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Artificial Intelligence Assistance in Endoscopy RecoveryAIVR2NCT06923059

AI Assistance in GI Endoscopy Recovery Assessment

A study testing AI-assisted endoscopy recovery assessment in people with Artificial Intelligence Assistance in Endoscopy Recovery and AI Validation, run by Chinese University of Hong Kong at 1 site in Hong Kong.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

We have developed and validated an AI model to assess endoscopy recovery status based on 400 voice recordings from 200 patients. This model has a mean accuracy of 84.14% with a mean area under the curve (AUC) of 0.91. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
AI-assisted endoscopy recovery assessment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
460 participants
Where
1 siteHong Kong
Study dates
1 Apr 2025to 30 Jun 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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

  • speak Cantonese;
  • aged ≥18 years;
  • undergoing outpatient sedated gastrointestinal endoscopy of any indication in Combined Endoscopy Unit at Alice Ho Miu Ling Nethersole Hospital

Who cannot join

  • patients who are unable to provide consent or communicate verbally

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Hong Kong1 site
  • Alice Ho Miu Ling Nethersole Hospital

    New Territories

    Felix SIA, 852-26370428, felixsia@cuhk.edu.hk

Other trials in Hong Kong

About this study

Official title: Effectiveness of Artificial Intelligence-assisted Recovery Assessment After Outpatient Gastrointestinal Endoscopy. A Pilot Double-blind Randomized Controlled Trial.

We have developed and validated an AI model to assess endoscopy recovery status based on 400 voice recordings from 200 patients. This model has a mean accuracy of 84.14% with a mean area under the curve (AUC) of 0.91.

To further enhance the performance of this AI model, we plan to collect additional voice recordings to retrain it. We also plan to develop a mobile application of this AI model for effectiveness evaluation in a pilot randomized controlled trial (RCT) setting. Endoscopy nurses in Hong Kong were invited to participate in a survey study. Therefore, we believe implementation of AI model in clinical practice will be well accepted by endoscopy nurses in Hong Kong.

Read the detailed description

Globally, cancer is one of the leading causes of death. 70% of this global burden of cancer is attributed to premature mortality, of which 70% of these deaths are preventable and 30% are treatable Globally, cancer is one of the leading causes of death. 70% of this global burden of cancer is attributed to premature mortality, of which 70% of these deaths are preventable and 30% are treatable . Among the ten most common causes of cancer death worldwide, one third are digestive cancers. These can be diagnosed by outpatient gastrointestinal endoscopy. These include colorectal cancer (via colonoscopy), as well as esophageal and gastric cancer (via esophagogastroduodenoscopy). In addition to diagnosis, outpatient endoscopy is also widely used for cancer screening and surveillance. With the global increase in the aging population and heightened awareness of cancer screening, the demand for endoscopy services for cancer screening, diagnosis and surveillance is rapidly increasing to achieve the goal of early cancer detection and treatment.

