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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03189550
Other study ID # 140558
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 1, 2014
Est. completion date February 17, 2017

Study information

Verified date February 2019
Source Vanderbilt University Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Multimodal perioperative care pathways have evolved into enhanced recovery after surgery (ERAS). ERAS pathways improve the quality of patient care, reduce morbidity, and shorten length of stay. This project will test the hypothesis that implementation of a multi-modal ERAS perioperative care protocol in colorectal surgical patients will result in significantly reduced perioperative morbidity and mortality.


Description:

Multimodal perioperative care pathways have evolved into enhanced recovery after surgery (ERAS). ERAS pathways improve the quality of patient care, reduce morbidity, and shorten length of stay. This large quality improvement project will compare outcomes after standard perioperative practice with those after the implementation of a multi-modal evidence based care pathway, including standardized preoperative preparation, perioperative goal-directed fluid therapy (GFDT), multi-modal perioperative pain management, post operative nausea and vomiting prevention, surgical care and bowel isolation, and surgical site infection prevention. This project will test the hypothesis that implementation of a multi-modal ERAS perioperative care protocol in colorectal surgical patients will result in significantly reduced perioperative morbidity and mortality.


Recruitment information / eligibility

Status Completed
Enrollment 664
Est. completion date February 17, 2017
Est. primary completion date February 15, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- All patients who underwent colorectal surgery at Vanderbilt University Medical Center and whose data is stored in the perioperative data warehouse.

Exclusion Criteria:

- Age <18 years

- Weight <40 kg

Study Design


Intervention

Procedure:
ERAS perioperative care
Standard of care implementation of multi-modal evidence-based care pathway, including standardized preoperative preparation (medical and diet), perioperative goal-directed fluid therapy, multi-modal perioperative pain management, postoperative nausea and vomiting prevention, surgical care and bowel isolation, and surgical site infection prevention
Standard perioperative care
Standard perioperative care prior to implementation of ERAS care pathway
Noninvasive hemodynamic monitoring
Standard of care perioperative noninvasive hemodynamic monitoring with the ClearSight System (Edwards LifeSciences)

Locations

Country Name City State
United States Vanderbilt University Medical Center Nashville Tennessee

Sponsors (2)

Lead Sponsor Collaborator
Vanderbilt University Medical Center Edwards Lifesciences

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of surgical site infection Up to 30 days postoperative
Secondary ICU length of stay Up to 30 days postoperative
Secondary Time on ventilator Up to 30 days postoperative
Secondary Post operative pain assessment using 11-point Numeric Pain Rating Scale (NRS) Post operative pain assessed using NRS when 0 is no nausea and 10 is worst pain. Up to 30 days postoperative
Secondary Post operative anti emetic consumption Up to 30 days postoperative
Secondary Occurrence of postoperative complications Up to 30 days postoperative
Secondary Analgesia consumption Total opioid and non-opioid medication use Up to 30 days postoperative
Secondary Cardiac Index Using time traces for cardiac index during the perioperative period, the time in range of pre-defined parameters will be measured. 1 day
Secondary Stroke volume Using time traces for stroke volume during the perioperative period, the time in range of pre-defined parameters will be measured. 1 day
Secondary Systemic vascular resistance Using time traces for systemic vascular resistance during the perioperative period, the time in range of pre-defined parameters will be measured. 1 day
Secondary Heart rate Using time traces for heart rate during the perioperative period, the time in range of pre-defined parameters will be measured. 1 day
Secondary Hospital Length of stay (days) Up to 30 days post operative
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