AspirationNCT04083677
Routine Point of Care Ultrasound (POCUS) Assessment of Antral Gastric Contents in Traumatic Surgical Patients for Prevention of Aspiration Pneumonitis
An observational study of Aspiration, run by Ain Shams University at 1 site in Egypt.
Trial summary
Pulmonary aspiration of gastric contents is uncommon in the elective, surgical populations, but highly prevalent in trauma patients who requires emergency surgery as trauma impair gastric motility and emptying.1 Presence of residual gastric volume at the time of anesthetic induction is an important risk of aspiration… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Aspiration
- What is being tested?
- SONAR
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2019to 30 Nov 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study included forty five polytrauma patients (18-65 years old of both sexes) admitted for emergency surgery.
Who may be able to join
- polytrauma patients admitted for emergency surgery.
Who cannot join
- patients with obesity (BMI> 35kg/m2),
- pregnancy,
- a history of upper gastrointestinal diseases including gastroesophageal reflux disease, hiatus hernia, gastroeosphgeal cancer or upper GIT surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Lecturer of Anesthesia
Pulmonary aspiration of gastric contents is uncommon in the elective, surgical populations, but highly prevalent in trauma patients who requires emergency surgery as trauma impair gastric motility and emptying.1 Presence of residual gastric volume at the time of anesthetic induction is an important risk of aspiration pneumonitis.2 Routine use of non-invasive bedside ultrasound gives information about the volume and nature of gastric volume. Determination of gastric content volume preoperatively will help the anesthetist in the assessment of pulmonary aspiration risk 3, 4 Ultrasongraphic measurment of antral CSA (cross sectional area) can diagnose risk stomach during the preoperative period defined by a gastric volume at risk of pulmonary aspiration (ie presence of Solid particles and/or gastric volume >1.5 ml/kg)5 The aim of our study is to allow routine use of point of care ultrasound (pocus) of gastric contents in order to inform an assessment of aspiration risk and guide anesthetic mangment
Read the detailed description
A prospective randomized study will be conducted in Ain Shams University Hospital-Emergency Department. Institutional Research Ethics Committee approval will be obtained and written informed consent will be obtained from all participants before enrollment. The study included forty five polytrauma patients (18-65 years old of both sexes) admitted for emergency surgery.
On admission, ABC protocol will be applied, (GCS) Glasgow coma scale assessment, complete laboratory investigations and radiology and complete clinical examination with assessment of fasting hours.
Exclusion criteria are patients with obesity (BMI> 35kg/m2), pregnancy, a history of upper gastrointestinal diseases including gastroesophageal reflux disease, hiatus hernia, gastroeosphgeal cancer or upper GIT surgery.
A curved low- frequency (2-5 MHZ) probe and (simens ACUSON x 300) ultrasound system will be used. All patient will be first scanned in the supine position, followed by the right lateral decubitus (RLD) position. The gastric antrum was identified in a sagittal scanning plane in the epigastrium immediately inferior to xiphoid and superior to umbilicus. The liver anteriorly and the aorta, inferior vena cava and pancreas posteriorly were used as anatomical reference points.
Fig. (1): Sagittal/parasgittal scanning plane for gastric assessment
Fig. (2) A Sagittal sonogram of the gastric antrum. A = antrum; L = liver; P = pancreas; SMA = superior mesenteric artery; Ao = aorta. B Schematic representation of sagittal sonoanatomy. A = antrum; L = liver; P = pancreas; SMA = superior mesenteric artery; Ao = aorta
The "empty" antrum appeared collapsed and "flat" with the anterior and posterior walls very close to each other or round to ovoid in shape resembling a "bull's eye" target.
The antrum appeared distended with a round shape when filled with a clear fluid. Multiple gas "bubbles" appeared as punctuate hyperechoic areas within the hypoechoic fluid, mimicking a "starry night" appearance.
The antrum appeared distended with a contents of mixed echogenicity when filled with a solid contents give the antrum "frosted glass" appearance.
When the stomach contains clear fluid, a volume assessment can help differentiate a negligible volume consistent with baseline secretions vs a higher than baseline volume. So, the antral cross sectional area (CSA) was calculated after measuring the two dimensions of the antrum (D1 an D2) according to the following equation: π (D1 x D2)/4 and the volume of clear fluid was calculated using a cross- sectional area CSA of the antrum measured in the RLD and a previously published mathematical model: volume (ml)= 27.0+(14.3 x Right - lat (CSA) - (1.25 x age). This equation accurately predicts gastric volume up to 500 ml.
Nasogastric ryle will be inserted (if there is no contraindication) to confirm gastric ultrasound volume calculation.
Additionally, the antrum as classified according to a 3-point grading system (perlas grade 0-2) that is based on the absence or presence of clear fluid in the supine and RLD positions. Grade 0 refers to the absence of gastric content in the antrum in both supine and RLD positions. Grade 1 refers to antral clear fluid that is appreciable only in the RLD. Grade 2 refers to clear fluid that is documented in both the supine and RLD positions.
