Optimalisation proning procedure and prone positioning in the operating room using the Inflatable Board and Inflatable Prone Support.

Completed

• Conditions: prone; spine surgery; 10005944

• Registration Number: NL-OMON48353
• Lead Sponsor: Ergotrics NV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 2018-12-20
• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 5

Inclusion Criteria

From 18 years of age
Male
Scheduled to undergo non-instrumented lumbar spine surgery in prone position
Signed Informed Consent Form

Exclusion Criteria

Known sensitivity to polyvinylchloride or polyamide
Overweight patient (> 150 kg)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Evaluation stability prone position (by surgeon)<br /><br>Evaluation proning and positioning by anesthesiologist<br /><br>Evaluation prone position by anesthesiologist<br /><br>Evaluation ergonomic and hygienic features by medical staff<br /><br>Evaluation of usability<br /><br>Evaluation required number of staff members<br /><br>Time required for proning / time in prone position<br /><br>Peri-operative adverse events</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>none</p><br>