Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05836285




Registration number
NCT05836285
Ethics application status
Date submitted
18/04/2023
Date registered
1/05/2023
Date last updated
14/08/2024

Titles & IDs
Public title
The ARRC III Trial of Advanced Recovery Room Care (ARRC).
Scientific title
The ARRC III Trial of Advanced Recovery Room Care (ARRC).
Secondary ID [1] 0 0
17557
Universal Trial Number (UTN)
Trial acronym
ARRCIII
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post-Surgical Complication 0 0
Economic Problems 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational [Patient Registry]
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Other interventions - ARRC
Other interventions - Usual Care

Medium risk patients undergoing surgery - Patients undergoing surgery designated as medium risk using NSQIP risk scores


Other interventions: ARRC
Eligible for ARRC and managed in ARRC unit

Other interventions: Usual Care
Eligible for ARRC but managed elsewhere as no ARRC bed available
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Days at Home after surgery
Timepoint [1] 0 0
90 days after surgery
Secondary outcome [1] 0 0
in-hospital complications
Timepoint [1] 0 0
out to 10 days after surgery
Secondary outcome [2] 0 0
mortality
Timepoint [2] 0 0
12 months after surgery
Secondary outcome [3] 0 0
cost-effectiveness
Timepoint [3] 0 0
90 days after surgery

Eligibility
Key inclusion criteria
* Scheduled for elective or unplanned surgery
* Scheduled to stay in hospital at least one night after surgery
* 30-day mortality of 0.5% to 8% by the US National Safety and Quality Improvement Program risk score (NSQIP)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Undergoing cardiac surgery
* Scheduled for postoperative Intensive Care Unit management

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
18/04/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2025
Actual
Sample size
Target
3000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 0 0
5000 - Adelaide

Funding & Sponsors
Primary sponsor type
Other
Name
University of Adelaide
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Royal Adelaide Hospital
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
A postoperative high-acuity model of care (ARRC) has been shown, in a prospective cohort study of approximately 850 patients, to produce a marked improvement in patient and hospital outcomes, and hospital costs, in medium risk patients (Ludbrook G et al., JAMA Surgery 2023).

The goal of this observational study is to examine the outcomes after non-cardiac surgery of a larger group of medium risk patients receiving different forms of care -ARRC and usual ward care. The main questions it aims to answer are:

what are the outcomes for patients and hospital after the different forms of care, who receives benefit from high acuity care, what underlies the improved outcomes seen with high acuity care.
Trial website
https://clinicaltrials.gov/study/NCT05836285
Trial related presentations / publications
Ludbrook G, Lloyd C, Story D, Maddern G, Riedel B, Richardson I, Scott D, Louise J, Edwards S. The effect of advanced recovery room care on postoperative outcomes in moderate-risk surgical patients: a multicentre feasibility study. Anaesthesia. 2021 Apr;76(4):480-488. doi: 10.1111/anae.15260. Epub 2020 Oct 7.
Public notes

Contacts
Principal investigator
Name 0 0
Guy Ludbrook, MBBS PhD
Address 0 0
Professor of Anaesthesia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Guy L Ludbrook, MBBS PhD
Address 0 0
Country 0 0
Phone 0 0
+61 413817901
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05836285