Surgery
Conditions
Brief summary
The primary objective of this study is to evaluate gastric volume and contents as well as gall bladder size in patients scheduled for routine, urgent, and emergency surgery. The hypothesis is that patients with stress, pain and opioid administration will have delayed gastric emptying and therefore a larger gastric fluid volume than those scheduled for elective surgery. The patients who have an appropriate NPO time will have a larger gallbladder size than the patients with shorter NPO time.
Interventions
DEVICEPoint-of-Care Ultrasound
Portable ultrasonography done at the bedside.
Sponsors
Alok Moharir
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* ASA 1-3 patients aged 2-18 years of scheduled for elective, urgent, or emergent surgery under general anesthesia.
Exclusion criteria
* History of upper gastro-intestinal surgery.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Aspiration Risk Grade | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| NPO at the Time of Injury | 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. |
| NPO at the Time of Surgery | Baseline | Amount of time the patient was without food or water prior to their surgery. |
| Pre-operative Opioid Administration | Baseline | Patients who received opioids for pain control prior to surgery. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Elective Patients who are scheduled for routine outpatient surgery.
Point-of-Care Ultrasound: Portable ultrasonography done at the bedside. | 41 |
| 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. | 32 |
| Urgent Patients who are scheduled for urgent surgery - within 2 hours of admission.
Point-of-Care Ultrasound: Portable ultrasonography done at the bedside. | 27 |
| Total | 100 |
Baseline characteristics
| Characteristic | Elective | Semi-urgent | Urgent | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 41 Participants | 32 Participants | 27 Participants | 100 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 7.8 years STANDARD_DEVIATION 5.3 | 9.8 years STANDARD_DEVIATION 4.1 | 10.6 years STANDARD_DEVIATION 3.1 | 9.2 years STANDARD_DEVIATION 4.5 |
| American Society of Anesthesiologists (ASA) status | 2 units on a scale | 1 units on a scale | 2 units on a scale | 2 units on a scale |
| BMI | 19.3 kg/m2 STANDARD_DEVIATION 4.1 | 21.3 kg/m2 STANDARD_DEVIATION 4.2 | 20.8 kg/m2 STANDARD_DEVIATION 4 | 20.3 kg/m2 STANDARD_DEVIATION 4.2 |
| Race and Ethnicity Not Collected | — | — | — | 0 Participants |
| Region of Enrollment United States | 41 Participants | 32 Participants | 27 Participants | 100 Participants |
| Sex: Female, Male Female | 17 Participants | 12 Participants | 11 Participants | 40 Participants |
| Sex: Female, Male Male | 24 Participants | 20 Participants | 16 Participants | 60 Participants |
| Weight | 35.5 kilograms STANDARD_DEVIATION 16.8 | 44.1 kilograms STANDARD_DEVIATION 8 | 47.6 kilograms STANDARD_DEVIATION 17.5 | 41.5 kilograms STANDARD_DEVIATION 18 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 41 | 0 / 32 | 0 / 27 |
| other Total, other adverse events | 0 / 41 | 0 / 32 | 0 / 27 |
| serious Total, serious adverse events | 0 / 41 | 0 / 32 | 0 / 27 |
Outcome results
Primary
Aspiration Risk Grade
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)
Time frame: Baseline
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Elective | Aspiration Risk Grade | 0 | 30 Participants |
| Elective | Aspiration Risk Grade | 1 | 9 Participants |
| Elective | Aspiration Risk Grade | Solid (High risk) | 1 Participants |
| Elective | Aspiration Risk Grade | Inconclusive | 1 Participants |
| Semi-urgent | Aspiration Risk Grade | Inconclusive | 0 Participants |
| Semi-urgent | Aspiration Risk Grade | 0 | 30 Participants |
| Semi-urgent | Aspiration Risk Grade | Solid (High risk) | 0 Participants |
| Semi-urgent | Aspiration Risk Grade | 1 | 2 Participants |
| Urgent | Aspiration Risk Grade | Inconclusive | 1 Participants |
| Urgent | Aspiration Risk Grade | 1 | 6 Participants |
| Urgent | Aspiration Risk Grade | Solid (High risk) | 0 Participants |
| Urgent | Aspiration Risk Grade | 0 | 20 Participants |
Secondary
NPO at the Time of Injury
Amount of time the patient was without food or water prior to their injury. This only applies to the Semi-urgent and Urgent groups.
Time frame: Baseline
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Elective | NPO at the Time of Injury | < 8 hours | 1 Participants |
| Elective | NPO at the Time of Injury | > 8 hours | 5 Participants |
| Semi-urgent | NPO at the Time of Injury | < 8 hours | 6 Participants |
| Semi-urgent | NPO at the Time of Injury | > 8 hours | 22 Participants |
Secondary
NPO at the Time of Surgery
Amount of time the patient was without food or water prior to their surgery.
Time frame: Baseline
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Elective | NPO at the Time of Surgery | < 8 hours | 2 Participants |
| Elective | NPO at the Time of Surgery | > 8 hours | 39 Participants |
| Semi-urgent | NPO at the Time of Surgery | < 8 hours | 1 Participants |
| Semi-urgent | NPO at the Time of Surgery | > 8 hours | 31 Participants |
| Urgent | NPO at the Time of Surgery | < 8 hours | 2 Participants |
| Urgent | NPO at the Time of Surgery | > 8 hours | 25 Participants |
Secondary
Pre-operative Opioid Administration
Patients who received opioids for pain control prior to surgery.
Time frame: Baseline
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Elective | Pre-operative Opioid Administration | 0 Participants |
| Semi-urgent | Pre-operative Opioid Administration | 5 Participants |
| Urgent | Pre-operative Opioid Administration | 11 Participants |