Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001385730
Ethics application status
Approved
Date submitted
25/08/2022
Date registered
28/10/2022
Date last updated
28/10/2022
Date data sharing statement initially provided
28/10/2022
Date results information initially provided
28/10/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Determinants of gastric residual volume before elective surgery in diabetic patients
Scientific title
Determinants of gastric residual volume before elective surgery in diabetic patients
Secondary ID [1] 307850 0
none
Universal Trial Number (UTN)
U1111-1281-9881
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
elective surgery 327461 0
diabetic patients 327462 0
Condition category
Condition code
Metabolic and Endocrine 324586 324586 0 0
Diabetes

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The patients were interviewed the night before the operation and were told to record what they ate and when. The last laboratory values of the patients registered in the system were recorded. The patients were instructed not to smoke for at least 8 hours before the measurement.Gastric antrum measurement with ultrasound was measured in the premedication chamber within the last hour before surgery. Gastric antrum measurement was performed in the premedication room by ultrasound in the supine and right lateral decubitus positions, taking into account the anatomical reference points before the patients were taken into operation.
Ultrasound evaluation training was provided by the radiology team and at least 40 patients were evaluated with gastric ultrasound.Measurements were made by a single anesthesiologist.
Measurements were made 3 times in about 15 minutes before the operation,the average was taken .
Intervention code [1] 324316 0
Early Detection / Screening
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 332406 0
Evaluation was performed using the SonoSite® M-turbo USG system with a 4 Hz curved probe (Washington, USA).
Calculation of "gastric residual volume" based on cross sectional area (CSA )measurement
Timepoint [1] 332406 0
Gastric residual volume measurement with ultrasound was performed within 15 minutes before induction of anesthesia.. Gastric antrum measurement was performed by ultrasound taking into account the anatomical reference points before the patients were taken into operation. The process from measurement to anesthesia induction is 15 minutes.
Secondary outcome [1] 413387 0
starvation time is secondary outcome. The patients were interviewed the night before the operation and were told to record what they ate and when.
Timepoint [1] 413387 0
Recordings and measurements were made within 15 minutes before surgery
Secondary outcome [2] 413805 0
fasting blood glucose
Timepoint [2] 413805 0
Fasting blood glucose levels were measured from the fingertips of the patients immediately prior to the ultrasound measurements(15 minutes before surgery)
Secondary outcome [3] 413806 0
HBA1C
Timepoint [3] 413806 0
Data were obtained from records available in the hospital system within the last month. The latest HbA1C value in the last month was obtained from records available in the hospital system
Secondary outcome [4] 413807 0
Creatinine
Timepoint [4] 413807 0
Data were obtained from records available in the hospital system within the last month .Weekly creatinin levels were obtained from records available in the hospital system within the last month
Secondary outcome [5] 413808 0
Urea
Timepoint [5] 413808 0
Data were obtained from records available in the hospital system within the last month.Weekly urea levels were obtained from records available in the hospital system within the last month
Secondary outcome [6] 413809 0
Glomerular filtration rate(GFR)
Timepoint [6] 413809 0
Data were obtained from records available in the hospital system within the last month.Weekly glomerular filtration rate levels were obtained from records available in the hospital system within the last month.

Eligibility
Key inclusion criteria
We study with patients who have Type 2 diabetes, were ASA II-III group and over 18 years of age, who scheduled for elective surgery and gave consent to participate in the study.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Having had previous GIS surgery
Acquired/congenital gastroesophageal disease
Pregnancy terminated in the current and last 3 months
Inability to obtain a suitable image with US
Uncooperative patient
Patient unable to lie flat
Premedicated patient
Use of drugs that delay gastric emptying in the last 48 hours (Tricyclic antidepressant (TCA) Proton pump inhibitor (PPI), H2 receptor antagonist) and bowel preparation

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Data analysis will be done using SPSS 22.0 program. Continuous data normal with Shapiro-Wilk test
will be evaluated in terms of distribution and, according to the distribution, the mean (standard deviation) or median (quartiles)
will be expressed as the gap. Data with normal distribution between groups were determined by t-test.
non-distribution will be tested with Mann-Whitney. For categorical data, chi-square or
Fisherexact test will be used. Independent risk factors with p <0.1 will be included in logistic regression analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
20/03/2021
Date of last participant enrolment
Anticipated
Actual
20/05/2021
Date of last data collection
Anticipated
Actual
21/05/2021
Sample size
Target
70
Accrual to date
Final
65
Recruitment outside Australia
Country [1] 24981 0
Turkey
State/province [1] 24981 0
Izmir