Fig.(3): flow chart for interpretation of findings and medical decision- making based on gastric point of care ultrasound findings. Used with permission from gastric ultrasound. Org The low risk result will suggest that the risk of aspiration is low and it may be safe to proceed with surgery with a slowly titrated induction of anesthesia as dictated by the patient's cardiac condition using laryngeal mask or E.T.T.
The high risk result will suggest that the risk of aspiration is high, and this finding would support: 1, postponing surgrery, till completion of fasting hours 2 loco-regional anesthesia; neuraxial anesthesia, and 3, general anesthesia with rapid sequence induction, up to awake fibro-optic intubation.
We will record the incidence of change in anesthetic technique and change in timing of surgical procedure (as a primary outcome) and incidence of perioperative aspiration (as a secondary outcome) when we use gastric ultrasound preoperatively in these patients.
Sample size:
Using medical program setting alpha error at 5% \& power at 90% we calculated our sample size based on the result of (sabry et al., 2018) which showed very good correlation between gastric volume using ultrasound and volume of aspirated gastric content with an assumed (r=0.5). Based on this the needed sample is 45 cases taken in account 10% drop out rate.
- Conditions
- Aspiration
- Being tested
- SONAR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SONARDevice
A curved low- frequency (2-5 MHZ) probe and (simens ACUSON x 300) ultrasound system will be used. All patient will be first scanned in the supine position, followed by the right lateral decubitus (RLD) position. The gastric antrum was identified in a sagittal scanning plane in the epigastrium immediately inferior to xiphoid and superior to umbilicus. The liver anteriorly and the aorta, inferior vena cava and pancreas posteriorly were used as anatomical reference points.
| Study group | Role | What they receive |
|---|---|---|
| Control GROUP | healthy adult fasting 8 hours before the operation sonographic examination of gastric antrum before anesthesia Receives: Device: SONAR | |
| trauma GROUP | trauma patients fasting 8 hours before the operation sonographic examination of gastric antrum before anesthesia Receives: Device: SONAR |
What is being measured
The primary outcome is the main question the study is designed to answer.
gastric content
gastric content volume by sonar
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2019
- Study start1 Sep 2019
- Primary completion1 Oct 2019
- Study completion30 Nov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AspirationStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, RAMY AHMED, Ain Shams University
- Investigators
- ramy mahrose, md, Study director, asuh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04083677
- Sponsor's protocol ID
- Ain Shams university 11
- Status last verified
- Nov 2019
- First submitted
- 6 Sep 2019
- Last updated
- 25 Nov 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Shorbagy MS, Kasem AA, Gamal Eldin AA, Mahrose R. Routine point-of-care ultrasound (POCUS) assessment of gastric antral content in traumatic emergency surgical patients for prevention of aspiration pneumonitis: an observational clinical trial. BMC Anesthesiol. 2021 May 8;21(1):140. doi: 10.1186/s12871-021-01357-y.
PubMed 33964867
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lecturer of Anesthesia
- ClinicalTrials.gov ID
- NCT04083677
- Acronym / sponsor ID
- Ain Shams university 11
- Conditions
- Aspiration
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 1 Oct 2019 (actual)
- Study completion
- 30 Nov 2019 (estimated)
- First posted
- 10 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pulmonary aspiration of gastric contents is uncommon in the elective, surgical populations, but highly prevalent in trauma patients who requires emergency surgery as trauma impair gastric motility and emptying.1 Presence of residual gastric volume at the time of anesthetic induction is an important risk of aspiration pneumonitis.2 Routine use of non-invasive bedside ultrasound gives information about the volume and nature of gastric volume. Determination of gastric content volume preoperatively will help the anesthetist in the assessment of pulmonary aspiration risk 3, 4 Ultrasongraphic measurment of antral CSA (cross sectional area) can diagnose risk stomach during the preoperative period defined by a gastric volume at risk of pulmonary aspiration (ie presence of Solid particles and/or gastric volume >1.5 ml/kg)5 The aim of our study is to allow routine use of point of care ultrasound (pocus) of gastric contents in order to inform an assessment of aspiration risk and guide anesthetic mangment
Detailed description
A prospective randomized study will be conducted in Ain Shams University Hospital-Emergency Department. Institutional Research Ethics Committee approval will be obtained and written informed consent will be obtained from all participants before enrollment. The study included forty five polytrauma patients (18-65 years old of both sexes) admitted for emergency surgery.
On admission, ABC protocol will be applied, (GCS) Glasgow coma scale assessment, complete laboratory investigations and radiology and complete clinical examination with assessment of fasting hours.
Exclusion criteria are patients with obesity (BMI> 35kg/m2), pregnancy, a history of upper gastrointestinal diseases including gastroesophageal reflux disease, hiatus hernia, gastroeosphgeal cancer or upper GIT surgery.
A curved low- frequency (2-5 MHZ) probe and (simens ACUSON x 300) ultrasound system will be used. All patient will be first scanned in the supine position, followed by the right lateral decubitus (RLD) position. The gastric antrum was identified in a sagittal scanning plane in the epigastrium immediately inferior to xiphoid and superior to umbilicus. The liver anteriorly and the aorta, inferior vena cava and pancreas posteriorly were used as anatomical reference points.
