NCT02894788

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,498

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

July 19, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 9, 2016

Completed
Last Updated

September 9, 2016

Status Verified

September 1, 2016

Enrollment Period

5 months

First QC Date

July 19, 2016

Last Update Submit

September 5, 2016

Conditions

Post-operative Adhesion(s)

Outcome Measures

Primary Outcomes (1)

  • Post-operative intensive care surveillance scoring system

    1 hour after the end of surgery

Study Arms (2)

ICU

patients postoperatively admitted to ICU

Other: ICU admission

no ICU

patients who didn't required ICU admission postoperatively

Interventions

ICU admissionOTHER
ICU

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

surgical population

You may qualify if:

  • elective surgery

You may not qualify if:

  • multiple surgery
  • age less than 18

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Humanitas Research Hospital - Dept. Anesthesia and Intensive Care Unit

Rozzano, Milano, 20089, Italy

Location

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2016

First Posted

September 9, 2016

Study Start

March 1, 2015

Primary Completion

August 1, 2015

Study Completion

September 1, 2015

Last Updated

September 9, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)