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 Carolina100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Colorectal Surgery Hepatobiliary Surgery

Interventions

Standard Enhanced Recovery After Surgery (ERAS) ProtocolPROCEDURE

Subjects receive standard MUSC ERAS protocol - fluid intake, hydration, anti-emetics, pain control, and several other considerations.

ERAS and 5 Lung Protective InterventionsPROCEDURE

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%

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Medical University of South Carolina

Charleston, South Carolina, United States

Outcomes

Primary Outcomes

Inspiratory Capacity

The primary outcome of interest is the inspiratory capacity obtained in the PACU via the incentive spirometer.

Time frame: 2 hours

Secondary Outcomes

Oxygen Saturation (SPO2) Trends

Numerical value for SPO2 trends in 15 min intervals in the Post Operative Care Unit (PACU)

Time frame: 2 hours

Incidence of Supplemental Oxygen Requirements

Recording of use or lack thereof of supplemental oxygen in PACU in 15 minute intervals.

Time frame: 2 hours

Data from ClinicalTrials.gov

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