Comparing video and in-person preoperative anaesthetic assessments
Video Versus Face-to-face Preoperative Anaesthetic Assessment: a Randomized Clinical Trial on Safety and User Satisfaction
This study is testing whether video-based preoperative anaesthetic assessments are as safe and effective as in-person consultations for patients having ear, nose, throat, or dental surgeries.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 2260 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Rigshospitalet, Denmark Academic / other |
| Locations | 1 site (Copenhagen, Region Sjælland) |
| Trial ID | NCT06765538 on ClinicalTrials.gov |
What this trial studies
This clinical trial compares the effectiveness of video-based preoperative anaesthetic assessments to traditional face-to-face consultations for patients undergoing elective Ear-Nose-Throat or Tooth-Mouth-Jaw surgery. The study will enroll 2260 participants and will randomize them into two groups to evaluate patient safety, satisfaction, and potential economic benefits. The primary outcome will focus on the incidence of serious adverse events, while secondary outcomes will assess changes in anaesthesia plans and delays or cancellations on the day of surgery. Data will be analyzed by blinded statisticians to ensure objectivity in the results.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years undergoing elective ENT or TMJ surgery who can utilize video technology.
Not a fit: Patients with severe mental challenges or those deemed unsuitable for video technology will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance patient access to preoperative assessments while maintaining safety and satisfaction.
How similar studies have performed: Other studies have shown promising results with telemedicine approaches in preoperative assessments, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * ENT and TMJ patients * Adults \> 18 years * Informed consent obtained after a consideration period of minimum 24 hours Exclusion Criteria: * If a patient is assessed unsuitable for the video technology in example, patients with severe mental challenges (dementia, retardation, etc.), they will not be included in the trial. If excluded, the patient receives standard care, face-to-face preoperative anaesthetic assessment. * Local protocol screen patients
Where this trial is running
Copenhagen, Region Sjælland
- Rigshospitalet — Copenhagen, Region Sjælland, Denmark (Recruiting)
Study contacts
- Study coordinator: Katrine Bredahl Buggeskov, Doctor
- Email: katrine.bredahl.buggeskov@regionh.dk
- Phone: +45 51921299
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.