Perioperative ComplicationPOTraToolNCT05092867
Reliability and Validity of a New Postoperative Track Assessment Tool
An observational study of Perioperative Complication, run by University Hospital, Geneva at 1 site in Switzerland.
Trial summary
This prospective observational study investigated the validity and reliability of a new postoperative track assessment tool. We hypothesized, first, that this tool estimates the indication and benefit of a management in an intermediate care unit (IMC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Perioperative Complication
- What is being tested?
- Po Tra tool
- How many people
- 879 participants
- Where
- 1 siteSwitzerland
- Study dates
- 12 Aug 2019to 30 Oct 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: This study was a random sample from the PACU and IMC patients' population. Included patients' variables for demographic description of the population of interest and for the validity testing were: Age in years, gender (male / female), ASA physical score classification (ASA PS), do not resuscitate order (DNR), duration of intervention (min), severity of intervention (minor/intermediate/major), type of surgery (abdominal, orthopedic, trauma and other surgical and non-surgical interventions), elective or non-elective, palliative intervention, SAPS II (admission (2 h after arrival in IMC)), NEMS (admission (2 h after arrival) and during stay in IMC), SAS. Participating raters were voluntary health care providers working in the peri-interventional unit (PACU and IMC).
Who may be able to join
- PACU patients admitted on Mondays
- IMC patients admitted 7:30am-7:30pm on weekdays
Who cannot join
- night admission
- PACU patient ASA < 3 or minor intervention
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reliability and Validity of a New Postoperative Track Assessment Tool - a Prospective Observational Study
This prospective observational study investigated the validity and reliability of a new postoperative track assessment tool. We hypothesized, first, that this tool estimates the indication and benefit of a management in an intermediate care unit (IMC). Second, we hypothesized that a) health care providers of IMC or postoperative anaesthesia care unit (PACU) have similar estimations using this tool and b) that this estimation is accurately established in the first 2 hours.
Read the detailed description
The tool includes 2 visual analog scale (VAS) scores estimating indication of an IMC admission and benefit of an IMC stay. The tool was tested in a PACU and in an IMC unit of a Swiss tertiary centre in 2019/2020 (before COVID pandemic). Three raters: one nurse, one physician in charge and the consultant physician, were asked to fill the VAS at the same time for each included patient. The score was done in the 2 first hours following admission in the unit and during the multi professional morning round at day 1.
Reliability was estimated by testing internal consistency (homogeneity), interrater reliability and agreement and test-retest validity (stability). Validity included content validity, construct validity and criterion validity.
- Conditions
- Perioperative Complication
- Being tested
- Po Tra tool
- Keywords
- Post-Anesthesia Care Unit, Intermediate Care Unit, Clinical pathways, Decision making
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Po Tra toolOther
Healthcare workers filled the 2 VAS of the tool but it did not impact or change the care of the patient. (observational)
What is being measured
The primary outcome is the main question the study is designed to answer.
Intermediate Care (IMC) indication (VASi)
Health care raters graded the IMC indication (or allocative efficiency) for each patient on a visual analog scale grading from 0 (very low indication of an IMC management) to 100 (very high indication of an IMC management), namely VASi.
Measured: 2019/2020
Intermediate Care benefit (VASb)
Health care raters graded the IMC benefit (or health gain) for each patient on a visual analog scale grading from 0 (very low benefit from an IMC management) to 100 (very high benefit from an IMC management), namely VASb.
Measured: 2019/2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2021
- Study start12 Aug 2019
- Primary completion19 Oct 2020
- Study completion30 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Perioperative ComplicationStudies of the same condition, open and under way.
- More trials run by University Hospital, GenevaThe 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
- 879 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laurelie Perret, University Hospital, Geneva
- Investigators
- Walder, Professor, Study director, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05092867
- Sponsor's protocol ID
- 14032019
- Acronym
- POTraTool
- Status last verified
- Oct 2021
- First submitted
- 21 Sep 2021
- Last updated
- 26 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Perret L, Buclin CP, Courvoisier DS, Walder B. Reliability and validity of a new postoperative track assessment tool (PoTra-tool) as a decision-making aid: A prospective observational study. Eur J Anaesthesiol Intensive Care. 2025 May 29;4(4):e0076. doi: 10.1097/EA9.0000000000000076. eCollection 2025 Aug.
