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

NCT ID: NCT03777150

Last Updated: 2018-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-10

Study Completion Date

2021-06-30

Brief Summary

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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

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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.

Conditions

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Postoperative Care Intensive Care

Keywords

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Intensive care postoperative care elective surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Group I: admitted into the ICU for postoperative care Group II: admitted into a standard ward for postoperative care
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Group ICU

Group ICU:patients are admitted directly into the ICU for postoperative care

Group Type EXPERIMENTAL

Postoperative care in Intensive care unit (ICU)

Intervention Type OTHER

Postoperative care in Intensive care unit (ICU)

Group Ward

Group Ward:patients are admitted directly into the standard ward for postoperative care

Group Type EXPERIMENTAL

Postoperative care in standard ward

Intervention Type OTHER

Postoperative care in standard ward

Interventions

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Postoperative care in Intensive care unit (ICU)

Postoperative care in Intensive care unit (ICU)

Intervention Type OTHER

Postoperative care in standard ward

Postoperative care in standard ward

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Saint Savvas Anticancer Hospital

OTHER

Sponsor Role lead

Responsible Party

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Georgia Micha

Anesthesiologist,MD, PhD Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anna Efthimiou, Head of the department

Role: STUDY_DIRECTOR

Saint Savvas Anticancer hospital of Athens

Locations

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Saint Savvas Anticancer Hospital of Athens

Athens, , Greece

Site Status RECRUITING

Countries

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Greece

Central Contacts

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Georgia Micha, MD, PhD

Role: CONTACT

Phone: 6974828254

Email: [email protected]

Vasiliki Chantziara, MD, PHD

Role: CONTACT

Phone: 6937173376

Email: [email protected]

Facility Contacts

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Georgia Micha, MD, MSc, PhD

Role: primary

Other Identifiers

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ICU postoperative care

Identifier Type: -

Identifier Source: org_study_id