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 Clinical Trial

Official title:

A Trial of Adding Lung Protective Strategies to Existing Enhanced Recovery After Surgery (ERAS) Protocols and Its Effects on Improving Post-Operative Lung Function

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04411186
• Other study ID #: Pro00094011
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Colorectal Surgery
• Hepatobiliary Surgery

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