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

NCT ID: NCT04411186

Last Updated: 2024-07-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-22
• Study Completion Date: 2021-09-21

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Standard Enhanced Recovery After Surgery (ERAS) Protocol

Intervention Type: PROCEDURE

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

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%

Group Type: EXPERIMENTAL

ERAS and 5 Lung Protective Interventions

Intervention Type: 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%

Interventions

Standard Enhanced Recovery After Surgery (ERAS) Protocol

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

Intervention Type: PROCEDURE

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%

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

David Gutman

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David Gutman, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Locations

Medical University of South Carolina

Charleston, South Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Pro00094011

Identifier Type: -

Identifier Source: org_study_id