A Trial of Adding Lung Protective Strategies to Existing Enhanced Recovery After Surgery (ERAS) Protocols and Its Effects on Improving Post-Operative Lung Function
CompletedNAResults postedLast updated 5 July 2024
What this trial tests
NA trial testing Standard Enhanced Recovery After Surgery (ERAS) Protocol in Colorectal Surgery in 100 participants. Completed in 21 September 2021.
Timeline
22 March 2021
Primary endpoint 21 September 2021
21 September 2021
Quick facts
Lead sponsor
Medical University of South Carolina
Phase
NA
Status
Completed
Study type
INTERVENTIONAL
Allocation
randomized
Design
parallel
Masking
none
Primary purpose
treatment
Enrollment
100
Start date
22 March 2021
Primary completion
21 September 2021
Estimated completion
21 September 2021
Sites
1 location across United States
Drugs / interventions tested
Standard Enhanced Recovery After Surgery (ERAS) Protocol
18 and older, any sex, with Colorectal Surgery or Hepatobiliary Surgery. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Inspiratory CapacityPrimary· 2 hours
The primary outcome of interest is the inspiratory capacity obtained in the PACU via the incentive spirometer.
Preoperative incentive spirometry (average)
Group
Value
95% CI
Standard Enhanced Recovery After Surgery (ERAS) Protocol
2,043.3
± 628.4
ERAS and 5 Lung Protective Interventions
2,012.2
± 895.2
Postoperative incentive spirometry 30 min (average)
Group
Value
95% CI
Standard Enhanced Recovery After Surgery (ERAS) Protocol
1,195.2
± 715.0
ERAS and 5 Lung Protective Interventions
1,233.3
± 894.1
Postoperative incentive spirometry 1 h (average)
Group
Value
95% CI
Standard Enhanced Recovery After Surgery (ERAS) Protocol
1,313.9
± 618.1
ERAS and 5 Lung Protective Interventions
1,387.3
± 975.3
Postoperative incentive spirometry 2 h (average)
Group
Value
95% CI
Standard Enhanced Recovery After Surgery (ERAS) Protocol
1,376.3
± 651.2
ERAS and 5 Lung Protective Interventions
1,454.8
± 906.4
Postoperative incentive spirometry total (average)
Group
Value
95% CI
Standard Enhanced Recovery After Surgery (ERAS) Protocol
1,253.5
± 593.7
ERAS and 5 Lung Protective Interventions
1,390.4
± 964.9
Sponsor's own description
The objective of this study is to determine whether the addition of lung protective strategies to existing enhanced recovery after surgery (ERAS) protocols for colorectal surgeries and hepatobiliary surgeries will improve post-operative lung function.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Sponsor: as reported to ClinicalTrials.gov by Medical University of South Carolina
Last refreshed: 5 July 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04411186.