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

NCT04411186 | Completed Results DMC

• 1 other identifier: Pro00094011
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Surgery; Hepatobiliary Surgery

Outcome Measures

Primary Outcomes (1)

• Inspiratory Capacity

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

  2 hours

Secondary Outcomes (2)

• Oxygen Saturation (SPO2) Trends

  2 hours

• Incidence of Supplemental Oxygen Requirements

  2 hours

Study Arms (2)

Standard Enhanced Recovery After Surgery (ERAS) Protocol

ACTIVE COMPARATOR

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

Procedure: Standard Enhanced Recovery After Surgery (ERAS) Protocol

ERAS and 5 Lung Protective Interventions

EXPERIMENTAL

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%

Procedure: ERAS and 5 Lung Protective Interventions

Interventions

Standard Enhanced Recovery After Surgery (ERAS) Protocol PROCEDURE

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

Standard Enhanced Recovery After Surgery (ERAS) Protocol

ERAS and 5 Lung Protective Interventions PROCEDURE

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%

ERAS and 5 Lung Protective Interventions

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Interventions

Clinical Protocols

Intervention Hierarchy (Ancestors)

Therapeutics; Epidemiologic Study Characteristics; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation

Limitations and Caveats

Limitations to the study included difficulties with obtaining all data points during the post-anesthesia care unit (PACU) timeframe, specifically the use of supplemental oxygen in the PACU, therefore fewer conclusions can be drawn without this secondary outcome data.

Results Point of Contact

• Title: Dr. David Gutman, M.D., MBA, Associate Professor of Anesthesiology
• Organization: Medical University of South Carolina

gutman@musc.edu

843-792-5454

Study Officials

• David Gutman, MD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 27, 2020
• First Posted: June 2, 2020
• Study Start: March 22, 2021
• Primary Completion: September 21, 2021
• Study Completion: September 21, 2021
• Last Updated: July 5, 2024
• Results First Posted: July 5, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)