technique.

In this study the investigators aim to capture bronchoscopy data from patients (Group1) and bronchoscopists (Group 2) over a period of 3 years. The investigators will collect the pre-procedure CT scans and endoscopy videos of 300 patients. Up to 20 bronchoscopists will take part in the study by answering a short questionnaire on their experience and wearing sensorized gloves which will record their hand movements during the procedure. the investigators aim to use this data to develop computer algorithms and simulators that will assist in the training of new bronchoscopists, decreasing the time required to learn the technique and improving patient safety.

Conditions

Respiratory Disease

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Group 1

Up to 300 patients undergoing routine bronchoscopy procedures. Patients will be asked permission to access previous CT scans and record video from the bronchoscopy procedure.

No interventions assigned to this group

Group 2

Up to 20 bronchoscopists. These participants will be asked a to complete a short questionnaire on their experience and will wear a sensorized glove to capture their hand movements during the procedure

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• over 16 years of age
• patients identified as requiring a bronchoscopy by their clinician
• patients must have had a CT scan in the 8 weeks prior to the procedure
• capacity to consent

• Suitably qualified bronchoscopists, this may include trainee bronchoscopists

Exclusion Criteria

• Clinicians who do not give consent to participate in the study
• Clinicians who are not comfortable performing bronchoscopy while wearing the lightweight glove

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Edinburgh

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Royal Infirmary of Edinburgh

Edinburgh, , United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Central Contacts

Adam Marshall

Role: CONTACT

adam.marshall@nhslothian.scot.nhs.uk

0131 6518293

katie Hamilton

Role: CONTACT

k.hamilton@ed.ac.uk

Facility Contacts

Katie Hamilton

Role: primary

07827288016

Other Identifiers

R&D 2021/0163

Identifier Type: -

Identifier Source: org_study_id