Fig. (1): Sagittal/parasgittal scanning plane for gastric assessment
Fig. (2) A Sagittal sonogram of the gastric antrum. A = antrum; L = liver; P = pancreas; SMA = superior mesenteric artery; Ao = aorta. B Schematic representation of sagittal sonoanatomy. A = antrum; L = liver; P = pancreas; SMA = superior mesenteric artery; Ao = aorta
The "empty" antrum appeared collapsed and "flat" with the anterior and posterior walls very close to each other or round to ovoid in shape resembling a "bull's eye" target.
The antrum appeared distended with a round shape when filled with a clear fluid. Multiple gas "bubbles" appeared as punctuate hyperechoic areas within the hypoechoic fluid, mimicking a "starry night" appearance.
The antrum appeared distended with a contents of mixed echogenicity when filled with a solid contents give the antrum "frosted glass" appearance.
When the stomach contains clear fluid, a volume assessment can help differentiate a negligible volume consistent with baseline secretions vs a higher than baseline volume. So, the antral cross sectional area (CSA) was calculated after measuring the two dimensions of the antrum (D1 an D2) according to the following equation: π (D1 x D2)/4 and the volume of clear fluid was calculated using a cross- sectional area CSA of the antrum measured in the RLD and a previously published mathematical model: volume (ml)= 27.0+(14.3 x Right - lat (CSA) - (1.25 x age). This equation accurately predicts gastric volume up to 500 ml.
Nasogastric ryle will be inserted (if there is no contraindication) to confirm gastric ultrasound volume calculation.
Additionally, the antrum as classified according to a 3-point grading system (perlas grade 0-2) that is based on the absence or presence of clear fluid in the supine and RLD positions. Grade 0 refers to the absence of gastric content in the antrum in both supine and RLD positions. Grade 1 refers to antral clear fluid that is appreciable only in the RLD. Grade 2 refers to clear fluid that is documented in both the supine and RLD positions.
Fig.(3): flow chart for interpretation of findings and medical decision- making based on gastric point of care ultrasound findings. Used with permission from gastric ultrasound. Org The low risk result will suggest that the risk of aspiration is low and it may be safe to proceed with surgery with a slowly titrated induction of anesthesia as dictated by the patient's cardiac condition using laryngeal mask or E.T.T.
The high risk result will suggest that the risk of aspiration is high, and this finding would support: 1, postponing surgrery, till completion of fasting hours 2 loco-regional anesthesia; neuraxial anesthesia, and 3, general anesthesia with rapid sequence induction, up to awake fibro-optic intubation.
We will record the incidence of change in anesthetic technique and change in timing of surgical procedure (as a primary outcome) and incidence of perioperative aspiration (as a secondary outcome) when we use gastric ultrasound preoperatively in these patients.
Sample size:
Using medical program setting alpha error at 5% \& power at 90% we calculated our sample size based on the result of (sabry et al., 2018) which showed very good correlation between gastric volume using ultrasound and volume of aspirated gastric content with an assumed (r=0.5). Based on this the needed sample is 45 cases taken in account 10% drop out rate.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control GROUP | – | Device: SONARhealthy adult fasting 8 hours before the operation sonographic examination of gastric antrum before anesthesia |
| trauma GROUP | – | Device: SONARtrauma patients fasting 8 hours before the operation sonographic examination of gastric antrum before anesthesia |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study included forty five polytrauma patients (18-65 years old of both sexes) admitted for emergency surgery.
Key inclusion criteria (1 listed)
- polytrauma patients admitted for emergency surgery.
Key exclusion criteria (3 listed)
- patients with obesity (BMI> 35kg/m2),
- pregnancy,
- a history of upper gastrointestinal diseases including gastroesophageal reflux disease, hiatus hernia, gastroeosphgeal cancer or upper GIT surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SONARA curved low- frequency (2-5 MHZ) probe and (simens ACUSON x 300) ultrasound system will be used. All patient will be first scanned in the supine position, followed by the right lateral decubitus (RLD) position. The gastric antrum was identified in a sagittal scanning plane in the epigastrium immediately inferior to xiphoid and superior to umbilicus. The liver anteriorly and the aorta, inferior vena cava and pancreas posteriorly were used as anatomical reference points. | Device | Control GROUP, trauma GROUP |
Primary outcome
gastric content
Time frame: 6 months
gastric content volume by sonar
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2019.
- Derived from this study: PubMed 33964867Shorbagy MS, Kasem AA, Gamal Eldin AA, Mahrose R. Routine point-of-care ultrasound (POCUS) assessment of gastric antral content in traumatic emergency surgical patients for prevention of aspiration pneumonitis: an observational clinical trial. BMC Anesthesiol. 2021 May 8;21(1):140. doi: 10.1186/s12871-021-01357-y.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ramy mahrose, md study director
asuh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aspiration, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
gastric content (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04083677, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2019.