ANZCTR - Registration

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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 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]

none

Universal Trial Number (UTN)

U1111-1281-9881

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

elective surgery

diabetic patients

Condition category

Condition code

Metabolic and Endocrine

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]

Early Detection / Screening

Comparator / control treatment

no control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

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]

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]

Recordings and measurements were made within 15 minutes before surgery

Secondary outcome [2]

fasting blood glucose

Timepoint [2]

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]

HBA1C

Timepoint [3]

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]

Creatinine

Timepoint [4]

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]

Urea

Timepoint [5]

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]

Glomerular filtration rate(GFR)

Timepoint [6]

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?

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

Turkey

State/province [1]

Izmir

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

none

Address [1]

none

Country [1]

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]

None

Name [1]

none

Address [1]

none

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

SBÜ Izmir Tepecik Egitim Arastirma Hastanesi Girisimsel Olmayan Arastirmalar Etik Kurulu

Ethics committee address [1]

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]

Turkey

Date submitted for ethics approval [1]

26/12/2019

Approval date [1]

20/11/2020

Ethics approval number [1]

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

Dr Berrak Sebil Aydin

Address

sarikorkmaz mahallesi hürriyet sokak vadi sehir konaklari 61\1 e blok daire: 5 eregli-zonguldak 67300

Country

Turkey

Phone

+905058178141

Fax

drberraksebil@gmail.com

Contact person for public queries

Name

Berrak sebil Aydin

Address

sarikorkmaz mahallesi hürriyet sokak vadi sehir konaklari 61\1 e blok daire: 5 eregli-zonguldak 67300

Country

Turkey

Phone

+905058178141

Fax

drberraksebil@gmail.com

Contact person for scientific queries

Name

Berrak sebil Aydin

Address

sarikorkmaz mahallesi hürriyet sokak vadi sehir konaklari 61\1 e blok daire: 5 eregli-zonguldak 67300

Country

Turkey

Phone

+905058178141

Fax

drberraksebil@gmail.com

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

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