Does the introduction of routine postsurgical anesthesia visits reduce postoperative 30-day mortality?
ID
Source
Brief title
Condition
- Therapeutic procedures and supportive care NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
30-day postoperative mortality, including cost effectiveness research.
Secondary outcome
n.v.t.
Background summary
In the Netherlands, about 1.4 million undergo anesthesia and surgery on a
yearly base. The number of patients in a medium to high-risk population who
develop a complication after surgery is estimated at 30%. Postsurgical
mortality is mainly caused by the lack of a standardized follow-up of patients
who develop a postoperative complication, which results in failure to rescue.
The TRACE study aims to investigate whether standardized anesthesia visits on
day 1 and 3 following surgery reduces 30-day mortality by decreasing failure to
rescue rates.
Study objective
Does the introduction of routine postsurgical anesthesia visits reduce
postoperative 30-day mortality?
Study design
A nationwide, multicenter stepped-wedge design study in academic and peripheral
hospitals.
Intervention
Interventions: Postoperative visit by an anesthesia professional on day 1 and 3
following the surgical procedure. The postoperative visit will be standardized
based on the Modified Early Warning Score (MEWS) that estimates vital function.
Standard intervention to be compared to: No postoperative follow-up of patients
by an anesthesia professional.
Study burden and risks
Control group: Usual clinical care with 30-day and 12-month follow-up of
complications.
Intervention group: Standardized postoperative visit by an anesthesia
professional at day 1 and 3 following surgery, MEWS questionnaire, and 30-day
and 12-months follow-up of complications.
De Boelelaan 1117
Amsterdam 1081 HV
NL
De Boelelaan 1117
Amsterdam 1081 HV
NL
Listed location countries
Age
Inclusion criteria
* Adult patients undergoing elective surgery with an indication for postoperative hospital stay
* Meets at least one of the following BonnScore criteria:
o Postoperative pain therapy with follow up by an Acute Pain Service (APS)
o Patients older than 60 years
o Patients older than 45 years and a rCRI greater than 2
o Patients with a sAPGAR smaller than 5
rCRI: The revised Cardiac Risk Index (rCRI) is a clinical prediction tool to estimate the risk of a patient for perioperative cardiac complications. The risk is determined based on the presence of ischemic heart disease, congestive heart failure, cerebrovascular disease (stroke or transient ischemic attack), diabetes requiring preoperative insulin use, chronic kidney disease (creatinine > 2 mg/dL), and/or undergoing suprainguinal vascular, intraperitoneal, or intrathoracic surgery. The risk for cardiac death, nonfatal myocardial infarction, and nonfatal cardiac arrest is 0.4% in case of 0 predictors, 0.9% in case of 1 predictor, 6.6% in case of 2 predictors and 11% in case of 3 or more predictors.
Surgical APGAR score: The surgical APGAR score is used to predict perioperative and postoperative morbidity and mortality based on predicted perioperative blood loss, intraoperative blood pressure and intraoperative heart rate. The score is calculated at the end of a surgical procedure.
Exclusion criteria
* Cardiac surgery
* Preoperative indication for medium care or intensive care admission
* No informed consent
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 | NL56004.029.16 |