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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04411186
Other study ID # Pro00094011
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 22, 2021
Est. completion date September 21, 2021

Study information

Verified date March 2023
Source Medical University of South Carolina
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date September 21, 2021
Est. primary completion date September 21, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Standard Enhanced Recovery After Surgery (ERAS) Protocol
Subjects receive standard MUSC ERAS protocol - fluid intake, hydration, anti-emetics, pain control, and several other considerations.
ERAS and 5 Lung Protective Interventions
Subjects will receive the standard MUSC ERAS protocol - fluid intake, hydration, anti-emetics, pain control, and several other considerations. The subject will also receive the following lung protective interventions: Pressure control ventilation-volume guaranteed (PCV-VG) ventilation at approximately 7cc/kg of predicted body weight (derived from combination of sex and height) Positive end-expiratory pressure (PEEP) 7cm H2O5 Immediately post intubation recruitment breath (30cm water for 30 seconds) Every 1 hour recruitment breath (30cm water for 30 seconds) 40% FIO2 initially - titrate up as necessary to maintain SPO2 >94%

Locations

Country Name City State
United States Medical University of South Carolina Charleston South Carolina

Sponsors (1)

Lead Sponsor Collaborator
Medical University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Inspiratory Capacity The primary outcome of interest is the inspiratory capacity obtained in the PACU via the incentive spirometer. 2 hours
Secondary Oxygen Saturation (SPO2) Trends numerical value for SPO2 trends in 15 min intervals in the Post Operative Care Unit (PACU) 2 hours
Secondary Incidence of supplemental Oxygen Requirements Recording of use or lack thereof of supplemental oxygen in PACU in 15 minute intervals. 2 hours
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