Trial Outcomes & Findings for 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 NCT04411186)
NCT ID: NCT04411186
Last Updated: 2024-07-05
Results Overview
The primary outcome of interest is the inspiratory capacity obtained in the PACU via the incentive spirometer.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
100 participants
Primary outcome timeframe
2 hours
Results posted on
2024-07-05
Participant Flow
Participant milestones
| Measure |
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.
|
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%
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
50
|
|
Overall Study
COMPLETED
|
50
|
49
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
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.
|
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%
|
|---|---|---|
|
Overall Study
Withdrawn due to protocol violation
|
0
|
1
|
Baseline Characteristics
A Trial of Adding Lung Protective Strategies to Existing Enhanced Recovery After Surgery (ERAS) Protocols and Its Effects on Improving Post-Operative Lung Function
Baseline characteristics by cohort
| Measure |
Standard Enhanced Recovery After Surgery (ERAS) Protocol
n=50 Participants
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.
|
ERAS and 5 Lung Protective Interventions
n=49 Participants
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%
|
Total
n=99 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Customized
≤ 30 years
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Age, Customized
31-50 years
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Age, Customized
51-70 years
|
28 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Age, Customized
≥ 71 years
|
11 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
50 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
99 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
42 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
82 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Body Mass Index (BMI)
Underweight (<18.5)
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Body Mass Index (BMI)
Normal ((≥ 18.5, < 25)
|
14 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Body Mass Index (BMI)
Overweight (≥ 25, < 30)
|
19 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Body Mass Index (BMI)
Obese (≥ 30)
|
15 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 hoursThe primary outcome of interest is the inspiratory capacity obtained in the PACU via the incentive spirometer.
Outcome measures
| Measure |
Standard Enhanced Recovery After Surgery (ERAS) Protocol
n=50 Participants
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.
|
ERAS and 5 Lung Protective Interventions
n=49 Participants
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%
|
|---|---|---|
|
Inspiratory Capacity
Preoperative incentive spirometry (average)
|
2,043.3 mL
Standard Deviation 628.4
|
2,012.2 mL
Standard Deviation 895.2
|
|
Inspiratory Capacity
Postoperative incentive spirometry 30 min (average)
|
1,195.2 mL
Standard Deviation 715.0
|
1,233.3 mL
Standard Deviation 894.1
|
|
Inspiratory Capacity
Postoperative incentive spirometry 1 h (average)
|
1,313.9 mL
Standard Deviation 618.1
|
1,387.3 mL
Standard Deviation 975.3
|
|
Inspiratory Capacity
Postoperative incentive spirometry 2 h (average)
|
1,376.3 mL
Standard Deviation 651.2
|
1,454.8 mL
Standard Deviation 906.4
|
|
Inspiratory Capacity
Postoperative incentive spirometry total (average)
|
1,253.5 mL
Standard Deviation 593.7
|
1,390.4 mL
Standard Deviation 964.9
|
SECONDARY outcome
Timeframe: 2 hoursPopulation: 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.
Numerical value for SPO2 trends in 15 min intervals in the Post Operative Care Unit (PACU)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 hoursPopulation: 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.
Recording of use or lack thereof of supplemental oxygen in PACU in 15 minute intervals.
Outcome measures
Outcome data not reported
Adverse Events
Standard Enhanced Recovery After Surgery (ERAS) Protocol
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
ERAS and 5 Lung Protective Interventions
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. David Gutman, M.D., MBA, Associate Professor of Anesthesiology
Medical University of South Carolina
Phone: 843-792-5454
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place