Correlation of the "Preliminary Universal Surgical Invasiveness Score" (pUSIS) With Short Term Post-operative Clinical Outcome Parameters. An Observational Study (pUSISoutcome)

The scope of this investigation is to demonstrate that the pUSIS values correlate closely with short term post-operative clinical outcome parameters, thus making this scoring system a good predictor for the patients' postoperative course and may become a helpful instrument for decision making concerning the choice of postoperative surveillance and treatment. The obtained follow up results were subjected to correlation analyzis with the pUSIS values in order to determine their association and if possible to recognize threshold values that may indicate a suitable type/intensity of postoperative surveillance.

Study Overview

• Status: Completed
• Conditions: Outcome Assessment, Health Care
• Intervention / Treatment: Procedure: Surgery and anesthesia

Detailed Description

a number of 60 day-care as well as 100 in-hospital patients undergoing elective surgery in general anesthesia have been enrolled into this observational study. The recruitment of cases happened randomly on a daily basis according to the available operations in the surgical unit where the main investigator (NN) was performing her/his anesthesiological services. Thus there was no selection of specific surgeries or surgical disciplines.

Inclusion criteria: adult patients (>18 y) undergoing surgery in general anesthesia.

Exclusion criteria: emergency cases, patients aged < 18 years, pregnant women, inability to give informed consent.

The data acquisition consisted of calculation of the individual pUSIS for the selected cases by end of surgery, and by collecting in the follow up period the following set of short term parameters:

In-hospital patients

• time duration from end of surgery till discharge from PACU
• time duration from end of surgery till discharge from IMCU
• time duration from end of surgery till discharge from ICU
• time duration from end of surgery till discharge from hospital up to 30 days
• Occurrence and severity of complications the during hospital stay or up to 30 days according to a predefined list

Day-care patients

• time duration from end of surgery till discharge from PACU
• time duration from end of surgery till discharge from hospital
• Occurrence and severity of complications the during hospital stay according to a predefined list
• Occurrence of readmission due to complications within a period of 10 days after surgery

The predefined list of complications that could be observed during the follow up period consists of:

• Occurrence of postoperative pain that needed medical intervention, duration of this state, average severity level (according an ordinal scale with the levels: mild, moderate, severe)
• Occurrence of hemodynamic instability, duration of this state, average severity level (according an ordinal scale with the levels: mild, moderate, severe)
• Occurrence of postoperative hemorrhage, quantification in total ml of estimated blood loss
• Occurrence of respiratory support, duration of this state
• Occurrence of thrombo-embolic complications
• Occurrence of hepato-renal complications
• Occurrence of cerebral/neurological complications
• Occurrence of infectiological/inflamatory complications
• Average level of self-assessed subjective wellbeing (according an ordinal scale with the levels: excellent, rather good, moderate, bad, extremely bad)

The obtained follow up results were subjected to correlation analyzis with the pUSIS values in order to determine their association and if possible to recognize threshold values that may indicate a suitable type/intensity of postoperative surveillance.

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Switzerland
  • ZH
    • Zurich, ZH, Switzerland, 8091
      • University Hospital Zurich, Institue of Anesthesiology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

General surgical patients.

Description

Inclusion Criteria:

• adult patients (>18 y) undergoing surgery in general anesthesia

Exclusion Criteria:

• emergency cases
• patients aged < 18 years
• pregnant women
• inability to give informed consent

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of postoperative hospital stay	In-hospital days	1-60 days
Duration if intensive care treatment	ICU hours	600 hours
Duration of postoperative ventilation	Ventilation hours	600 hours
Postoperative complications	thromboembolic, hepato-renal, neorologal, infections	1-60 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective wellbeeing	Likert scale 1 (excellent) to 5 (exteremely bad)	1-60 days

Collaborators and Investigators

• Sponsor: University of Zurich

Publications and helpful links

General Publications

• Biro P, Gurman G. Proposal for a surrogate surgical invasiveness score to obtain a 'post hoc' quantification of surgical stress and tissue trauma in the context of postoperative outcome assessments. Br J Anaesth. 2014 May;112(5):951-3. doi: 10.1093/bja/aeu127. No abstract available.
• Biro P, Sermeus L, Jankovic R, Savic N, Onutu AH, Ionescu D, Godoroja D, Gurman G. Basic Features and Clinical Applicability of 'Preliminary Universal Surgical Invasiveness Score' (pUSIS): A Multi-Centre Pilot Study. Turk J Anaesthesiol Reanim. 2017 Feb;45(1):9-15. doi: 10.5152/TJAR.2017.77785. Epub 2017 Feb 1.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2019
• Primary Completion (Actual): March 31, 2020
• Study Completion (Actual): March 31, 2020

Study Registration Dates

• First Submitted: February 6, 2020
• First Submitted That Met QC Criteria: February 6, 2020
• First Posted (Actual): February 7, 2020

Study Record Updates

• Last Update Posted (Actual): April 2, 2020
• Last Update Submitted That Met QC Criteria: April 1, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: BASEC 2016-00498

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plan to share.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No