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Does Pre-operative Gastric Ultrasound Influence Anaesthetic Decision-Making in Chronic Pain Patients? A Prospective Observational Cohort.

ConditionsGastric UltrasoundGastric Ultrasound in Chronic Opioid Use (≥2 Weeks)Gastric Ultrasound in Poorly Controlled Acute-on-chronic PainGastric Ultrasound in Acute Opioid Administration Within 24 Hours Prior to the ProcedureGastric Ultrasound in Diabetes Mellitus Without Established Autonomic NeuropathyGastric Ultrasound in Patient With Symptoms of Gastroesophageal RefluxGastric Ultrasound in Patients With Reduced Functional Mobility
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorDanat Al Emarat Hospital

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Chronic opioid use (≥2 weeks)

Disqualifiers

Age <18 years

Previous gastric or esophageal surgery

Known pregnancy

Known hiatal hernia

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

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).

Time frame
1- 2 hours

Secondary outcomes

1

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.

Time frame
1- 2 hours
2

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.

Time frame
1-2 hours
3

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.

Time frame
1-2 hours

Other outcomes

Sponsors and contacts

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Danat Al Emarat Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: