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

Not Applicable

Completed

• Conditions: Colorectal Surgery; Hepatobiliary Surgery
• Interventions: Procedure: Standard Enhanced Recovery After Surgery (ERAS) Protocol; Procedure: ERAS and 5 Lung Protective Interventions

• Registration Number: NCT04411186
• Lead Sponsor: Medical University of South Carolina

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-05-27
• Study First Submitted QC: 2020-05-27
• Study First Posted: 2020-06-02
• Study Start: 2021-03-22
• Primary Completion: 2021-09-21
• Study Completion: 2021-09-21
• Results First Submitted: 2023-03-29
• Status Verified: 2024-07
• Results First Submitted QC: 2024-07-02
• Last Update Submitted: 2024-07-02
• Results First Posted: 2024-07-05
• Last Update Posted: 2024-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Enhanced Recovery After Surgery (ERAS) Protocol	Standard Enhanced Recovery After Surgery (ERAS) Protocol	Control for this study will be the standard MUSC ERAS protocol - fluid intake, hydration, anti-emetics, pain control, and several other considerations.
ERAS and 5 Lung Protective Interventions	ERAS and 5 Lung Protective Interventions	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: 1. Pressure control ventilation-volume guaranteed (PCV-VG) ventilation at approximately 7cc/kg of predicted body weight (derived from combination of sex and height) 2. Positive end-expiratory pressure (PEEP) 7cm H2O5 3. Immediately post intubation recruitment breath (30cm water for 30 seconds) 4. Every 1 hour recruitment breath (30cm water for 30 seconds) 5. 40% FIO2 initially - titrate up as necessary to maintain SPO2 \>94%

Primary Outcome Measures

Name	Time	Method
Inspiratory Capacity	2 hours	The primary outcome of interest is the inspiratory capacity obtained in the PACU via the incentive spirometer.

Secondary Outcome Measures

Name	Time	Method
Oxygen Saturation (SPO2) Trends	2 hours	Numerical value for SPO2 trends in 15 min intervals in the Post Operative Care Unit (PACU)
Incidence of Supplemental Oxygen Requirements	2 hours	Recording of use or lack thereof of supplemental oxygen in PACU in 15 minute intervals.

Trial Locations

Locations (1)

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States