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Recruiting NCT06765538

Video Versus Face-to-face Preoperative Anaesthetic Assessment

No phase Interventional Anesthesia Telemedicine

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Video consultation.
Who it may be relevant to
Registry conditions: Anesthesia, Telemedicine. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Denmark
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Video Versus Face-to-face Preoperative Anaesthetic Assessment: a Randomized Clinical Trial on Safety and User Satisfaction

Overview

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.

Interventions

  • Other Video consultation
    Preanaesthetic videoconsultation

Primary outcome measures

  • SAE [Time frame: 30 day follow up]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Other

Study locations

Denmark · 1 center
  • Rigshospitalet — Copenhagen

Publications

  • Bosholdt SA, Denneborg MKG, Rosenkrantz O, Moller MH, Jakobsen JC, Olsen MH, Mogelmose A, Hesselfeldt RT, Buggeskov KB. Video Versus Face-To-Face Preoperative Anaesthetic Assessment: The VIDFACE Trial-A Statistical Analysis Plan. Acta Anaesthesiol Scand. 2025 Jul;69(6):e70068. doi: 10.1111/aas.70068. PMID 40467292

Identifiers

NCT: NCT06765538 · H-24006615

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