Clinical trial NCT05092867: Reliability and Validity of a New Postoperative Track Assessment Tool
Official title: Reliability and Validity of a New Postoperative Track Assessment Tool - a Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Perioperative Complication
Keywords: Post-Anesthesia Care Unit
Intermediate Care Unit
Clinical pathways
Decision making
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2021-10-26
Enrollment: 879
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_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).

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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Intermediate Care (IMC) indication (VASi)
timeFrame: 2019/2020
measure: Intermediate Care benefit (VASb)
timeFrame: 2019/2020
Secondary outcomes:
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: Geneva University Hospital
Study officials:
affiliation: University Hospital, Geneva
name: Walder, Professor
role: STUDY_DIRECTOR
References: