Gastric UltrasoundNCT07537582
Does Pre-operative Gastric Ultrasound Influence Anaesthetic Decision-Making in Chronic Pain Patients? A Prospective Observational Cohort.
An observational study of Gastric Ultrasound and Gastric Ultrasound in Chronic Opioid Use (≥2 Weeks), run by Danat Al Emarat Hospital at 1 site in United Arab Emirates.
Trial summary
Gastric POCUS has been validated and shown to be an accurate diagnostic tool in both healthy individuals and medically complex patient populations. Regional anaesthesiologists and pain management physicians frequently provide sedation or anaesthetic care for medically complex patients who fall outside the limited… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Ultrasound, Gastric Ultrasound in Chronic Opioid Use (≥2 Weeks), Gastric Ultrasound in Poorly Controlled Acute-on-chronic Pain
- How many people
- 140 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- Apr 2026to Aug 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This will be a single-center, prospective observational cohort study conducted at Danat Al Emarat Hospital, Abu Dhabi, UAE. Adult patients scheduled for elective chronic pain interventional procedures under procedural sedation will be screened for eligibility.
Inclusion Criteria: Patients were eligible for inclusion if they met all of the following criteria:
- Age ≥18 years
- Scheduled for elective chronic pain interventional procedures under procedural sedation
- Adherence to standard preoperative fasting guidelines (≥6 hours for clear fluids and ≥8 hours for solids)
- Presence of at least one clinical factor associated with delayed gastric emptying or increased risk of pulmonary aspiration, including:
- Chronic opioid use (≥2 weeks)
- Acute opioid administration within 24 hours prior to the procedure
- Poorly controlled acute-on-chronic pain
- Diabetes mellitus without established autonomic neuropathy
- Symptoms of gastroesophageal reflux
- Reduced functional mobility
- ASA physical status II-III
Exclusion Criteria: Patients will be excluded if any of the following present:
- Age <18 years
- Previous gastric or esophageal surgery
- Known pregnancy
- Known hiatal hernia
- Severe neurological disorders affecting swallowing or gastric motility
- Established autonomic neuropathy affecting gastric emptying (e.g. advanced diabetic gastroparesis)
- Morbid obesity (body mass index ≥35 kg·m-²), due to known limitations in gastric ultrasound image acquisition and reduced validity of volume estimation models
- Inability to provide informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
JINAN JAMEEL AL ALOOSI, CONSULTANT ANESTHESIOLOGIST contact
United Arab Emirates1 site
Danat Al Emarat Women & Children Hospital
Abu Dhabi, Abu Dhabi Emirate
JINAN JAMEEL AL ALOOSI, Consultant Anesthesiologist, +971507291195, jinan.jameel@danatalemarat.ae
Waleed Riad, Pain medicine Anesthesiologist, +971525773423, waleed.riad@danatalemarat.ae
About this study
Official title: Does Pre-operative Gastric Ultrasound Influence Anaesthetic Decision-Making in Chronic Pain Patients? A Prospective Observational Cohort Study
Gastric POCUS has been validated and shown to be an accurate diagnostic tool in both healthy individuals and medically complex patient populations. Regional anaesthesiologists and pain management physicians frequently provide sedation or anaesthetic care for medically complex patients who fall outside the limited applicability of existing fasting guidelines, including patients with chronic pain, poor acute-on-chronic pain control, and those receiving acute or chronic opioid therapy. These patients are at risk of delayed gastric emptying and may therefore benefit from additional pre-procedural assessment using gastric ultrasound prior to elective interventions
Read the detailed description
This study is the first prospective evaluation of gastric ultrasound in this high-risk, understudied population, incorporating quantitative opioid exposure and focusing on its impact on real-time anaesthetic decision-making. By linking gastric ultrasound findings to changes in peri-procedural management, this work extends gastric POCUS from a diagnostic tool to a clinically actionable risk-stratification strategy.
The aim of this study is to determine whether pre-operative gastric POCUS provides decision-relevant information that influences peri-operative aspiration risk assessment and leads to modification of pre-defined anaesthetic management plans in chronic pain patients undergoing elective interventional procedures under sedation.
