Trial Outcomes & Findings for Gastric Ultrasound (NCT NCT04127331)

NCT ID: NCT04127331

Last Updated: 2023-11-21

Results Overview

Grade 0: No fluid visible in the gastric antrum Grade 1: Clear fluid visualized with volume \< 1.5 mL/kg Grade 2: Clear fluid visualized with volume \> 1.5 mL/kg (High risk of aspiration)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 100 participants
• Primary outcome timeframe: Baseline
• Results posted on: 2023-11-21

Participant Flow

Participant milestones

Measure	Elective Patients who are scheduled for routine outpatient surgery. Point-of-Care Ultrasound: Portable ultrasonography done at the bedside.	Semi-urgent Patients who are scheduled for semi-urgent surgery - within 6 hours of admission. Point-of-Care Ultrasound: Portable ultrasonography done at the bedside.	Urgent Patients who are scheduled for urgent surgery - within 2 hours of admission. Point-of-Care Ultrasound: Portable ultrasonography done at the bedside.
Overall Study STARTED	41	32	27
Overall Study COMPLETED	41	32	27
Overall Study NOT COMPLETED	0	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	Elective n=41 Participants Patients who are scheduled for routine outpatient surgery. Point-of-Care Ultrasound: Portable ultrasonography done at the bedside.	Semi-urgent n=32 Participants Patients who are scheduled for semi-urgent surgery - within 6 hours of admission. Point-of-Care Ultrasound: Portable ultrasonography done at the bedside.	Urgent n=27 Participants Patients who are scheduled for urgent surgery - within 2 hours of admission. Point-of-Care Ultrasound: Portable ultrasonography done at the bedside.	Total n=100 Participants Total of all reporting groups
Age, Categorical <=18 years	41 Participants n=41 Participants	32 Participants n=32 Participants	27 Participants n=27 Participants	100 Participants n=100 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=41 Participants	0 Participants n=32 Participants	0 Participants n=27 Participants	0 Participants n=100 Participants
Age, Categorical >=65 years	0 Participants n=41 Participants	0 Participants n=32 Participants	0 Participants n=27 Participants	0 Participants n=100 Participants
Age, Continuous	7.8 years STANDARD_DEVIATION 5.3 • n=41 Participants	9.8 years STANDARD_DEVIATION 4.1 • n=32 Participants	10.6 years STANDARD_DEVIATION 3.1 • n=27 Participants	9.2 years STANDARD_DEVIATION 4.5 • n=100 Participants
Sex: Female, Male Female	17 Participants n=41 Participants	12 Participants n=32 Participants	11 Participants n=27 Participants	40 Participants n=100 Participants
Sex: Female, Male Male	24 Participants n=41 Participants	20 Participants n=32 Participants	16 Participants n=27 Participants	60 Participants n=100 Participants
Race and Ethnicity Not Collected	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	41 Participants n=41 Participants	32 Participants n=32 Participants	27 Participants n=27 Participants	100 Participants n=100 Participants
Weight	35.5 kilograms STANDARD_DEVIATION 16.8 • n=41 Participants	44.1 kilograms STANDARD_DEVIATION 8 • n=32 Participants	47.6 kilograms STANDARD_DEVIATION 17.5 • n=27 Participants	41.5 kilograms STANDARD_DEVIATION 18 • n=100 Participants
BMI	19.3 kg/m2 STANDARD_DEVIATION 4.1 • n=41 Participants	21.3 kg/m2 STANDARD_DEVIATION 4.2 • n=32 Participants	20.8 kg/m2 STANDARD_DEVIATION 4 • n=27 Participants	20.3 kg/m2 STANDARD_DEVIATION 4.2 • n=100 Participants
American Society of Anesthesiologists (ASA) status	2 units on a scale n=41 Participants	1 units on a scale n=32 Participants	2 units on a scale n=27 Participants	2 units on a scale n=100 Participants

PRIMARY outcome

Timeframe: Baseline

Grade 0: No fluid visible in the gastric antrum Grade 1: Clear fluid visualized with volume < 1.5 mL/kg Grade 2: Clear fluid visualized with volume > 1.5 mL/kg (High risk of aspiration)

Outcome measures

Measure	Elective n=41 Participants Patients who are scheduled for routine outpatient surgery. Point-of-Care Ultrasound: Portable ultrasonography done at the bedside.	Semi-urgent n=32 Participants Patients who are scheduled for semi-urgent surgery - within 6 hours of admission. Point-of-Care Ultrasound: Portable ultrasonography done at the bedside.	Urgent n=27 Participants Patients who are scheduled for urgent surgery - within 2 hours of admission. Point-of-Care Ultrasound: Portable ultrasonography done at the bedside.
Aspiration Risk Grade 0	30 Participants	30 Participants	20 Participants
Aspiration Risk Grade 1	9 Participants	2 Participants	6 Participants
Aspiration Risk Grade Solid (High risk)	1 Participants	0 Participants	0 Participants
Aspiration Risk Grade Inconclusive	1 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Baseline

Amount of time the patient was without food or water prior to their injury. This only applies to the Semi-urgent and Urgent groups.

Outcome measures

Measure	Elective n=6 Participants Patients who are scheduled for routine outpatient surgery. Point-of-Care Ultrasound: Portable ultrasonography done at the bedside.	Semi-urgent n=28 Participants Patients who are scheduled for semi-urgent surgery - within 6 hours of admission. Point-of-Care Ultrasound: Portable ultrasonography done at the bedside.	Urgent Patients who are scheduled for urgent surgery - within 2 hours of admission. Point-of-Care Ultrasound: Portable ultrasonography done at the bedside.
NPO at the Time of Injury > 8 hours	5 Participants	22 Participants	—
NPO at the Time of Injury < 8 hours	1 Participants	6 Participants	—

SECONDARY outcome

Timeframe: Baseline

Amount of time the patient was without food or water prior to their surgery.

Outcome measures

Measure	Elective n=41 Participants Patients who are scheduled for routine outpatient surgery. Point-of-Care Ultrasound: Portable ultrasonography done at the bedside.	Semi-urgent n=32 Participants Patients who are scheduled for semi-urgent surgery - within 6 hours of admission. Point-of-Care Ultrasound: Portable ultrasonography done at the bedside.	Urgent n=27 Participants Patients who are scheduled for urgent surgery - within 2 hours of admission. Point-of-Care Ultrasound: Portable ultrasonography done at the bedside.
NPO at the Time of Surgery < 8 hours	2 Participants	1 Participants	2 Participants
NPO at the Time of Surgery > 8 hours	39 Participants	31 Participants	25 Participants

SECONDARY outcome

Timeframe: Baseline

Patients who received opioids for pain control prior to surgery.

Outcome measures

Measure	Elective n=41 Participants Patients who are scheduled for routine outpatient surgery. Point-of-Care Ultrasound: Portable ultrasonography done at the bedside.	Semi-urgent n=32 Participants Patients who are scheduled for semi-urgent surgery - within 6 hours of admission. Point-of-Care Ultrasound: Portable ultrasonography done at the bedside.	Urgent n=27 Participants Patients who are scheduled for urgent surgery - within 2 hours of admission. Point-of-Care Ultrasound: Portable ultrasonography done at the bedside.
Pre-operative Opioid Administration	0 Participants	5 Participants	11 Participants

Adverse Events

Elective

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Semi-urgent

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Urgent

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. Alok Moharir

Nationwide Children's Hospital

Phone: 614-722-4200

Email: alok.moharir@nationwidechildrens.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place