To obtain user and medical staff feed-back on the safety, clinical performance and ergonomic features of the IPS and IBO.
ID
Source
Brief title
Condition
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Evaluation stability prone position (by surgeon)
Evaluation proning and positioning by anesthesiologist
Evaluation prone position by anesthesiologist
Evaluation ergonomic and hygienic features by medical staff
Evaluation of usability
Evaluation required number of staff members
Time required for proning / time in prone position
Peri-operative adverse events
Secondary outcome
none
Background summary
The prone position has been used in a wide variety of operations since the
1930s. Currently the proning and positioning of the patient requires physical
power and puts an ergonomic burden on the medical staff. Ergotrics developed
products which allow for the optimal moving and positioning of patients in
prone position without the need for physical power. This is a user test.
Study objective
To obtain user and medical staff feed-back on the safety, clinical performance
and ergonomic features of the IPS and IBO.
Study design
single arm, single center user test
Intervention
proning using the IBO (Inflatable BOard)
positioning using the IPS (Inflatable Prone Support)
Study burden and risks
none
Bredaseweg 20
Hoogstraten 2322
BE
Bredaseweg 20
Hoogstraten 2322
BE
Listed location countries
Age
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)
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL68064.028.18 |