To reduce patients' fear and anxiety regarding endoscopy and to relieve the associated pain and discomfort, most endoscopies are performed under sedation. It is known that the sedative effect lasts longer than needed for diagnostic or basic therapeutic colonoscopies, which can mostly be done within 30 minutes. Patients are closely monitored at the recovery room after the completion of the endoscopy, and the recovery nurse assesses the consciousness of the patient after a fixed period of time, typically 60 minutes, or every 10 minutes until the standardized discharge criteria are met. In an outpatient setting, it is important to determine if patients are fully recovered from the sedative effect and have reached a clinically stable state before discharging them from the hospital with the accompany of a responsible adult. The assessment of the standardized discharge criteria includes the followings: 1) return of consciousness to baseline level; 2) vital signs are within normal limits; 3) respiratory status is not compromised; and 4) pain and discomfort have been addressed. A standardized discharge assessment scoring, such as, the modified Aldrete's score, and the modified post-anaesthesia discharge scoring system (mPADSS), were recommended. The mean recovery time required by both systems was reported to be 60 minutes, which is quite time-consuming. International guidelines on sedation in gastrointestinal endoscopy recommend a 1:1 nursing ratio to closely monitor patients following moderate or deep sedation to enhance patient safety. With this 1:1 ratio, recovery nurses can assess the consciousness level of patient every 10 minutes by standardized discharge assessment scoring, which facilitates a shorter recovery time. However, assessment every 10 minutes is time-consuming and labour-intensive and such recovery nursing ratio may not be practicable in resource-limited countries. In Hong Kong, the usual recovery nursing ratio is 1:10, therefore, the current standard practice is to assess patient's consciousness after 60 minutes. As a result, the number of endoscopies arranged in each session is limited by the recovery time (i.e. patient turnover rate), the recovery space and nursing manpower. Moreover, the decision of the recovery nurse on whether a patient is dischargeable can be interfered by a series of contextual factors, such as heavy workload, the availability of recovery space and the demand of patient. A fast, convenient, and reliable assessment system is warranted to reduce the recovery time (i.e. to increase the turnover rate) because of the anticipated increasing demand of sedated endoscopy which leads to the requirement for space and nursing manpower for patient recovery. To our best knowledge, no interventional trial has been conducted to reduce the recovery time by AI technology without increasing the nursing manpower. In the past decade, artificial intelligence (AI) technology has emerged and been successfully implemented in various clinical settings, particularly in the field of gastrointestinal endoscopy. AI models trained from endoscopic images have been proven to be effective in detecting and diagnosing gastrointestinal diseases and cancers. Human voice can be transferred to image and used to train AI models to assist in disease diagnosis. For example, AI has been trained to effectively detect Alzheimer's disease and predict its severity solely based on patients' voice data. Another AI model has been developed based on voice analysis to distinguish major psychiatric disorders, including bipolar, depressive, anxiety and schizophrenia spectrum disorders. Given these promising results, we have developed and validated an AI model to assess endoscopy recovery status based on 400 voice recordings from 200 patients. This model has a mean accuracy of 84.14% with a mean area under the curve (AUC) of 0.91. To further enhance the performance of this AI model, we plan to collect additional voice recordings to retrain it. We also plan to develop a mobile application of this AI model for effectiveness evaluation in a pilot randomized controlled trial (RCT) setting. Endoscopy nurses in Hong Kong were invited to participate in a survey study. Therefore, we believe implementation of AI model in clinical practice will be well accepted by endoscopy nurses in Hong Kong.1). Among the ten most common causes of cancer death worldwide, one third are digestive cancers. These can be diagnosed by outpatient gastrointestinal endoscopy. These include colorectal cancer (via colonoscopy), as well as esophageal and gastric cancer (via esophagogastroduodenoscopy). In addition to diagnosis, outpatient endoscopy is also widely used for cancer screening and surveillance. With the global increase in the aging population and heightened awareness of cancer screening, the demand for endoscopy services for cancer screening, diagnosis and surveillance is rapidly increasing to achieve the goal of early cancer detection and treatment. To reduce patients' fear and anxiety regarding endoscopy and to relieve the associated pain and discomfort, most endoscopies are performed under sedation. It is known that the sedative effect lasts longer than needed for diagnostic or basic therapeutic colonoscopies, which can mostly be done within 30 minutes. Patients are closely monitored at the recovery room after the completion of the endoscopy, and the recovery nurse assesses the consciousness of the patient after a fixed period of time, typically 60 minutes, or every 10 minutes until the standardized discharge criteria are met. In an outpatient setting, it is important to determine if patients are fully recovered from the sedative effect and have reached a clinically stable state before discharging them from the hospital with the accompany of a responsible adult. The assessment of the standardized discharge criteria includes the followings: 1) return of consciousness to baseline level; 2) vital signs are within normal limits; 3) respiratory status is not compromised; and 4) pain and discomfort have been addressed (10). A standardized discharge assessment scoring, such as, the modified Aldrete's score, and the modified post-anaesthesia discharge scoring system (mPADSS), were recommended. The mean recovery time required by both systems was reported to be 60 minutes, which is quite time-consuming. International guidelines on sedation in gastrointestinal endoscopy recommend a 1:1 nursing ratio to closely monitor patients following moderate or deep sedation to enhance patient safety. With this 1:1 ratio, recovery nurses can assess the consciousness level of patient every 10 minutes by standardized discharge assessment scoring, which facilitates a shorter recovery time. However, assessment every 10 minutes is time-consuming and labour-intensive and such recovery nursing ratio may not be practicable in resource-limited countries. In Hong Kong, the usual recovery nursing ratio is 1:10, therefore, the current standard practice is to assess patient's consciousness after 60 minutes. As a result, the number of endoscopies arranged in each session is limited by the recovery time (i.e. patient turnover rate), the recovery space and nursing manpower. Moreover, the decision of the recovery nurse on whether a patient is dischargeable can be interfered by a series of contextual factors, such as heavy workload, the availability of recovery space and the demand of patient. A fast, convenient, and reliable assessment system is warranted to reduce the recovery time (i.e. to increase the turnover rate) because of the anticipated increasing demand of sedated endoscopy which leads to the requirement for space and nursing manpower for patient recovery. To our best knowledge, no interventional trial has been conducted to reduce the recovery time by AI technology without increasing the nursing manpower. In the past decade, artificial intelligence (AI) technology has emerged and been successfully implemented in various clinical settings, particularly in the field of gastrointestinal endoscopy. AI models trained from endoscopic images have been proven to be effective in detecting and diagnosing gastrointestinal diseases and cancers. Human voice can be transferred to image and used to train AI models to assist in disease diagnosis. For example, AI has been trained to effectively detect Alzheimer's disease and predict its severity solely based on patients' voice data. Another AI model has been developed based on voice analysis to distinguish major psychiatric disorders, including bipolar, depressive, anxiety and schizophrenia spectrum disorders.

