To assess the change in Intra-Abdominal Pressure (IAP), measured via indwelling urinary catheter, when using the IPS for positioning a subject in prone position for spine surgery.
ID
Source
Brief title
Condition
- Nervous system, skull and spine therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The change in Intra-Abdominal Pressure (IAP) caused by inflation of the IPS
(IAP before inflation versus IAP after inflation of the IPS) with the subject
under general anesthesia in prone position.
Secondary outcome
Change in IAP over time (supine before proning, prone before IPS inflation,
prone after IPS inflation, prone 45 minutes after IPS inflation, at end of
surgery and supine after regaining consciousness from anesthesia).
Impact of BMI on IAP change when using the IPS
Impact of body weight on IAP change when using the IPS
Impact of body morphology on IAP change when using the IPS
Impact of delta IAP (difference between the end-inspiratory and the
end-expiratory IAP) at baseline on IAP change.
Blood loss and correlation with IAP
Serious adverse events at 48 hours post procedure
Background summary
The prone position has been used to provide posterior surgical access in a wide
variety of operations since the 1930s. Whenever patient position is changed
from supine to prone, the Intra-Abdominal Pressure (IAP) increases due to
abdominal compression in the prone position. The rise in IAP can cause venous
congestion in the pelvis and abdomen. This may lead to backflow of venous blood
into the large valveless vertebral venous system, which can result in venous
congestion in the rigid spinal canal and increase bleeding which makes spinal
surgery complicated.
Spine surgeons are concerned about intraoperative bleeding during spinal
surgery because even minor bleeding can obstruct the surgeon*s field of vision
resulting in difficulties in microsurgical manipulation. In addition,
significant blood loss during spinal surgery is associated with unfavorable
surgical outcomes and prolonged hospital stays.
Therefore patients in prone position are positioned in a manner to offload the
abdomen (*free hanging*) as much as possible to avoid an increased IAP.
Different positioning tools exist such as the Wilson frame, pads, bolsters and
more recently the Inflatable Prone Support (IPS).
Study objective
To assess the change in Intra-Abdominal Pressure (IAP), measured via indwelling
urinary catheter, when using the IPS for positioning a subject in prone
position for spine surgery.
Study design
Prospective, observational, single-arm, monocenter study
Study burden and risks
No burden to the patient
The risks associated with the IPS are the same as those during use of the IPS
outside the study.
The risks associated with the transurethral bladder catheter are the same as
for subjects not participating in this study. Subjects undergoing a surgical
procedure often receive a transurethral bladder catheter per standard of care.
In this study only subjects with a transurethral bladder catheter in place are
enrolled. Therefore the risks related to the transurethral bladder catheter are
the same as for subjects not participating in this study.
The risk related to the IAP measurement is minimal. The external pressure
transducer is connected to a port of the transurethral bladder catheter. There
are no known risk related to the use of the external pressure transducer.
Slachthuisstraat 120 bus 8
Turnhout 2300
BE
Slachthuisstraat 120 bus 8
Turnhout 2300
BE
Listed location countries
Age
Inclusion criteria
Age 18-80 at time of surgery
Subject planned to undergo spine surgery in prone position
Subject planned to have transurethral bladder catheter during surgery
Body weight * 120kg
Exclusion criteria
Abdominal or urethral surgery during past 12 months.
Contraindication to use of transurethral bladder catheter
History of recent (<3 months) urinary tract or bladder infection.
Known allergy to IPS material
Current systemic infection or local infection
Current known pregnancy
Subject is participating in an investigational study
Coagulation Issues/disorders
Design
Recruitment
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 | NL72983.028.20 |