Pre-procedural gastric ultrasound will be performed immediately before initiation of sedation by the investigators experienced in gastric point-of-care ultrasound, each having completed at least 30 supervised examinations. A standardised scanning protocol was used. Qualitative assessment of gastric contents was performed in the supine position and in the right lateral decubitus position. When patient-related factors precluded these positions, scanning was performed in a semi-recumbent position at approximately 45°.
Gastric contents will be classified qualitatively as:
- Empty
- Fluid (homogeneous hypoechoic contents)
- Solid or mixed (heterogeneous contents with echogenic material) When fluid content was identified, the gastric antral cross-sectional area (CSA) was measured at rest in a parasagittal plane at the level of the abdominal aorta using the serosal tracing method, as previously described. Gastric fluid volume was estimated using the validated Perlas mathematical model.
In accordance with current literature and consensus recommendations, patients with solid or mixed gastric contents were classified as having a high aspiration risk. For patients with fluid contents, a gastric volume threshold of >1.5 ml·kg-¹ body weight was used to define high aspiration risk. Patients with an empty stomach or fluid volumes ≤1.5 ml·kg-¹ were classified as low risk.
Following completion of gastric ultrasound and prior to initiation of sedation, the responsible anaesthetist reassessed the patient's aspiration risk incorporating the ultrasound findings. The anaesthetist documented whether the original anaesthetic management plan was:
- Unchanged
- Modified to a more conservative approach (additional measures to reduce aspiration risk)
- Modified to a more liberal approach Anaesthetic management modifications were made at the discretion of the responsible anaesthesiologist to ensure patient safety. The anesthesiologist responsible for patient care will not be blinded to ultrasound findings, consistent with the observational nature of the study.
- Conditions
- Gastric Ultrasound, Gastric Ultrasound in Chronic Opioid Use (≥2 Weeks), Gastric Ultrasound in Poorly Controlled Acute-on-chronic Pain, Gastric Ultrasound in Acute Opioid Administration Within 24 Hours Prior to the Procedure, Gastric Ultrasound in Diabetes Mellitus Without Established Autonomic Neuropathy, Gastric Ultrasound in Patient With Symptoms of Gastroesophageal Reflux
- Keywords
- Gastric Ultrasound for patients with chronic pain undergoing interventional procedures under sedation, Gastric Ultrasound, Patients with chronic pain
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients in whom pre-procedural gastric ultrasound resulted in a change to the pre-defined anesthetic management plan.
The Percentage of patients from the total number of patients involved in the study, in whom pre-procedural gastric ultrasound reveals signs of high aspiration risk which needed a change to the pre-defined anesthetic management plan, A management change was defined as any deviation from the originally documented sedation or airway strategy following review of ultrasound findings. (Patients with solid or mixed gastric contents, or fluid contents with a gastric volume of >1.5 ml·kg-¹ body weight are classified as having a high aspiration risk).
Measured: 1- 2 hours
Secondary outcomes (3)
Prevalence of high-risk gastric contents despite adherence to fasting guidelines
Prevalence of number of patients in our study who were fasting in accordance with fasting guidelines, and in whom pre-procedural gastric ultrasound reveals solid / mixed gastric contents or a fluid content, with a gastric volume of >1.5 ml·kg-¹ body weight, which used to define a high aspiration risk.
Measured: 1- 2 hours
Associations between gastric ultrasound findings and patient-related factors, including opioid use and comorbidities
To point out the effect and relation of each of the risk factors included in our study (e.g. Opioid use and comorbidities in chronic pain patients), on gastric contents \& volume, in the studied patients after fasting period in accordance with fasting guidelines.
Measured: 1-2 hours
Qualitative and quantitative gastric ultrasound findings
To describe the gastric ultrasound finding; Gastric contents will be classified qualitatively as; Empty, Fluid (homogeneous hypoechoic contents), Solid or mixed (heterogeneous contents with echogenic material).
