Our primary study objective is whether visualizing and scoring of emboli is technically feasible. Secondary we want to asses the occurence and incidence of embolic events during spinal instrumentation surgery by intraoperative monitoring with TEE.…
ID
Source
Brief title
Condition
- Musculoskeletal and connective tissue deformities (incl intervertebral disc disorders)
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Incidence and severity of embolic processes during spinal surgery, measured
using transoesophageale echocardiography.
Secondary outcome
- Cardiopulmonary function (SO2, PO2, pCO2, etc.)
- Blood pressure (systolic, diastolic and mean arterial blood pressure)
Background summary
Sudden perioperative cardiopulmonary dysfunction caused by emboli is a known
complication of bone and joint surgery. Fat-and bone marrow emboli occur
frequently during drilling into intramedullary canals of long bones, as happens
during fixation of fractures or joint replacement surgery. These emboli are for
orthopedic surgeons and anesthesiologists a real concern because they can lead
to serious perioperative complications and are potentially fatal.
It is unknown whether embolism during spinal surgery resulting from the
insertion of instrumentation (pediclesrews) have a similar deleterious effect
on cardiopulmonary function. The incidence of (sub)clinical embolic processes
during surgery on the spine remains a topic of discussion.
Study objective
Our primary study objective is whether visualizing and scoring of emboli is
technically feasible. Secondary we want to asses the occurence and incidence of
embolic events during spinal instrumentation surgery by intraoperative
monitoring with TEE. In addition we want to evaluate the effect of
intraoperative embolism on cardiopulmonary function.
Study design
Observational feasibility study conducted in the University Medical Center
Utrecht.
Study burden and risks
The use of TEE is considered as non-invasive, especially in patients under
anesthesia. Complications are rare, a 0-0,5% complication rate is reported in a
study of 7200 patients who underwent TEE. Most of these complications are
related to insertion of the ultrasound probe in the esophagus. Extreme caution
when inserting the probe will even minimize potential complications.
Postbus 85500
3508GA Utrecht
NL
Postbus 85500
3508GA Utrecht
NL
Listed location countries
Age
Inclusion criteria
Adult patients undergoing elective spinal surgery where the use of pedicle screws and/or vertebroplasty is planned.
Exclusion criteria
A contra-indication for the use of transoesophageal echocardiography: oropharyngeal carcinoma, esophageal varices, esophageal stricture, esophageal diverticulum, esophagitis, Mallory-Weiss tear, recent upper gastro-intestinal hemorrhage, gastric ulcer, symptomatic hiatal hernia.
Indication for acute surgery: traumatic injury, metastatic fracture
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 | NL30307.041.10 |