Being tested
AI-assisted endoscopy recovery assessment
Keywords
Artificial intelligence, endoscopy recovery, gastrointestinal, randomized controlled trial, colonoscopy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AI-assisted endoscopy recovery assessmentOther

    The intervention group will be assessed by the AI model regularly, which will be installed in a smartphone attached to the head of the stretcher once the patient in this group arrives at the recovery room. After the recovery nurse starts the AI application following the standard-of-care baseline assessment of vital signs, the AI application will prompt an automatic voice alarm to wake up the patient by asking if he/she is awake every 10 minutes.

Study groups in NCT06923059
Study groupRoleWhat they receive
AI-assisted endoscopy recovery assessment (AI) armExperimentalThe patients randomized to the AI arm will be assessed by the AI model regularly. A smartphone, with the mobile application of the AI model to assess for endoscopy recovery installed, will be attached to the head of the stretcher once the patient arrives at the recovery room. After the recovery nurse starts the AI application following the standard-of-care baseline assessment of vital signs, the AI application will prompt an automatic voice alarm to wake up the patient by asking if he/she is awake every 10 minutes. If the patient swipes the confirmation button, the AI application will ask them to read from 1 to 7. The patient's voice will be recorded and analyzed by the AI model. The assessment results of endoscopy recovery status will be uploaded to the cloud server and notify the recovery nurse. The recovery nurse will provide an early assessment of recovery if the AI analysis result suggests the patient is "conscious" before the pre-specified time point of standard-of-care.
Receives: Other: AI-assisted endoscopy recovery assessment
Standard-of-care (SC) armNo interventionThe recovery nurse will perform baseline assessments of vital signs every 10 minutes once the patient arrives at the recovery room, and a smartphone will be attached to the head of the stretcher, which will prompt an automatic voice alarm to wake up the patient by asking if he/she is awake every 10 minutes. If the patient swipes the confirmation button, they will be asked to read from 1 to 7. The patient's voice will be recorded but without AI analysis. The recovery nurse will assess the consciousness of the patient by mPADSS at a pre-specified time point: 1) after 60 minutes; 2) on demand of patient; 3) by nurse's judgement; or 4) in shortage of recovery space. After the subjects have fully recovered from sedation and are able to perform the 100-7 subtraction test correctly for 3 times, they will be asked to rate their satisfaction in terms of bedside manner, endoscopy technique, level of explanation and overall experience, time of stay and the care provided at the recovery room.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recovery time

    Differences between the time of arrival at the recovery room and the time of discharge

    Measured: Periprocedural

Secondary outcomes (5)
  1. Proportion of early discharge

    Recovery time less than 60 minutes will be reported as early discharge, and the proportion will be recorded

    Measured: Periprocedural

  2. Manpower usage

    A research assistant will record the patient contact time by the recovery nurse to calculate the manpower

    Measured: Periprocedural

  3. Patient's satisfaction

    Patient's perceived satisfaction in terms of time of stay and the care provided at the recovery room will be assessed after he/she is fully recover from sedation

    Measured: Periprocedural

  4. Patient's enrollment rate

    Number of participations divided by the total number of patients asked for consent

    Measured: Periprocedural

  5. Post-endoscopy adverse event rate

    Post-endoscopy adverse events, including haemoptysis, abdominal pain, and per rectal bleeding, and their rates at discharge and within 7 days will be recorded

    Measured: Periprocedural

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Apr 2025
  2. Study start1 Apr 2025 (estimated)
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion30 Jun 2027 (estimated)

Resources

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
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Model description
Patients will be randomized to either the AI-assisted endoscopy recovery assessment (AI) or standard-of-care (SC) arm in a 1:1 allocation ratio.
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
460 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06923059
Sponsor's protocol ID
2024.637
Acronym
AIVR2
Status last verified
Apr 2025
First submitted
25 Mar 2025
Last updated
11 Apr 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: There will be no plan to share Individual participant data

Questions about this trial

What is this clinical trial studying?

A study testing AI-assisted endoscopy recovery assessment in people with Artificial Intelligence Assistance in Endoscopy Recovery and AI Validation, run by Chinese University of Hong Kong at 1 site in Hong Kong.

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 3 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: opening soon, as of the sponsor's last update on 11 Apr 2025. 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 Hong Kong. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Felix SIA (852-26370428, felixsia@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recovery time (time frame: Periprocedural). 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 11 Apr 2025.

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