Qualitative findings: When fluid content is identified, the gastric antral cross-sectional area (CSA) is measured at rest in a parasagittal plane at the level of the abdominal aorta. Gastric fluid volume is estimated using the validated Perlas mathematical model.
Measured: 1-2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2026
- Study startApr 2026 (estimated)
- Primary completionApr 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Gastric UltrasoundStudies of the same condition, open and under way.
- 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
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Danat Al Emarat Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JINAN AHMED JAMEEL AL ALOOSI, Danat Al Emarat Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07537582
- Sponsor's protocol ID
- RPDAE/2026/102
- Status last verified
- Apr 2026
- First submitted
- 12 Mar 2026
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gola W, Domagala M, Cugowski A. Ultrasound assessment of gastric emptying and the risk of aspiration of gastric contents in the perioperative period. Anaesthesiol Intensive Ther. 2018;50(4):297-302. doi: 10.5603/AIT.a2018.0029. Epub 2018 Sep 17.
PubMed 30221339Charlesworth M, Wiles MD. Pre-operative gastric ultrasound - should we look inside Schrodinger's gut? Anaesthesia. 2019 Jan;74(1):109-112. doi: 10.1111/anae.14516. No abstract available.
PubMed 30511749Pan X, Chai J, Gao X, Li S, Liu J, Li L, Li Y, Li Z. Diagnostic performance of ultrasound in the assessment of gastric contents: a meta-analysis and systematic review. Insights Imaging. 2024 Mar 27;15(1):98. doi: 10.1186/s13244-024-01665-0.
PubMed 38536581Haskins SC, Kruisselbrink R, Boublik J, Wu CL, Perlas A. Gastric Ultrasound for the Regional Anesthesiologist and Pain Specialist. Reg Anesth Pain Med. 2018 Oct;43(7):689-698. doi: 10.1097/AAP.0000000000000846.
PubMed 30052550Perlas A, Van de Putte P, Van Houwe P, Chan VW. I-AIM framework for point-of-care gastric ultrasound. Br J Anaesth. 2016 Jan;116(1):7-11. doi: 10.1093/bja/aev113. Epub 2015 May 7. No abstract available.
PubMed 25951832Kruisselbrink R, Gharapetian A, Chaparro LE, Ami N, Richler D, Chan VWS, Perlas A. Diagnostic Accuracy of Point-of-Care Gastric Ultrasound. Anesth Analg. 2019 Jan;128(1):89-95. doi: 10.1213/ANE.0000000000003372.
PubMed 29624530Perlas A, Chan VW, Lupu CM, Mitsakakis N, Hanbidge A. Ultrasound assessment of gastric content and volume. Anesthesiology. 2009 Jul;111(1):82-9. doi: 10.1097/ALN.0b013e3181a97250.
PubMed 19512861Bouvet L, Mazoit JX, Chassard D, Allaouchiche B, Boselli E, Benhamou D. Clinical assessment of the ultrasonographic measurement of antral area for estimating preoperative gastric content and volume. Anesthesiology. 2011 May;114(5):1086-92. doi: 10.1097/ALN.0b013e31820dee48.
PubMed 21364462Perlas A, Mitsakakis N, Liu L, Cino M, Haldipur N, Davis L, Cubillos J, Chan V. Validation of a mathematical model for ultrasound assessment of gastric volume by gastroscopic examination. Anesth Analg. 2013 Feb;116(2):357-63. doi: 10.1213/ANE.0b013e318274fc19. Epub 2013 Jan 9.
PubMed 23302981
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Pre-operative Gastric Ultrasound Influence Anaesthetic Decision-Making in Chronic Pain Patients? A Prospective Observational Cohort Study
- ClinicalTrials.gov ID
- NCT07537582
- Acronym / sponsor ID
- RPDAE/2026/102
- Conditions
- Gastric Ultrasound, Gastric Ultrasound in Chronic Opioid Use (≥2 Weeks), Gastric Ultrasound in Poorly Controlled Acute-on-chronic Pain, Gastric Ultrasound in Acute Opioid Administration Within 24 Hours Prior to the Procedure, Gastric Ultrasound in Diabetes Mellitus Without Established Autonomic Neuropathy, Gastric Ultrasound in Patient With Symptoms of Gastroesophageal Reflux
- Keywords
- Gastric Ultrasound for patients with chronic pain undergoing interventional procedures under sedation, Gastric Ultrasound, Patients with chronic pain
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Danat Al Emarat HospitalUniversity, hospital or other
- Study start
- Apr 2026 (estimated)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 17 Apr 2026 (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.
