N/A
N=100
A Trial of Adding Lung Protective Strategies to Existing Enhanced Recovery After Surgery (ERAS) Protocols and Its Effects on Improving Post-Operative Lung Function
Colorectal Surgery · Hepatobiliary Surgery
Bottom Line
View on ClinicalTrials.gov: NCT04411186 ↗Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Jul 2024
Primary outcome: Primary: Inspiratory Capacity — 2,043.3; 2,012.2; 1,195.2; 1,233.3 mL
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Standard Enhanced Recovery After Surgery (ERAS) Protocol (Procedure); ERAS and 5 Lung Protective Interventions (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medical University of South Carolina
- Primary completion
- Sep 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Inspiratory Capacity |
2,043.3; 2,012.2; 1,195.2; 1,233.3; 1,313.9; 1,387.3 | — |
| SECONDARY Oxygen Saturation (SPO2) Trends |
— | — |
| SECONDARY Incidence of Supplemental Oxygen Requirements |
— | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- All subjects going for scheduled colorectal or hepatobiliary surgery at the MUSC ART hospital who would normally be utilizing the existing ERAS protocols
- English speaking
- Able to give informed consent
- Ages 18 years and older
Exclusion Criteria
- Emergency cases
- Pregnant subjects-confirmed by pre-operative urine pregnancy test
- Subjects with unique lung pathologies including, but not limited to: advanced pulmonary fibrosis, lung transplantation recipients, end stage COPD, pulmonary Hypertension
- Subjects on home O2
Data sourced from ClinicalTrials.gov (NCT04411186). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.