Funding & Sponsors
Funding source category [1] 312124 0
Self funded/Unfunded
Name [1] 312124 0
none
Country [1] 312124 0
Primary sponsor type
Individual
Name
berrak sebil aydin
Address
Hürriyet sokak sarikorkmaz mah. 61/1 e blok daire:5 vadi konak evleri.
Country
Turkey
Secondary sponsor category [1] 313646 0
None
Name [1] 313646 0
none
Address [1] 313646 0
none
Country [1] 313646 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311523 0
SBÜ Izmir Tepecik Egitim Arastirma Hastanesi Girisimsel Olmayan Arastirmalar Etik Kurulu
Ethics committee address [1] 311523 0
T.C. Saglik Bilimleri Üniversitesi
Izmir Tepecik Egitim ve Arastirma Hastanesi

GÜNEY MAHALLESI 1140/1 SOKAK NO : 1 YENISEHIR - KONAK - IZMIR, TÜRKIYE
0232 469 69 69
Ethics committee country [1] 311523 0
Turkey
Date submitted for ethics approval [1] 311523 0
26/12/2019
Approval date [1] 311523 0
20/11/2020
Ethics approval number [1] 311523 0
2019/18-39

Summary
Brief summary
In this study; it is aimed to investigate on factors affecting low and high-risk
groups in terms of aspiration by measuring gastric volume with ultrasound in
diabetic patients who fasted for elective surgery.
After obtaining written informed consent from patients with diabetes mellitus, who will undergo elective surgery, day/night before surgery.
Then, the appropriate fasting time will be explained to the patient and they will be asked to record the last meal (solid and liquid) they ate.
Detailed anamnesis was taken, demographic data in the case report form, drugs used, accompanying
diseases, duration, type and complications of diabetes will be questioned.
Fasting times on the morning of the surgery will be questioned again and recorded. Low frequency (2-5 With the MHz) curved probe, patients were first in the supine position and then in the right lateral position for five minutes. The measurement will be made by keeping it waiting.Gastric antrum will be displayed. Left lobe of liver and head of pancreas as anatomical reference points. Inferior vena cava and abdominal aorta will be taken. Qualitative and quantitative measurements will be made. Qualitative grade 0 if the antrum is small, the anterior-posterior wall is close to each other, thick and the contents are not visible; wall thin and only if clear fluid is seen in the right lateral position grade 1; wall thin and clear hypoechoic or If the anechoic fluid appears in both the supine and right lateral positions, it will be considered grade 2. Quantitative Crosssectional area (CSA) will be measured with ultrasound using the two-dimensional method.
Antrumanteroposterior (AP) and craniocaudal (CC) measurements will be made from serosa to serosa of the antrum and it will be calculated according to the formula CSA=(AP x CC x pi number)\4. Measuring 3 times CSA and its average Then, according to the PERLA formula, GV (ml)=27.0+14.6 x right lateral CSA (cm2) -1.28 x age (years) gastric residual volume will be calculated. Threshold value for gastric volume content, which will pose a risk for aspiration, is 1.5 ml/kg will be accepted. Grade 0 low risk, if we see solid food in the content, high risk, liquid food in the content grade 1 or volume < 1.5 ml\kg, low risk; Grade 2 or high risk if the volume is >1.5 ml\kg .Measurements will be taken with a US instructor prior to the study, and experience will be taken by measuring 50 times will be carried out by the researcher. The last measured FBG(fasting blood glucose) HbA1C, creatinine value by scanning the hospital computer system will be recorded. In terms of risk factors, the patients evaluated as full stomach and those evaluated as empty stomach will be compared.
Trial website
Trial related presentations / publications
Public notes
Gastric residual volume (GRV), Cross sectional area (CSA)

Contacts
Principal investigator
Name 121398 0
Dr Berrak Sebil Aydin
Address 121398 0
sarikorkmaz mahallesi hürriyet sokak vadi sehir konaklari 61\1 e blok daire: 5 eregli-zonguldak 67300
Country 121398 0
Turkey
Phone 121398 0
+905058178141
Fax 121398 0
Email 121398 0
drberraksebil@gmail.com
Contact person for public queries
Name 121399 0
Dr Berrak sebil Aydin
Address 121399 0
sarikorkmaz mahallesi hürriyet sokak vadi sehir konaklari 61\1 e blok daire: 5 eregli-zonguldak 67300
Country 121399 0
Turkey
Phone 121399 0
+905058178141
Fax 121399 0
Email 121399 0
drberraksebil@gmail.com
Contact person for scientific queries
Name 121400 0
Dr Berrak sebil Aydin
Address 121400 0
sarikorkmaz mahallesi hürriyet sokak vadi sehir konaklari 61\1 e blok daire: 5 eregli-zonguldak 67300
Country 121400 0
Turkey
Phone 121400 0
+905058178141
Fax 121400 0
Email 121400 0
drberraksebil@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
My individual data is presented below and no other participant data will be shared.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Basic resultsNo 384585-(Uploaded-25-08-2022-21-35-19)-Basic results summary.docx

Documents added automatically
No additional documents have been identified.