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Recruitment too complicated during pandemics. Phase 2 of recruitment completed and enough data available.
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| Name | Class |
|---|---|
| Erasme University Hospital | OTHER |
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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Digital Sedation | Experimental | Digital Sedation with rescue intravenous sedation (propofol) if needed upon patient request |
|
| Intravenous sedation | Active Comparator | Control arm with conventional Intravenous sedation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aqua© 30 on Oncomfort SedakitTM | Device | 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 |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Blero, Prof. MD. | Erasme University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Erasme | Brussels | 1070 | Belgium |
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| ID | Term |
|---|---|
| D015742 | Propofol |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| Propofol | Drug | 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. |
|
| 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 |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |