Trial Outcomes & Findings for Residual Gastric Volume Measured by Ultrasound in Diabetic Surgical Population Versus Non-diabetic Surgical Population. (NCT NCT05435157)
NCT ID: NCT05435157
Last Updated: 2026-05-01
Results Overview
Residual gastric volume measured by ultrasounds as follows: Volume (mL) = 27.0 + 14.6 × CSARLD (cm²) - 1.28 × age (years)
Recruitment status
COMPLETED
Target enrollment
592 participants
Primary outcome timeframe
Preoperative
Results posted on
2026-05-01
Participant Flow
Participant milestones
| Measure |
Diabetic Patients
Diabetic patients undergoing scheduled surgery
|
Non-diabetic Patients
Non-diabetic patients undergoing sheduled surgery
|
Diabetic Patients With Dysautonomia
Diabetic patients with dysautonomia undergoing surgery
|
|---|---|---|---|
|
Overall Study
STARTED
|
218
|
152
|
222
|
|
Overall Study
COMPLETED
|
216
|
144
|
221
|
|
Overall Study
NOT COMPLETED
|
2
|
8
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Residual Gastric Volume Measured by Ultrasound in Diabetic Surgical Population Versus Non-diabetic Surgical Population.
Baseline characteristics by cohort
| Measure |
Diabetic Patients
n=216 Participants
Diabetic patients undergoing scheduled surgery
|
Non-diabetic Patients
n=144 Participants
Non-diabetic patients undergoing sheduled surgery
|
Diabetic Patients With Dysautonomia
n=221 Participants
Diabetic patients with dysautonomia undergoing scheduled surgery
|
Total
n=581 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
70 years
n=14 Participants
|
59 years
n=34 Participants
|
72 years
n=69 Participants
|
66 years
n=140 Participants
|
|
Sex: Female, Male
Female
|
83 Participants
n=14 Participants
|
75 Participants
n=34 Participants
|
80 Participants
n=69 Participants
|
238 Participants
n=140 Participants
|
|
Sex: Female, Male
Male
|
133 Participants
n=14 Participants
|
69 Participants
n=34 Participants
|
141 Participants
n=69 Participants
|
343 Participants
n=140 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
216 Participants
n=14 Participants
|
144 Participants
n=34 Participants
|
221 Participants
n=69 Participants
|
581 Participants
n=140 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=14 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=69 Participants
|
0 Participants
n=140 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=14 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=69 Participants
|
0 Participants
n=140 Participants
|
PRIMARY outcome
Timeframe: PreoperativeResidual gastric volume measured by ultrasounds as follows: Volume (mL) = 27.0 + 14.6 × CSARLD (cm²) - 1.28 × age (years)
Outcome measures
| Measure |
Diabetic Patients
n=216 Participants
Diabetic patients undergoing scheduled surgery
|
Non-diabetic Patients
n=144 Participants
Non-diabetic patients undergoing sheduled surgery
|
Diabetic Patients With Dysautonomia
n=221 Participants
Diabetic patients with dysautonomia undergoing surgery
|
|---|---|---|---|
|
Residual Gastric Volume
|
22.1 mL
Interval -0.08 to 47.32
|
33.1 mL
Interval 9.8 to 67.1
|
40.2 mL
Interval 12.3 to 80.9
|
SECONDARY outcome
Timeframe: PreoperativeAntral cross-sectional area measured by ultrasounds
Outcome measures
| Measure |
Diabetic Patients
n=216 Participants
Diabetic patients undergoing scheduled surgery
|
Non-diabetic Patients
n=144 Participants
Non-diabetic patients undergoing sheduled surgery
|
Diabetic Patients With Dysautonomia
n=221 Participants
Diabetic patients with dysautonomia undergoing surgery
|
|---|---|---|---|
|
Antral Cross-Sectional Area
|
5.7 cm2
Interval 4.1 to 7.1
|
5.4 cm2
Interval 4.0 to 7.2
|
7.1 cm2
Interval 5.2 to 9.3
|
Adverse Events
Diabetic Patients
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Non-diabetic Patients
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Diabetic Patients With Dysautonomia
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. José A. Sastre
Hospital Universitario de Salamanca
Phone: 0034923291100
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place