PubMed 40756574
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability and Validity of a New Postoperative Track Assessment Tool - a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT05092867
- Acronym / sponsor ID
- POTraTool / 14032019
- Conditions
- Perioperative Complication
- Keywords
- Post-Anesthesia Care Unit, Intermediate Care Unit, Clinical pathways, Decision making
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 879 participants (actual)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- 12 Aug 2019 (actual)
- Primary completion
- 19 Oct 2020 (actual)
- Study completion
- 30 Oct 2020 (actual)
- First posted
- 26 Oct 2021 (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.
This prospective observational study investigated the validity and reliability of a new postoperative track assessment tool. We hypothesized, first, that this tool estimates the indication and benefit of a management in an intermediate care unit (IMC). Second, we hypothesized that a) health care providers of IMC or postoperative anaesthesia care unit (PACU) have similar estimations using this tool and b) that this estimation is accurately established in the first 2 hours.
Detailed description
The tool includes 2 visual analog scale (VAS) scores estimating indication of an IMC admission and benefit of an IMC stay. The tool was tested in a PACU and in an IMC unit of a Swiss tertiary centre in 2019/2020 (before COVID pandemic). Three raters: one nurse, one physician in charge and the consultant physician, were asked to fill the VAS at the same time for each included patient. The score was done in the 2 first hours following admission in the unit and during the multi professional morning round at day 1.
Reliability was estimated by testing internal consistency (homogeneity), interrater reliability and agreement and test-retest validity (stability). Validity included content validity, construct validity and criterion validity.
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
- This study was a random sample from the PACU and IMC patients' population. Included patients' variables for demographic description of the population of interest and for the validity testing were: Age in years, gender (male / female), ASA physical score classification (ASA PS), do not resuscitate order (DNR), duration of intervention (min), severity of intervention (minor/intermediate/major), type of surgery (abdominal, orthopedic, trauma and other surgical and non-surgical interventions), elective or non-elective, palliative intervention, SAPS II (admission (2 h after arrival in IMC)), NEMS (admission (2 h after arrival) and during stay in IMC), SAS. Participating raters were voluntary health care providers working in the peri-interventional unit (PACU and IMC).
Key inclusion criteria (2 listed)
- PACU patients admitted on Mondays
- IMC patients admitted 7:30am-7:30pm on weekdays
Key exclusion criteria (2 listed)
- night admission
- PACU patient ASA < 3 or minor intervention
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 |
|---|---|---|
| Po Tra toolHealthcare workers filled the 2 VAS of the tool but it did not impact or change the care of the patient. (observational) | Other | – |
Primary outcome
Intermediate Care (IMC) indication (VASi)
Time frame: 2019/2020
Health care raters graded the IMC indication (or allocative efficiency) for each patient on a visual analog scale grading from 0 (very low indication of an IMC management) to 100 (very high indication of an IMC management), namely VASi.
Intermediate Care benefit (VASb)
Time frame: 2019/2020
Health care raters graded the IMC benefit (or health gain) for each patient on a visual analog scale grading from 0 (very low benefit from an IMC management) to 100 (very high benefit from an IMC management), namely VASb.
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 26 Oct 2021.
- Derived from this study: PubMed 40756574Perret L, Buclin CP, Courvoisier DS, Walder B. Reliability and validity of a new postoperative track assessment tool (PoTra-tool) as a decision-making aid: A prospective observational study. Eur J Anaesthesiol Intensive Care. 2025 May 29;4(4):e0076. doi: 10.1097/EA9.0000000000000076. eCollection 2025 Aug.
- Individual participant dataSharing planned: Undecided
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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.
Walder, Professor study director
University Hospital, Geneva
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 Perioperative Complication, run by University Hospital, Geneva 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 2 inclusion and 2 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 26 Oct 2021. 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?
Intermediate Care (IMC) indication (VASi) (time frame: 2019/2020). The study lists 2 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 NCT05092867, which also lists 1 linked publication.
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 26 Oct 2021.