Role of Gastric Ultrasound in Preoperative Assessment of Gastric Volume in Diabetic Patients.
1 other identifier
observational
48
0 countries
N/A
Brief Summary
Background :An important risk factor for aspiration is gastric volume, determined in large part by gastric emptying. Unfortunately, measuring gastric volume over time is not easy, and scintigraphy has remained the gold standard technique for many years. Ultrasound has progressively emerged as a useful substitute due to its reduced cost and ease of performance Objectives:Assess whether ultrasonographic measurement of antral cross sectional area (CSA) can be used reliably for the diagnosis of risk stomach which defined by a gastric content volume at risk of clinical consequences for pulmonary aspiration (i.e., presence of solid particles and/or gastric fluid volume \>1.5 ml/kg) during the preoperative period in longstanding diabetic patients. Study population :
- -Longstanding diabetic patients (group D)
- -Non diabetic patients (group N) Study Design : Prospective observational study This study will be conducted at Kasr alainy Hospital; Faculty of Medicine, Cairo University.Patients scheduled for elective operations need General Anesthesia (GA) with endotracheal intubation in theatre of general surgery Preoperative ultrasound to assess gastric residual volume then general anesthesia induction will be Modified Rapid-sequence Induction as follow; Group (D)/(N) : propofol 2-3mg/kg and fentanyl 1 µg/Kg followed by Rocuronium 0.6-1.2 mg/kg. Suction of Gastric Contents by Nasogastric tube (18 french) will be inserted First set of analysis will be comparing preoperative US findings in 2 groups. Second set of analysis will be finding correlation between US findings and suction volume in two groups. Outcome parameters: To assess the residual gastric volume in longstanding diabetic patients compared to non diabetic patients. Sample Size ; was calculated as 48 patients (24) in each group.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Mar 2018
Shorter than P25 for all trials
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 12, 2018
CompletedFirst Posted
Study publicly available on registry
February 19, 2018
CompletedStudy Start
First participant enrolled
March 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2018
CompletedFebruary 19, 2018
February 1, 2018
3 months
February 12, 2018
February 16, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
assessment of residual gastric volume in longstanding diabetic patients
To assess the residual gastric volume in longstanding diabetic patients compared to non diabetic patients
intra-operative
Secondary Outcomes (1)
correlation between preoperative gastric US findings and fasting hours in both groups
intraoperative
Study Arms (2)
Group D
Group N
Interventions
assessment of gastric volume in Diabetic Patients
assessment of gastric volume in Non- Diabetic Patients
Eligibility Criteria
Diabetic patients with long standing diabetis ( more than 6 years) so , it may affect gastric nerve supply.
You may qualify if:
- Ages from 40 to 60 years old.
- American Society of Anesthiologist (ASA) II.
- Diabetic patients with longstanding duration(more than 6 years).
You may not qualify if:
- Age \<40,\>60 years .
- Pregnant female
- Obese patients (BMI ≤40)
- Patients with Gastric Intestinal Tract (GIT) diseases affect gastric emptying.
- Diabetic patients less than 6 years.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Related Publications (1)
Sabry R, Hasanin A, Refaat S, Abdel Raouf S, Abdallah AS, Helmy N. Evaluation of gastric residual volume in fasting diabetic patients using gastric ultrasound. Acta Anaesthesiol Scand. 2019 May;63(5):615-619. doi: 10.1111/aas.13315. Epub 2019 Jan 4.
PMID: 30609007DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Day
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Lecturer of Anesthiology
Study Record Dates
First Submitted
February 12, 2018
First Posted
February 19, 2018
Study Start
March 1, 2018
Primary Completion
June 1, 2018
Study Completion
June 1, 2018
Last Updated
February 19, 2018
Record last verified: 2018-02