Colorectal Surgery, Hepatobiliary Surgery
Conditions
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.
Interventions
PROCEDUREStandard Enhanced Recovery After Surgery (ERAS) Protocol
Subjects receive standard MUSC ERAS protocol - fluid intake, hydration, anti-emetics, pain control, and several other considerations.
PROCEDUREERAS 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%
Sponsors
Medical University of South Carolina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Inspiratory Capacity | 2 hours | The primary outcome of interest is the inspiratory capacity obtained in the PACU via the incentive spirometer. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Oxygen Saturation (SPO2) Trends | 2 hours | Numerical value for SPO2 trends in 15 min intervals in the Post Operative Care Unit (PACU) |
| Incidence of Supplemental Oxygen Requirements | 2 hours | Recording of use or lack thereof of supplemental oxygen in PACU in 15 minute intervals. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 50 |
| 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%
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% | 49 |
| Total | 99 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawn due to protocol violation | 0 | 1 |
Baseline characteristics
| Characteristic | Standard Enhanced Recovery After Surgery (ERAS) Protocol | ERAS and 5 Lung Protective Interventions | Total |
|---|---|---|---|
| Age, Customized ≤ 30 years | 2 Participants | 1 Participants | 3 Participants |
| Age, Customized 31-50 years | 9 Participants | 9 Participants | 18 Participants |
| Age, Customized 51-70 years | 28 Participants | 26 Participants | 54 Participants |
| Age, Customized ≥ 71 years | 11 Participants | 13 Participants | 24 Participants |
| Body Mass Index (BMI) Normal ((≥ 18.5, < 25) | 14 Participants | 15 Participants | 29 Participants |
| Body Mass Index (BMI) Obese (≥ 30) | 15 Participants | 14 Participants | 29 Participants |
| Body Mass Index (BMI) Overweight (≥ 25, < 30) | 19 Participants | 17 Participants | 36 Participants |
| Body Mass Index (BMI) Underweight (<18.5) | 2 Participants | 3 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 50 Participants | 49 Participants | 99 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants | 9 Participants | 16 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 42 Participants | 40 Participants | 82 Participants |
| Sex: Female, Male Female | 23 Participants | 30 Participants | 53 Participants |
| Sex: Female, Male Male | 27 Participants | 19 Participants | 46 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 50 | 0 / 49 |
| other Total, other adverse events | 0 / 50 | 0 / 49 |
| serious Total, serious adverse events | 0 / 50 | 0 / 49 |
Outcome results
Primary
Inspiratory Capacity
The primary outcome of interest is the inspiratory capacity obtained in the PACU via the incentive spirometer.
Time frame: 2 hours
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard Enhanced Recovery After Surgery (ERAS) Protocol | Inspiratory Capacity | Preoperative incentive spirometry (average) | 2,043.3 mL | Standard Deviation 628.4 |
| Standard Enhanced Recovery After Surgery (ERAS) Protocol | Inspiratory Capacity | Postoperative incentive spirometry 30 min (average) | 1,195.2 mL | Standard Deviation 715 |
| Standard Enhanced Recovery After Surgery (ERAS) Protocol | Inspiratory Capacity | Postoperative incentive spirometry 1 h (average) | 1,313.9 mL | Standard Deviation 618.1 |
| Standard Enhanced Recovery After Surgery (ERAS) Protocol | Inspiratory Capacity | Postoperative incentive spirometry total (average) | 1,253.5 mL | Standard Deviation 593.7 |
| Standard Enhanced Recovery After Surgery (ERAS) Protocol | Inspiratory Capacity | Postoperative incentive spirometry 2 h (average) | 1,376.3 mL | Standard Deviation 651.2 |
| ERAS and 5 Lung Protective Interventions | Inspiratory Capacity | Postoperative incentive spirometry 2 h (average) | 1,454.8 mL | Standard Deviation 906.4 |
| ERAS and 5 Lung Protective Interventions | Inspiratory Capacity | Preoperative incentive spirometry (average) | 2,012.2 mL | Standard Deviation 895.2 |
| ERAS and 5 Lung Protective Interventions | Inspiratory Capacity | Postoperative incentive spirometry 1 h (average) | 1,387.3 mL | Standard Deviation 975.3 |
| ERAS and 5 Lung Protective Interventions | Inspiratory Capacity | Postoperative incentive spirometry 30 min (average) | 1,233.3 mL | Standard Deviation 894.1 |
| ERAS and 5 Lung Protective Interventions | Inspiratory Capacity | Postoperative incentive spirometry total (average) | 1,390.4 mL | Standard Deviation 964.9 |
Secondary
Incidence of Supplemental Oxygen Requirements
Recording of use or lack thereof of supplemental oxygen in PACU in 15 minute intervals.
Time frame: 2 hours
Population: 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.
Secondary
Oxygen Saturation (SPO2) Trends
Numerical value for SPO2 trends in 15 min intervals in the Post Operative Care Unit (PACU)
Time frame: 2 hours
Population: 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.