Clinical trial NCT05285098: Leipzig FAST-TRACK Over 15 Years for Cardiac Surgical Patients
Official title: Retrospective Analysis of 15 Years of Leipzig "Fast-Track" Concept.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Post-cardiac Surgery
Keywords: Fast track after cardiac surgery
ERAS cardiac surgery
Lead sponsor: Heart Center Leipzig - University Hospital
Sponsor class: OTHER
First posted: 2022-03-17
Enrollment: 20000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: -All consecutive cardiac surgical patients treatet with Leipzig fast-track protocol

Brief summary: Since November 2005, we are running a specialized post anesthetic care unit (PACU) in our tertiary, university affiliated high-volume heart centre. In our concept, we are bypassing ICU admission completely. The fast-track concept was initially applied to pre-selected elective patients undergoing low-risk operations. However, promising outcomes led to a more widespread utilization with more complex procedures. The aim of this study is to analyse the fast track evolutions.

Detailed description: Fast Track Treatment includes many elements recommended by the ERAS Society for cardiac surgery(1). Since November 2005, we are running a specialized post anesthetic care unit (PACU) in our tertiary, university affiliated high-volume heart centre. In our concept, we are bypassing ICU admission completely. The patients are transferred from the operation room to the recovery room, extubated there within a short time, stabilized and transferred on the same day to intermediate care (IMC). Ideally, the patient will be transferred to the normal ward on the first postoperative day. The fast-track concept was initially applied to pre-selected elective patients undergoing low-risk operations. However, promising outcomes led to a more widespread utilization with more complex procedures. The aim of this study is to analyse the evolutions within the fast-track protocol over a period of 15 years (from November 2005 to December 2020).

Eligibility criteria: Inclusion Criteria:

* Adults \>18y

Exclusion Criteria:

* Incomplete data
* Catheter-valve implantation

Primary outcomes:
measure: FT evolution analysis in complexity
timeFrame: Novmber 2005- December 2020
measure: FT evolution analysis in length of stay
timeFrame: Novmber 2005- December 2020
measure: FT evolution analysis in postoperative complications
timeFrame: Novmber 2005- December 2020
measure: FT evolution analysis in postoperative mortality rate
timeFrame: Novmber 2005- December 2020
Secondary outcomes:
Other outcomes:
Locations:
city: Leipzig
country: Germany
facility: Leipzig Heart center
state: Sachsen
Study officials:
affiliation: Leipzig Heart center
name: Joerg Ender
role: STUDY_CHAIR
References:
citation: Ender J, Borger MA, Scholz M, Funkat AK, Anwar N, Sommer M, Mohr FW, Fassl J. Cardiac surgery fast-track treatment in a postanesthetic care unit: six-month results of the Leipzig fast-track concept. Anesthesiology. 2008 Jul;109(1):61-6. doi: 10.1097/ALN.0b013e31817881b3.
citation: Engelman DT, Ben Ali W, Williams JB, Perrault LP, Reddy VS, Arora RC, Roselli EE, Khoynezhad A, Gerdisch M, Levy JH, Lobdell K, Fletcher N, Kirsch M, Nelson G, Engelman RM, Gregory AJ, Boyle EM. Guidelines for Perioperative Care in Cardiac Surgery: Enhanced Recovery After Surgery Society Recommendations. JAMA Surg. 2019 Aug 1;154(8):755-766. doi: 10.1001/jamasurg.2019.1153.
citation: Wong WT, Lai VK, Chee YE, Lee A. Fast-track cardiac care for adult cardiac surgical patients. Cochrane Database Syst Rev. 2016 Sep 12;9(9):CD003587. doi: 10.1002/14651858.CD003587.pub3.