Clinical Trials Directory

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RecruitingNCT06765538

Video Versus Face-to-face Preoperative Anaesthetic Assessment

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

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
2,260 (estimated)
Sponsor
Rigshospitalet, Denmark · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERVideo consultationPreanaesthetic videoconsultation

Timeline

Start date
2024-11-04
Primary completion
2026-04-30
Completion
2026-11-30
First posted
2025-01-09
Last updated
2025-02-03

Locations

1 site across 1 country: Denmark

Source: ClinicalTrials.gov record NCT06765538. Inclusion in this directory is not an endorsement.