Video Versus Face-to-face Preoperative Anaesthetic Assessment

NCT ID: NCT06765538

Last Updated: 2025-02-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

2260 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-04

Study Completion Date

2026-11-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Anesthesia Telemedicine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Video consultation

Patients receiving video consultations

Group Type EXPERIMENTAL

Video consultation

Intervention Type OTHER

Preanaesthetic videoconsultation

Physical consultation

Patients receiving physical consultations (standard care)

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Video consultation

Preanaesthetic videoconsultation

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rigshospitalet, Denmark

OTHER

Sponsor Role lead

Responsible Party

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Katrine Bredahl Buggeskov

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Rigshospitalet

Copenhagen, Region Sjælland, Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Katrine Bredahl Buggeskov, Doctor

Role: CONTACT

+45 51921299

Facility Contacts

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Katrine B Buggeskov, M.D. PhD

Role: primary

004551921299

References

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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.

Reference Type DERIVED
PMID: 40467292 (View on PubMed)

Other Identifiers

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H-24006615

Identifier Type: -

Identifier Source: org_study_id

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