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

Medical University of South Carolina (MUSC)

Status: Completed

Conditions: Colorectal Surgery; Hepatobiliary Surgery

Treatments: Procedure: Standard Enhanced Recovery After Surgery (ERAS) Protocol; Procedure: ERAS and 5 Lung Protective Interventions

Study type: Interventional

Funder types: Other

Identifiers

NCT04411186

Pro00094011

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Standard Enhanced Recovery After Surgery (ERAS) Protocol

Active Comparator group

Description:

Control for this study will be the standard MUSC ERAS protocol - fluid intake, hydration, anti-emetics, pain control, and several other considerations.

Treatment:

Procedure: Standard Enhanced Recovery After Surgery (ERAS) Protocol

ERAS and 5 Lung Protective Interventions

Experimental group

Description:

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%

Treatment:

Procedure: ERAS and 5 Lung Protective Interventions