Viewing Study NCT03956420


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Study NCT ID: NCT03956420
Status: UNKNOWN
Last Update Posted: 2019-05-20
First Post: 2019-05-14
Is NOT Gene Therapy: False
Has Adverse Events: False

Brief Title: Enhanced Recovery After Surgery (ERAS) in Coronary Artery Bypass Graft / Off Pump Coronary Artery Bypass (CABG/OPCAB)
Sponsor: Silesian University of Medicine
Organization:

Study Overview

Official Title: ERAS Implementation in Coronary Artery Bypass Surgery
Status: UNKNOWN
Status Verified Date: 2019-05
Last Known Status: ENROLLING_BY_INVITATION
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: It has been assumed that some elements of the ERAS protocol may contribute to the reduction of complications and improve the satisfaction of patients undergoing coronary artery bypass surgery.

Elements of the ERAS strategy will be tested in this study. The elements that prove to be feasible and have a positive effect on the treatment process will be introduced into everyday clinical practice.

In the next stage of the research, we are planning to investigate whether the introduction of the ERAS strategy has had a long-term positive effect on the quality of life after treatment (a survey 1 month and 6 months after leaving the hospital).
Detailed Description: Evaluation of the impact of implemented elements of the ERAS strategy on the results of surgical treatment of coronary artery disease in the aspect of:

* preoperative preparation (comprehensive information, premedication, hydration),
* haemodynamic stability (discontinuation of angiotensin-converting enzyme inhibitors and angiotensin II receptor blockers immediately before surgery), optimal pre- and intraoperative fluid therapy,
* occurrence of respiratory complications (assessment of the duration of mechanical ventilation and passive oxygen therapy),
* demand for painkillers in the postoperative period, after introducing the preemptive strategy,
* incidence of postoperative delirium,
* time to recovery of the normal bowel function (nausea, vomiting),
* possibility of early mobilisation on the first day after surgery,
* patient's satisfaction with treatment assessed on the basis of a survey carried out on the day before leaving the hospital.

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: