Outcome Assessment, Health CarepUSISoutcomeNCT04261231
Correlation of the "Preliminary Universal Surgical Invasiveness Score" (pUSIS) With Short Term Post-operative Clinical Outcome Parameters. An Observational Study
An observational study of Outcome Assessment, Health Care, run by University of Zurich at 1 site in Switzerland.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Outcome Assessment, Health Care
- What is being tested?
- Surgery and anesthesia
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Nov 2019to 31 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: General surgical patients.
Who may be able to join
- adult patients (>18 y) undergoing surgery in general anesthesia
Who cannot join
- emergency cases
- patients aged < 18 years
- pregnant women
- inability to give informed consent
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Zurich, Institue of Anesthesiology
Zurich, Canton of Zurich, 8091
About this 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.
Read the 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.
- Conditions
- Outcome Assessment, Health Care
- Being tested
- Surgery and anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgery and anesthesiaProcedure or surgery
Elective surgery in adults
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of postoperative hospital stay
In-hospital days
Measured: 1-60 days
Duration if intensive care treatment
ICU hours
Measured: 600 hours
Duration of postoperative ventilation
Ventilation hours
Measured: 600 hours
Postoperative complications
thromboembolic, hepato-renal, neorologal, infections
Measured: 1-60 days
Secondary outcomes (1)
Subjective wellbeeing
Likert scale 1 (excellent) to 5 (exteremely bad)
Measured: 1-60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2020
- Study start1 Nov 2019
- Primary completion31 Mar 2020
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Outcome Assessment, Health CareStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04261231
- Sponsor's protocol ID
- BASEC 2016-00498
- Acronym
- pUSISoutcome
- Status last verified
- Mar 2020
- First submitted
- 6 Feb 2020
- Last updated
- 2 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share.
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.
PubMed 24771798Biro 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.
PubMed 28377835
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of the "Preliminary Universal Surgical Invasiveness Score" (pUSIS) With Short Term Post-operative Clinical Outcome Parameters. An Observational Study
- ClinicalTrials.gov ID
- NCT04261231
- Acronym / sponsor ID
- pUSISoutcome / BASEC 2016-00498
- Conditions
- Outcome Assessment, Health Care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 7 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- General surgical patients.
Key inclusion criteria (1 listed)
- adult patients (>18 y) undergoing surgery in general anesthesia
Key exclusion criteria (4 listed)
- emergency cases
- patients aged < 18 years
- pregnant women
- inability to give informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgery and anesthesiaElective surgery in adults | Procedure or surgery | – |
Primary outcome
Duration of postoperative hospital stay
Time frame: 1-60 days
In-hospital days
Duration if intensive care treatment
Time frame: 600 hours
ICU hours
Duration of postoperative ventilation
Time frame: 600 hours
Ventilation hours
Postoperative complications
Time frame: 1-60 days
thromboembolic, hepato-renal, neorologal, infections
1 secondary outcome
Subjective wellbeeing
Time frame: 1-60 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2020.
- Background: PubMed 24771798Biro 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.
- Background: PubMed 28377835Biro 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.
- Individual participant dataSharing planned: No. No plan to share.
Related trials for Outcome Assessment, Health Care
Recruiting
Clinical Outcome Assessment for AT & BCI
Spinal Cord Injury, ALS (Amyotrophic Lateral Sclerosis)
Not yet recruiting
Transcutaneous Auricular Vagus Nerve Stimulation Combined With Lifestyle Intervention for Visceral Fat Reduction in Adults With Overweight or Obesity
Overweight, Obesity
Recruiting
Building Core Competencies of Taiwanese Care Food Specialists: Curriculum Design and Outcome Assessment
Healthy
Active, not recruitingObservational study
Thailand Birth and Infant Outcomes Study
Outcome Assessment
Active, not recruitingObservational study
Study on Prognosis of Acutely Ruptured Intracranial Aneurysms
Aneurysmal Subarachnoid Hemorrhage, Endovascular Procedures
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Outcome Assessment, Health Care, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of postoperative hospital stay (time frame: 1-60 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04261231, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2020.