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NCT Number: NCT04261231

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Zurich, Institue of Anesthesiology

Zurich, Canton of Zurich, 8091, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

surgery and anesthesia

Procedure

Elective surgery in adults

Primary outcomes

  1. Duration of postoperative hospital stay

    Time frame: 1-60 days

    In-hospital days

  2. Duration if intensive care treatment

    Time frame: 600 hours

    ICU hours

  3. Duration of postoperative ventilation

    Time frame: 600 hours

    Ventilation hours

  4. Postoperative complications

    Time frame: 1-60 days

    thromboembolic, hepato-renal, neorologal, infections

Secondary outcomes

  1. Subjective wellbeeing

    Time frame: 1-60 days

    Likert scale 1 (excellent) to 5 (exteremely bad)

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Acronym: pUSISoutcome

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Feb 7, 2020
Registry last updated
Apr 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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