To assess the incidence and severity of embolic events during spinal instrumentation surgery with intraoperative transesophageal echocardiography monitoring.
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
a) The incidence and extent of echogenic material visualized with
intraoperative transesophageal echocardiography
b) Intraoperative cardiopulmonary function
Secondary outcome
Age, gender, Body mass index (BMI), history of deep venous thrombosis or
pulmonary embolism, preoperative physical status (ASA- class), history of
smoking, co-morbidity of osteoporosis, diabetes, paralysis of lower
extremities, bleeding disorder, (antithrombotic) medication, previous estrogen
therapy
Type of surgical procedure, level and number of fusion of vertebral bodies,
number of instrumentations placed, operative time, blood loss, units of red
blood cells transfused, clinical embolic events after surgery, other surgical
complications, and mortality.
Background summary
Sudden intraoperative or perioperative cardiopulmonary dysfunction as a result
of embolism is a well-known complication of bone and joint surgery. Fat and
bone-marrow emboli are frequently produced during the pressurization and
manipulation of the intramedullary canals of long bones during *xation of
fractures or joint replacement surgery. They are a serious concern among
orthopaedic surgeons and anesthesiologists as they can lead to severe clinical
as well as subclinical perioperative complications and are potentially fatal.
Before introducing the screw, the pedicle, that anatomically resembles a
tubular bone with an intramedullary canal, is prepared with a blunt probe,
similar to the introduction of a joint prosthesis or intramedullary nail. Also,
in the treatment of traumatic or pathologic fractures, bone cement is
introduced into the cancellous bone of the vertebral body which may also lead
to thrombo-embolic events.
Spinal instrumentation surgery is advancing and the use of pedicle screws is
increasing worldwide but occurrence and incidence of (subclinical) embolic
events during spinal procedures remain a matter of debate.
Study objective
To assess the incidence and severity of embolic events during spinal
instrumentation surgery with intraoperative transesophageal echocardiography
monitoring.
Study design
Observational study performed at the University Medical Center Utrecht.
Study burden and risks
The use of transoesophageal echocardiography is considered to be non-invasive,
especially when patients are under general anesthesia. TEE-associated
complications are a rarity; a 0%-0.5% complication rate has been reported in a
study of 7200 patients undergoing TEE (Kallmeyer, 2000) Most of these
complications are related to the insertion of the echo probe in the esophagus;
odynophagia occurred in 0.1% of patients, swallowing abnormality in 0.01%,
esophageal abrasion in 0.06%, upper gastrointestinal hemorrhage in 0.03%,
esophageal perforation in 0.01% and dental injury in 0.03%. The benefits are:
gaining more knowledge about incidence and direct consequences of
intraoperative embolism on cardiopulmonary function.
Postbus 85500
3508GA Utrecht
Nederland
Postbus 85500
3508GA Utrecht
Nederland
Listed location countries
Age
Inclusion criteria
Patients where spinal instrumentation surgery is indicated.
Exclusion criteria
Multi-trauma patients and contra-indications for the use of transesophageal echocardiography: oropharyngeal carcinoma, oesophageal varices, oesophageal stricture, oesophageal diverticulum, oesophagitis, Mallory-Weiss tear, recent upper gastro-intestinal hemorrhage, gastric ulcer, symptomatic hiatal hernia.
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 | NL24729.041.08 |