Video Versus Face-to-face Preoperative Anaesthetic Assessment

Not Applicable

Recruiting

• Conditions: Anesthesia; Telemedicine

• Registration Number: NCT06765538
• Lead Sponsor: Rigshospitalet, Denmark

Brief Summary

Randomized clinical trial rewieving difference between anaesthetic preassessment in physical consultations vs. video consultations.

Detailed Description

Preoperative anaesthetic assessment aims to reduce morbidity and mortality and are currently accepted as the gold standard of care for elective surgery. Technical advances in society have led to explora-tions within the telemedicine area which continues providing safe and effective services. The video versus face-to-face preoperative anaesthetic assessment (VIDFACE) trial aims to compare videobased preoperative anaesthetic assessment to standard face-to-face consultations with focus on patient safety and satisfaction including possible beneficial eco and economical effects compared to standard face-to-face consultations.

This is a randomised, single-centre, two-arm, assessor, and data analyst blinded clinical trial. We will enrol 2260 participants undergoing elective Ear-Nose-Throat or Tooth-Mouth-Jaw surgery. Participants will be randomised 1:1 stratified by malignant versus benign surgery to either video based preoperative anaesthetic assessment or face-to-face consultation. Data will be analysed by two blinded statisticians, and we will write abstracts covering all possible combinations of conclusions, before breaking the blind.

Results:

The primary outcome is the incidence of six predefined serious adverse events (SAE). Secondary outcomes are the proportion of participant with a change in anaesthesia plan as well as delays or cancellations on the day of surgery and patient satisfaction.

The VIDFACE trial will contribute valuable knowledge on the efficacy and safety on using video consultations in the an-aesthetic preoperative assessment.

Study Timeline

• Study Start: 2024-11-04
• Status Verified: 2025-01
• Study First Submitted: 2025-01-03
• Study First Submitted QC: 2025-01-03
• Study First Posted: 2025-01-09
• Last Update Submitted: 2025-01-30
• Last Update Posted: 2025-02-03
• Primary Completion: 2026-04-30
• Study Completion: 2026-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2260

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
SAE	30 day follow up	All-cause mortality, all-cause admission to intensive care unit, bleeding requiring transfusion, infection requiring antibiotics, hospital readmission or prolonged hospitalization.

Trial Locations

Locations (1)

Rigshospitalet; 🇩🇰 Copenhagen, Zealand, Denmark