Postoperative Intensive Care Surveillance

Post-operative Adhesion(s) Clinical Trial

— PoIS  

Official title:

POSTOPERATIVE INTENSIVE CARE SURVEILLANCE. A Tool to Optimize ICU-beds Management?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02894788
• Other study ID #: PoIS
• Status: Completed
• Phase: N/A
• First received: July 19, 2016
• Last updated: September 5, 2016
• Start date: March 2015
• Est. completion date: September 2015

Study information

• Verified date: September 2016
• Source: Istituto Clinico Humanitas
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical Trial Summary

Several score systems were created to stratify perioperative risk and predict mortality. The study rises from the needing of a rapid and simple system to identify the patient worthy of Postoperative Intensive Surveillance. In the first phase Authors retrospectively investigated on patients underwent to elective surgery searching for determining factors (DFs) for postoperative ICU admission. Later, Researchers prospectively studied how DFs could predict the admission in ICU of consecutive patients scheduled for elective surgery during a three-months period and created an index, named PoIS (Post-operative Intensive Surveillance), based on the results of this analysis. Authors used surgical invasiveness (SI), Diabetes Mellitus (DM), Myocardiopathy (MCP), Cerebrovascular Disease (CVD), Body Mass Index (BMI), age, serum creatinine level (sCr), Tiffenau Index (TI) and male sex for the development of the original model. Authors classified SI from G1 (lowest) to G5 (highest).

The results show that the power of prediction of postoperative morbidity of PoIS and POSSUM resulted coincident and better than the American Society of Anesthesiology scoring system.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2498
• Est. completion date: September 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• elective surgery

Exclusion Criteria:

• multiple surgery

• age less than 18

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Post-operative Adhesion(s)
• Tissue Adhesions

Intervention

Other:
• ICU admission

Locations

Country	Name	City	State
Italy	Humanitas Research Hospital - Dept. Anesthesia and Intensive Care Unit	Rozzano	Milano

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Clinico Humanitas

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-operative intensive care surveillance scoring system		1 hour after the end of surgery	Yes