Trial Outcomes & Findings for Gastric Ultrasound in Tube Fed Intubated Patients (NCT NCT04612348)
NCT ID: NCT04612348
Last Updated: 2026-07-21
Results Overview
Median volume (mL/kg) of gastric contents measured by ultrasound.
Recruitment status
COMPLETED
Target enrollment
45 participants
Primary outcome timeframe
Baseline - 5 days
Results posted on
2026-07-21
Participant Flow
Participant milestones
| Measure |
Post-pyloric
Critically ill children receiving nutrition via a nasoduodenal (ND) or nasojejunal (NJ) feeding tube.
Ultrasound: Point of care ultrasound to measure gastric contents.
|
Gastric
Critically ill children receiving nutrition via a nasogastric (NG) feeding tube.
Ultrasound: Point of care ultrasound to measure gastric contents.
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
29
|
|
Overall Study
COMPLETED
|
16
|
29
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Post-pyloric
n=16 Participants
Critically ill children receiving nutrition via a nasoduodenal (ND) or nasojejunal (NJ) feeding tube.
Ultrasound: Point of care ultrasound to measure gastric contents.
|
Gastric
n=29 Participants
Critically ill children receiving nutrition via a nasogastric (NG) feeding tube.
Ultrasound: Point of care ultrasound to measure gastric contents.
|
Total
n=45 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
16 Participants
n=16 Participants
|
29 Participants
n=29 Participants
|
45 Participants
n=45 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=16 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=45 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=16 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=45 Participants
|
|
Age, Continuous
|
12 months
n=16 Participants
|
4 months
n=29 Participants
|
6 months
n=45 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=16 Participants
|
7 Participants
n=29 Participants
|
13 Participants
n=45 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=16 Participants
|
22 Participants
n=29 Participants
|
32 Participants
n=45 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
16 participants
n=16 Participants
|
29 participants
n=29 Participants
|
45 participants
n=45 Participants
|
|
Weight
|
10.1 kilograms
n=16 Participants
|
7.6 kilograms
n=29 Participants
|
7.9 kilograms
n=45 Participants
|
|
Height
|
76.1 centimeters
n=16 Participants
|
60 centimeters
n=29 Participants
|
62 centimeters
n=45 Participants
|
|
PRISM
Low risk
|
8 Participants
n=16 Participants
|
21 Participants
n=29 Participants
|
29 Participants
n=45 Participants
|
|
PRISM
Moderate risk
|
6 Participants
n=16 Participants
|
5 Participants
n=29 Participants
|
11 Participants
n=45 Participants
|
|
PRISM
Unknown
|
2 Participants
n=16 Participants
|
3 Participants
n=29 Participants
|
5 Participants
n=45 Participants
|
PRIMARY outcome
Timeframe: Baseline - 5 daysMedian volume (mL/kg) of gastric contents measured by ultrasound.
Outcome measures
| Measure |
Post-pyloric
n=16 Participants
Critically ill children receiving nutrition via a nasoduodenal (ND) or nasojejunal (NJ) feeding tube.
Ultrasound: Point of care ultrasound to measure gastric contents.
|
Gastric
n=29 Participants
Critically ill children receiving nutrition via a nasogastric (NG) feeding tube.
Ultrasound: Point of care ultrasound to measure gastric contents.
|
|---|---|---|
|
Average Gastric Volume
|
2.1 milliters per killogram
Interval 1.1 to 4.5
|
0 milliters per killogram
Interval 0.0 to 0.1
|
SECONDARY outcome
Timeframe: Baseline - 5 daysThe potential risk of aspirating stomach contents if patient underwent intubation.
Outcome measures
| Measure |
Post-pyloric
n=16 Participants
Critically ill children receiving nutrition via a nasoduodenal (ND) or nasojejunal (NJ) feeding tube.
Ultrasound: Point of care ultrasound to measure gastric contents.
|
Gastric
n=29 Participants
Critically ill children receiving nutrition via a nasogastric (NG) feeding tube.
Ultrasound: Point of care ultrasound to measure gastric contents.
|
|---|---|---|
|
Risk of Aspiration
Low risk
|
16 Participants
|
3 Participants
|
|
Risk of Aspiration
High risk
|
0 Participants
|
26 Participants
|
Adverse Events
Post-pyloric
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Gastric
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place