NCT05092867

Brief 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). 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
879

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2019

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

August 12, 2019

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 19, 2020

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2020

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 21, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 26, 2021

Completed
Last Updated

October 26, 2021

Status Verified

October 1, 2021

Enrollment Period

1.2 years

First QC Date

September 21, 2021

Last Update Submit

October 12, 2021

Conditions

Keywords

Post-Anesthesia Care UnitIntermediate Care UnitClinical pathwaysDecision making

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    2019/2020

Interventions

Healthcare workers filled the 2 VAS of the tool but it did not impact or change the care of the patient. (observational)

Eligibility Criteria

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

You may qualify if:

  • PACU patients admitted on Mondays
  • IMC patients admitted 7:30am-7:30pm on weekdays

You may not qualify if:

  • night admission
  • PACU patient ASA \< 3 or minor intervention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Geneva University Hospital

Geneva, 1205, Switzerland

Location

Related Publications (1)

  • 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.

Study Officials

  • Walder, Professor

    University Hospital, Geneva

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

September 21, 2021

First Posted

October 26, 2021

Study Start

August 12, 2019

Primary Completion

October 19, 2020

Study Completion

October 30, 2020

Last Updated

October 26, 2021

Record last verified: 2021-10

Locations