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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Inspiratory Capacity | The primary outcome of interest is the inspiratory capacity obtained in the PACU via the incentive spirometer. | 2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Oxygen Saturation (SPO2) Trends | Numerical value for SPO2 trends in 15 min intervals in the Post Operative Care Unit (PACU) | 2 hours |
| Incidence of Supplemental Oxygen Requirements | Recording of use or lack thereof of supplemental oxygen in PACU in 15 minute intervals. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Gutman, MD | Medical University of South Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. Standard Enhanced Recovery After Surgery (ERAS) Protocol: Subjects receive standard MUSC ERAS protocol - fluid intake, hydration, anti-emetics, pain control, and several other considerations. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 31, 2021 |
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| 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% |
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| 2 hours |
| FG001 | 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:
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% |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. Standard Enhanced Recovery After Surgery (ERAS) Protocol: Subjects receive standard MUSC ERAS protocol - fluid intake, hydration, anti-emetics, pain control, and several other considerations. |
| BG001 | 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:
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% |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||
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| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Body Mass Index (BMI) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
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| Primary | Inspiratory Capacity | The primary outcome of interest is the inspiratory capacity obtained in the PACU via the incentive spirometer. | Posted | Mean | Standard Deviation | mL | 2 hours |
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| Secondary | Oxygen Saturation (SPO2) Trends | Numerical value for SPO2 trends in 15 min intervals in the Post Operative Care Unit (PACU) | Data was for this outcome was not documented by nursing staff in the medical record, therefore this outcome was unable to be included and analyzed. | Posted | 2 hours |
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| Secondary | Incidence of Supplemental Oxygen Requirements | Recording of use or lack thereof of supplemental oxygen in PACU in 15 minute intervals. | Data was for this outcome was not documented by nursing staff in the medical record, therefore this outcome was unable to be included and analyzed. | Posted | 2 hours |
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Adverse events were collected from the time of consent and enrollment through each patient's completion of the study which was until they leave the PACU, or until two hours has passed, whichever was less.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Standard Enhanced Recovery After Surgery (ERAS) Protocol: Subjects receive standard MUSC ERAS protocol - fluid intake, hydration, anti-emetics, pain control, and several other considerations. | 0 | 50 | 0 | 50 | 0 | 50 |
| EG001 | 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:
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% | 0 | 49 | 0 | 49 | 0 | 49 |
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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.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. David Gutman, M.D., MBA, Associate Professor of Anesthesiology | Medical University of South Carolina | 843-792-5454 | gutman@musc.edu |
| Mar 28, 2023 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D002985 | Clinical Protocols |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D016020 | Epidemiologic Study Characteristics |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Title | Measurements |
|---|---|
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| 51-70 years |
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| ≥ 71 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Normal ((≥ 18.5, < 25) |
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| Overweight (≥ 25, < 30) |
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| Obese (≥ 30) |
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| Postoperative incentive spirometry 1 h (average) |
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| Postoperative incentive spirometry 2 h (average) |
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| Postoperative incentive spirometry total (average) |
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