Virtual Reality Assisted Conscious Sedation During TAVI (TAVI_VR)

Virtual Reality Assisted Conscious Sedation During Transcatheter Aortic Valve Implantation - a Randomized Pilot Study

Transcatheter aortic valve implantation (TAVI) is an established therapy for patients with severe aortic valve stenosis. Pain and anxiety are major contributors to procedural complications. Virtual Reality (VR) glasses have already been used successfully in different clinical settings to treat anxiety and delirium. The aim of this prospective, randomized investigation is to prove the feasibility and safety of VR interventions in patients undergoing conscious sedation during TAVI with local anesthesia only.

Study Overview

• Status: Completed
• Conditions: Pain; Anxiety; Severe Aortic Valve Stenosis
• Intervention / Treatment: Other: VR during TAVI

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Duesseldorf, Germany, 40225
    • Division of Cardiology, Pulmonary Disease and Vascular Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Interventional transfemoral TAVI
• Informed consent
• Normal or corrected vision (through glasses)

Exclusion Criteria:

• Patients whose communication is limited due to a language barrier
• Patients who could not watch the 3D video due to uncorrectable vision
• all patients with transapical TAVI were also excluded.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention	Other: VR during TAVI; Virtual Reality (VR) glasses
No Intervention: Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in anxiety	A visual analog scale will be used to determine the level of anxiety before and after the procedure. The visual analogue scale or visual analog scale (VAS) is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points (0=no anxiety, 10=maximum anxiety/extremly anxious)	at Baseline
Change in anxiety	A visual analog scale will be used to determine the level of anxiety before and after the procedure. The visual analogue scale or visual analog scale (VAS) is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points (0=no anxiety, 10=maximum anxiety/extremly anxious)	after 24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time of VR	The time [min] of VR use will be recorded during the procedure	at Baseline
Evaluation of clinical frailty scale	The Clinical Frailty Scale (CFS) is a simple model visually describing patients physical conditions with nine classes from very fit (class 1) to terminally ill (class 9).	at Baseline
Measurement of pain: visual analog scale	A visual analog scale will be used to determine the level of pain after the procedure. A visual analog scale will be used to determine the level of anxiety before and after the procedure. The visual analogue scale or visual analog scale (VAS) is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points (0=no pain, 10=unbearable pain)	after 24 hours
Length of stay at hospital	The length of stay at hospital will be recorded.	up to 5 days
Occurence of vomitting	Patients will be asked during and after the procedure for safety problems with special regards to vomiting	at Baseline, periprocedural and after 24 hours
Occurence of nausea	Patients will be asked during and after the procedure for safety problems with special regards to nausea	at Baseline, periprocedural and after 24 hours
Rate of Intra-hospital mortality	The intra-hospital mortality will be assessed after discharge	up to 5 days

Collaborators and Investigators

• Sponsor: Klinik für Kardiologie, Pneumologie und Angiologie

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2019
• Primary Completion (Actual): June 1, 2020
• Study Completion (Actual): June 1, 2020

Study Registration Dates

• First Submitted: January 29, 2020
• First Submitted That Met QC Criteria: February 5, 2020
• First Posted (Actual): February 6, 2020

Study Record Updates

• Last Update Posted (Actual): June 18, 2020
• Last Update Submitted That Met QC Criteria: June 18, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: TAVI; VR; 3D glasses
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis
• Other Study ID Numbers: 19-007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No