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Recruiting

NCT Number: NCT06765538

Video Versus Face-to-face Preoperative Anaesthetic Assessment

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

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rigshospitalet

Copenhagen, Region Sjælland, 2200, Denmark

Location status: Recruiting

Location contact

Katrine B Buggeskov, M.D. PhD

CONTACT

[email protected]

004551921299

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Video consultation

Other

Preanaesthetic videoconsultation

Primary outcomes

  1. SAE

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Katrine Bredahl Buggeskov, Doctor

CONTACT

[email protected]

+45 51921299

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Official study title

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

Acronym: VIDFACE

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jan 9, 2025
Registry last updated
Feb 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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