Gastric POCUS has been validated and shown to be an accurate diagnostic tool in both healthy individuals and medically complex patient populations. Regional anaesthesiologists and pain management physicians frequently provide sedation or anaesthetic care for medically complex patients who fall outside the limited applicability of existing fasting guidelines, including patients with chronic pain, poor acute-on-chronic pain control, and those receiving acute or chronic opioid therapy. These patients are at risk of delayed gastric emptying and may therefore benefit from additional pre-procedural assessment using gastric ultrasound prior to elective interventions
Detailed description
This study is the first prospective evaluation of gastric ultrasound in this high-risk, understudied population, incorporating quantitative opioid exposure and focusing on its impact on real-time anaesthetic decision-making. By linking gastric ultrasound findings to changes in peri-procedural management, this work extends gastric POCUS from a diagnostic tool to a clinically actionable risk-stratification strategy.
The aim of this study is to determine whether pre-operative gastric POCUS provides decision-relevant information that influences peri-operative aspiration risk assessment and leads to modification of pre-defined anaesthetic management plans in chronic pain patients undergoing elective interventional procedures under sedation.
Pre-procedural gastric ultrasound will be performed immediately before initiation of sedation by the investigators experienced in gastric point-of-care ultrasound, each having completed at least 30 supervised examinations. A standardised scanning protocol was used. Qualitative assessment of gastric contents was performed in the supine position and in the right lateral decubitus position. When patient-related factors precluded these positions, scanning was performed in a semi-recumbent position at approximately 45°.
Gastric contents will be classified qualitatively as:
- Empty
- Fluid (homogeneous hypoechoic contents)
- Solid or mixed (heterogeneous contents with echogenic material) When fluid content was identified, the gastric antral cross-sectional area (CSA) was measured at rest in a parasagittal plane at the level of the abdominal aorta using the serosal tracing method, as previously described. Gastric fluid volume was estimated using the validated Perlas mathematical model.
In accordance with current literature and consensus recommendations, patients with solid or mixed gastric contents were classified as having a high aspiration risk. For patients with fluid contents, a gastric volume threshold of >1.5 ml·kg-¹ body weight was used to define high aspiration risk. Patients with an empty stomach or fluid volumes ≤1.5 ml·kg-¹ were classified as low risk.
Following completion of gastric ultrasound and prior to initiation of sedation, the responsible anaesthetist reassessed the patient's aspiration risk incorporating the ultrasound findings. The anaesthetist documented whether the original anaesthetic management plan was:
- Unchanged
- Modified to a more conservative approach (additional measures to reduce aspiration risk)
- Modified to a more liberal approach Anaesthetic management modifications were made at the discretion of the responsible anaesthesiologist to ensure patient safety. The anesthesiologist responsible for patient care will not be blinded to ultrasound findings, consistent with the observational nature of the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This will be a single-center, prospective observational cohort study conducted at Danat Al Emarat Hospital, Abu Dhabi, UAE. Adult patients scheduled for elective chronic pain interventional procedures under procedural sedation will be screened for eligibility.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The proportion of patients in whom pre-procedural gastric ultrasound resulted in a change to the pre-defined anesthetic management plan.
Time frame: 1- 2 hours
The Percentage of patients from the total number of patients involved in the study, in whom pre-procedural gastric ultrasound reveals signs of high aspiration risk which needed a change to the pre-defined anesthetic management plan, A management change was defined as any deviation from the originally documented sedation or airway strategy following review of ultrasound findings. (Patients with solid or mixed gastric contents, or fluid contents with a gastric volume of >1.5 ml·kg-¹ body weight are classified as having a high aspiration risk).
