Interdisciplinary and cross-sectoral perioperative care model in cardiac surgery: implementation in the setting of minimally invasive heart valve surgery (INCREASE)-study protocol for a randomized controlled trial

TY - JOUR

T1 - Interdisciplinary and cross-sectoral perioperative care model in cardiac surgery: implementation in the setting of minimally invasive heart valve surgery (INCREASE)-study protocol for a randomized controlled trial

AU - Klotz, Susanne G R

AU - Ketels, Gesche

AU - Behrendt, Christian A

AU - König, Hans-Helmut

AU - Kohlmann, Sebastian

AU - Löwe, Bernd

AU - Petersen, Johannes

AU - Stock, Sina

AU - Vettorazzi, Eik

AU - Zapf, Antonia

AU - Zastrow, Inke

AU - Zöllner, Christian

AU - Reichenspurner, Hermann

AU - Girdauskas, Evaldas

N1 - © 2022. The Author(s).

PY - 2022/6/23

Y1 - 2022/6/23

N2 - BACKGROUND: Valvular heart diseases are frequent and increasing in prevalence. Minimally invasive heart valve surgery embedded in an interdisciplinary enhanced recovery after surgery (ERAS) program may have potential benefits with regard to reduced length of stay and improved patient reported outcomes. However, no prospective randomized data exist regarding the superiority of ERAS program for the patients' outcome.METHODS: We aim to randomize (1:1) a total of 186 eligible patients with minimally invasive heart valve surgery to an ERAS program vs. standard treatment at two centers including the University Medical Center Hamburg-Eppendorf, Germany, and the University Hospital Augsburg, Germany. The intervention is composed out of pre-, peri-, and postoperative components. The preoperative protocol aims at better preparation for the operation with regard to physical activity, nutrition, and psychological preparedness. Intraoperative anesthesiologic and surgical management are trimmed to enable an early extubation. Patients will be transferred to a specialized postoperative anesthesia care unit, where first mobilization occurs 3 h after surgery. Transfer to low care ward will be at the next day and discharge at the fifth day. Participants in the control group will receive treatment as usual. Primary endpoints include functional discharge at discharge and duration of in-hospital care during the first 12 months after index surgery. Secondary outcomes include health-related quality of life, health literacy, and level of physical activity.DISCUSSION: This is the first randomized controlled trial evaluating the effectiveness of an ERAS process after minimally invasive heart valve surgery. Interprofessional approach is the key factor of the ERAS process and includes in particular surgical, anesthesiological, physiotherapeutic, advanced nursing, and psychosocial components. A clinical implication guideline will be developed facilitating the adoption of ERAS model in other heart teams.TRIAL REGISTRATION: The study has been registered in ClinicalTrials.gov ( NCT04977362 assigned July 27, 2021).

AB - BACKGROUND: Valvular heart diseases are frequent and increasing in prevalence. Minimally invasive heart valve surgery embedded in an interdisciplinary enhanced recovery after surgery (ERAS) program may have potential benefits with regard to reduced length of stay and improved patient reported outcomes. However, no prospective randomized data exist regarding the superiority of ERAS program for the patients' outcome.METHODS: We aim to randomize (1:1) a total of 186 eligible patients with minimally invasive heart valve surgery to an ERAS program vs. standard treatment at two centers including the University Medical Center Hamburg-Eppendorf, Germany, and the University Hospital Augsburg, Germany. The intervention is composed out of pre-, peri-, and postoperative components. The preoperative protocol aims at better preparation for the operation with regard to physical activity, nutrition, and psychological preparedness. Intraoperative anesthesiologic and surgical management are trimmed to enable an early extubation. Patients will be transferred to a specialized postoperative anesthesia care unit, where first mobilization occurs 3 h after surgery. Transfer to low care ward will be at the next day and discharge at the fifth day. Participants in the control group will receive treatment as usual. Primary endpoints include functional discharge at discharge and duration of in-hospital care during the first 12 months after index surgery. Secondary outcomes include health-related quality of life, health literacy, and level of physical activity.DISCUSSION: This is the first randomized controlled trial evaluating the effectiveness of an ERAS process after minimally invasive heart valve surgery. Interprofessional approach is the key factor of the ERAS process and includes in particular surgical, anesthesiological, physiotherapeutic, advanced nursing, and psychosocial components. A clinical implication guideline will be developed facilitating the adoption of ERAS model in other heart teams.TRIAL REGISTRATION: The study has been registered in ClinicalTrials.gov ( NCT04977362 assigned July 27, 2021).

KW - Cardiac Surgical Procedures

KW - Heart Valves/surgery

KW - Humans

KW - Perioperative Care/methods

KW - Quality of Life

KW - Randomized Controlled Trials as Topic

KW - Treatment Outcome

U2 - 10.1186/s13063-022-06455-x

DO - 10.1186/s13063-022-06455-x

M3 - SCORING: Journal article

C2 - 35739541

VL - 23

JO - TRIALS

JF - TRIALS

SN - 1745-6215

IS - 1

M1 - 528

ER -