Is There a Benefit of Postoperative ICU Management After Elective Surgery in Critical Ill Patients?

Not Applicable

• Conditions: Postoperative Care; Intensive Care
• Interventions: Other: Postoperative care in standard ward; Other: Postoperative care in Intensive care unit (ICU)

• Registration Number: NCT03777150
• Lead Sponsor: Saint Savvas Anticancer Hospital

Brief Summary

Postoperative care of high risk patients in the Intensive Care Unit (ICU) has for long been considered to be the gold standard of care in terms of reducing perioperative mortality.New evidence from a 7-day cohort study involving 27 countries comes to question this practice. The primary objective of our study is to detect any benefit of postoperative ICU care after elective surgery in terms of patient's outcome, length of hospital stay, complications and cost.

Detailed Description

A prospective analysis of high perioperative risk patients that are about to be subjected into an elective operation will be included into the study. They will be allocated into two groups. Group ICU patients are those that are admitted into the ICU for postoperative care and those that are admitted into a standard ward consist Group Ward. Demographic data, the length of hospital stay, the outcome, the need of mechanical ventilation, the complications and the total cost will be recorded.

Study Timeline

• Study Start: 2018-10-10
• Status Verified: 2018-12
• Study First Submitted: 2018-12-10
• Study First Submitted QC: 2018-12-14
• Last Update Submitted: 2018-12-14
• Study First Posted: 2018-12-17
• Last Update Posted: 2018-12-17
• Primary Completion: 2020-12
• Study Completion: 2021-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• All patients that will be scheduled for an elective operation and are considered to be in a high perioperative risk

Exclusion Criteria

• Patients that are operated on an emergency basis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group Ward	Postoperative care in standard ward	Group Ward:patients are admitted directly into the standard ward for postoperative care
Group ICU	Postoperative care in Intensive care unit (ICU)	Group ICU:patients are admitted directly into the ICU for postoperative care

Primary Outcome Measures

Name	Time	Method
Total length of hospital stay	From date of hospital admission until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 6 months	The total length of patient's hospital stay will be recorded

Secondary Outcome Measures

Name	Time	Method
Postoperative length of hospital stay	From date of surgical operation until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 6 months	The postoperative length of patient's hospital stay will be recorded
Preoperative length of hospital stay	From date of hospital admission until the date of operation or date of death from any cause, whichever came first, assessed up to 6 months	The preoperative length of patient's hospital stay will be recorded
Postoperative complications	From date of surgical operation until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 6 months	All postoperative complications will be recorded
Postoperative cost of hospital care	From date of surgical operation until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 6 months	The postoperative cost of hospital care will be recorded for every patient
Patient's outcome at 28 days postoperatively	From the first postoperative day until 28 days postoperatively	28 day postoperative mortality will be recorded
Total cost of hospital care	From date of hospital admission until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 6 months	The total cost of hospital care will be recorded for every patient

Trial Locations

Locations (1)

Saint Savvas Anticancer Hospital of Athens; 🇬🇷 Athens, Greece