Digital Sedation: Virtual Reality Hypnosis During Colonoscopy (COLDiS)

A Prospective Randomized Controlled Monocentric Study Comparing Digital Sedation Versus Intravenous Sedation Among Patients Undergoing Colonoscopy

This prospective Randomized Controlled Trial will evaluate efficacy, safety, and pharmacoeconomic outcomes in patients undergoing colonoscopy with either Digital Sedation using the Aqua© module of the Oncomfort device (Sedakit TM) or the standard of care, intravenous sedation with propofol. The Aqua© module is designed for sedation and management of pain and anxiety related to medical and surgical procedures.

Study Overview

• Status: Terminated
• Conditions: Colonoscopy
• Intervention / Treatment: Device: Aqua© 30 on Oncomfort SedakitTM; Drug: Propofol

Detailed Description

This prospective Randomized Controlled Trial will evaluate efficacy, safety, and pharmacoeconomic outcomes in patients undergoing colonoscopy with either Digital Sedation using the Aqua© module of the Oncomfort device (Sedakit TM) or the standard of care, intravenous sedation with propofol. The Aqua© module is designed for sedation and management of pain and anxiety related to medical and surgical procedures.

Participants will be recruited during the anesthesiology consultation conducted in preparation for colonoscopy. Those with indication for screening or diagnostic colonoscopy under conventional intravenous sedation (propofol) and willing to participate will provide their written informed consent and will be randomized (2:1) between two arms:

1. Experimental arm: Digital Sedation, with rescue intravenous sedation (propofol) if needed upon patient request
2. Control arm: conventional intravenous sedation (propofol)

The study will be divided into three stages, with randomization (2:1) maintained throughout. In the first stage, accrual will be halted when about 45 patients have been randomized, at least 27 of whom being evaluable patients randomized to the experimental arm. A non-binding futility analysis is planned for the primary outcome. In the second stage, accrual will be halted when about 90 patients have been randomized. A non-binding futility analysis is planned for the primary outcome. If the milestones are met, accrual will be reopened to the second stage and the study will continue to the planned final accrual of 177 patients (118 to experimental and 59 to control arm, respectively). At the end of the recruitment of Stage 1 and 2, an analysis of the secondary outcomes will also be run. Results of these analysis could also impact the decision for pursuing to second/ third stage.

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 1070
    • Hopital Erasme

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age of 18 years or older
• Indication for screening or diagnostic colonoscopy under conventional IVS (propofol)
• Provision of written informed consent

Exclusion Criteria:

• Scheduled dilation
• Active Crohn Disease
• Low auditory acuity that precludes use of the device
• Low visual acuity that precludes use of the device
• Head or face wounds precluding use of the device
• Schizophrenia
• Dizziness
• Water/sea phobia
• Non-proficiency in French or Dutch (research language)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Digital Sedation; Digital Sedation with rescue intravenous sedation (propofol) if needed upon patient request	Device: Aqua© 30 on Oncomfort SedakitTM; Digital Sedation session consists in a virtual reality software (Aqua© 30 Version 3.0, Oncomfort SA, Waver, Belgium) including a clinical hypnosis script.Patients in the intervention group will undergo a 30-minute Digital Sedation program through a VR headset and headphones. This medical device called Oncomfort SedakitTM has been created to reduce anxiety and pain during medical/ surgical interventions; Drug: Propofol; Standard sedation starting doses of 1 µg/ml to 6 µg/ml depending on patient's reaction and titrated incrementally by 0.5µg/ml. Doses are adapted according to the level of comfort and needs of the patient.
Active Comparator: Intravenous sedation; Control arm with conventional Intravenous sedation	Drug: Propofol; Standard sedation starting doses of 1 µg/ml to 6 µg/ml depending on patient's reaction and titrated incrementally by 0.5µg/ml. Doses are adapted according to the level of comfort and needs of the patient.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To confirm the feasibility of using digital sedation in colonoscopy (stage 1)	cecal intubation rate, rate of rescue sedation	Day 1
To demonstrate adequate performance of colonoscopy using digital sedation (stage 2)	cecal intubation rate, rate of rescue sedation	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To compare patient experience in both arms	Measure of satisfaction by Likert scale (0 to 5), pain by Visual Analogue Scale (VAS 0 to 10), anxiety by Visual Analogue Scale (VAS 0 to 10), comfort by Visual Analogue Scale (VAS 0 to 10), Preferred type of sedation, Recall of the procedure, Experienced side effects/ AE	Day 1 & Day 2 Follow-up call
To compare measures of colonoscopy performance in both arms	Compare Cecal intubation rates, Adenoma detection rates, Withdrawal time,Total duration of colonoscopy, Total duration of sedation,Total length of stay in procedure room,Total length of stay in recovery room,Total length of stay in hospital	Day 1
To assess the need for rescue sedation in the experimental arm	Proportion of patients with cecal intubation without rescue sedation in the experimental arm, Frequency of use of intravenous sedation (propofol) and of complete interruption of digital sedation	Day 1
To compare use of sedation medication in both arms	Average (per patient) total doses of sedation medication per arm	Day 1
To assess gastroenterologist and anesthesiologist satisfaction in both arms	Measure of satisfaction by Likert scale (0 to 5) and of perceived facilitation or impediment of the procedure by Digital Sedation as measured by Likert scale (0 to 5)	Day 1
To assess gastroenterologist and anesthesiologist stress in both arms	Measure of stress by Visual Analogue Scale (VAS 0 to 10)	Day 1
To compare physiologic measures in both arms	Oxygen saturation (minimal observed during procedure), MBP (min/max.), Heart rate (min/max)	Day 1
To assess difficulty or ease of the procedure in both arms	Number of abdominal manipulations and patient mobilizations	Day 1
To compare the safety in both arms	Frequency and type of AEs and SAEs, Frequency and severity of episodes of desaturation and of HR/ MBP changes	Screening, Day 1 & Day 2 Follow-up call

Collaborators and Investigators

• Sponsor: Oncomfort
• Collaborators: Erasme University Hospital
• Investigators: Principal Investigator: Daniel Blero, Prof. MD., Hopital Erasme

Study record dates

Study Major Dates

• Study Start (Actual): June 25, 2020
• Primary Completion (Actual): September 20, 2021
• Study Completion (Actual): December 21, 2021

Study Registration Dates

• First Submitted: July 6, 2020
• First Submitted That Met QC Criteria: July 6, 2020
• First Posted (Actual): July 10, 2020

Study Record Updates

• Last Update Posted (Actual): October 3, 2022
• Last Update Submitted That Met QC Criteria: September 29, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Hypnotics and Sedatives; Propofol
• Other Study ID Numbers: OC08

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No