3 secondary outcomes
Prevalence of high-risk gastric contents despite adherence to fasting guidelines
Time frame: 1- 2 hours
Associations between gastric ultrasound findings and patient-related factors, including opioid use and comorbidities
Time frame: 1-2 hours
Qualitative and quantitative gastric ultrasound findings
Time frame: 1-2 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Background: PubMed 30221339Gola W, Domagala M, Cugowski A. Ultrasound assessment of gastric emptying and the risk of aspiration of gastric contents in the perioperative period. Anaesthesiol Intensive Ther. 2018;50(4):297-302. doi: 10.5603/AIT.a2018.0029. Epub 2018 Sep 17.
- Background: PubMed 30511749Charlesworth M, Wiles MD. Pre-operative gastric ultrasound - should we look inside Schrodinger's gut? Anaesthesia. 2019 Jan;74(1):109-112. doi: 10.1111/anae.14516. No abstract available.
- Background: PubMed 38536581Pan X, Chai J, Gao X, Li S, Liu J, Li L, Li Y, Li Z. Diagnostic performance of ultrasound in the assessment of gastric contents: a meta-analysis and systematic review. Insights Imaging. 2024 Mar 27;15(1):98. doi: 10.1186/s13244-024-01665-0.
- Background: PubMed 30052550Haskins SC, Kruisselbrink R, Boublik J, Wu CL, Perlas A. Gastric Ultrasound for the Regional Anesthesiologist and Pain Specialist. Reg Anesth Pain Med. 2018 Oct;43(7):689-698. doi: 10.1097/AAP.0000000000000846.
- Background: PubMed 25951832Perlas A, Van de Putte P, Van Houwe P, Chan VW. I-AIM framework for point-of-care gastric ultrasound. Br J Anaesth. 2016 Jan;116(1):7-11. doi: 10.1093/bja/aev113. Epub 2015 May 7. No abstract available.
- Background: PubMed 29624530Kruisselbrink R, Gharapetian A, Chaparro LE, Ami N, Richler D, Chan VWS, Perlas A. Diagnostic Accuracy of Point-of-Care Gastric Ultrasound. Anesth Analg. 2019 Jan;128(1):89-95. doi: 10.1213/ANE.0000000000003372.
- Background: PubMed 19512861Perlas A, Chan VW, Lupu CM, Mitsakakis N, Hanbidge A. Ultrasound assessment of gastric content and volume. Anesthesiology. 2009 Jul;111(1):82-9. doi: 10.1097/ALN.0b013e3181a97250.
- Background: PubMed 21364462Bouvet L, Mazoit JX, Chassard D, Allaouchiche B, Boselli E, Benhamou D. Clinical assessment of the ultrasonographic measurement of antral area for estimating preoperative gastric content and volume. Anesthesiology. 2011 May;114(5):1086-92. doi: 10.1097/ALN.0b013e31820dee48.
- Background: PubMed 23302981Perlas A, Mitsakakis N, Liu L, Cino M, Haldipur N, Davis L, Cubillos J, Chan V. Validation of a mathematical model for ultrasound assessment of gastric volume by gastroscopic examination. Anesth Analg. 2013 Feb;116(2):357-63. doi: 10.1213/ANE.0b013e318274fc19. Epub 2013 Jan 9.
- Individual participant dataSharing planned: No
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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.
JINAN JAMEEL AL ALOOSI, CONSULTANT ANESTHESIOLOGIST contact
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 Gastric Ultrasound and Gastric Ultrasound in Chronic Opioid Use (≥2 Weeks), run by Danat Al Emarat Hospital at 1 site in United Arab Emirates.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: opening soon, as of the sponsor's last update on 22 Apr 2026. 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 United Arab Emirates. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact JINAN JAMEEL AL ALOOSI, CONSULTANT ANESTHESIOLOGIST (+97150 7291195, jinan.jameel@danatalemarat.ae), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of patients in whom pre-procedural gastric ultrasound resulted in a change to the pre-defined anesthetic management plan. (time frame: 1- 2 hours). 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 NCT07537582, which also lists 9 linked publications.
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 22 Apr 2026.