The Effect of Carbohydrate Loading on Gastric Residual Volume and Hunger Score

May 15, 2019 updated by: Bee Chen Lua, Universiti Sains Malaysia

The Effect of Carbohydrate Loading on Gastric Residual Volume and Hunger Score: A Single Blind, Randomised Controlled Trial Study

This study conducted is to assess effect of carbohydrate loading (maltodextrin with whey protein) to gastric volume 2 hours after ingestion via aspiration while doing OGDS (direct visualisation) and patient's wellbeing (hunger, thirst, weakness, tiredness, anxiety) for all patient planned for OGDS.

hypothesis H1: There is significant association between carbohydrate loading with residual gastric volume and subject's wellbeing H0: there is no significant association between carbohydrate loading with gastric residual volume and subject's wellbeing

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Patient scheduled for elective OGDS in HUSM from April 2019 to December 2019 with the complaint of one or more of the following symptoms: Bothersome postprandial fullness, early satiation, Epigastric pain or Epigastric burning are eligible to participate in the study. Patients who fulfilled exclusion criteria (History of upper gastrointestinal surgery, intestinal obstruction, patient with vomiting or mentally disable or who cannot give an informed consent) are ineligible.

If a patient fulfils the inclusion criteria, a suitable medical officer will discuss the trial with patient while reviewing patient in surgical outpatient clinic prior to OGDS. Patient will be approached again on the day of OGDS, if patient agree to participate in study, a written consent will be obtained. If patient refuse to participate in study, appropriate treatment and care still will be provided to patient. The consent form will provide information about the purpose of the study, the procedures to be followed, risks and benefits of participation. If patient agree to participate in the trial, subject will be enrolled in the study. Method of recruitment in this study is direct recruitment of potential study participants.

Stratified permuted block randomization was used. Randomization sequence was created using https://www.sealedenvelope.com/simple-randomiser/v1/lists and is stratified by gender (female and male) with 1:1 allocation. Random block sizes of 6 is used.

Allocation sequence is according computer generated random number list, it was prepared by an investigator with no clinical involvement in the trial. Allocation sequence was concealed from researcher enrolling and assessing participants. Allocation sequence will be sealed in sequentially numbered and opaque envelopes. A manila card will be placed inside envelop to render it impermeable to intense light. To prevent subversion of the allocation sequence, the name and I/C of the participant will be written on a book together with the series number on envelopes. The details in the book will be kept confidentially. After enrolled subject complete all baseline assessment, corresponding envelope will be enclosed by staff (who not involve in study) who prepare the drink. The staff need to ensure that the envelop still sealed when receive it. The staff will prepare the drink into identical container according to the assignment

Subjects are randomised into 2 group: group A with 250cc plain water and group B give 1 packet resource(237ml). Subjects need to finish the drink over 10minutes. After that, subjects are not allow to leave endoscope room before OGDS done to prevent consumption of other drink or food.

2 hours after that, subject undergo OGDS. OGDS is done follow standard protocol.

  1. Patient lies in left lateral position
  2. Medication to numb the back of throats (spray) will be given to prevent gagging during the passage of the instrument
  3. A plastic mouth guard is placed between the teeth to prevent damage to the teeth and endoscope.
  4. The endoscope (also called a gastroscope) will be inserted through the mouthpiece
  5. A small container or yankauer suction is placed close to the mouth of a patient to collect saliva during and after the esophagogastroduodenoscopy
  6. Endoscope will be inserted along the middle line of the soft palate.
  7. Once endoscope advanced, patient may be asked to swallow to facilitate advancement of scope.
  8. Throughout the procedure, no water flushing is allowed, only air inflation is allowed
  9. visualised pooling of fluid in the stomach is aspirated until dry via direct visualization with endoscope. Aspirated fluid will be collected in suction reservoir and the fluid will be measured.

Subject's wellbeing is assessed via visual analogue scale (VAS) which consist of 5 parameters: hunger, thirst, anxiety, tiredness and weakness. Each scale consisted of ungraded, horizontal lines anchored at two ends. The left end of the scale represented "not at all" which score: 0 and the right end represented and "the most imaginable" which score: 100. Trained staff nurse will ask patient regarding level of 5 parameters and subject need to mark X somewhere along the horizontal line given before drink and before OGDS procedure.

All subjects are advised to inform assessor if there is adverse reaction. Medical personnel are available to manage any adverse events that might occur throughout the procedure.

The possible risk that may arise in the study include injury to the gastrointestinal's wall, aspiration and bleeding which is the similar risk for all patient going through OGDS procedure. Small volume of the drink will not cause psychological distress to subject, but its taste may not be palatable.

Sample size is calculated for all the objectives. However, the one that yield the biggest number is taken as the sample size.

objective 1 is to identify the gastric residual volume between subject with plain water (group A) and carbohydrate loading (group B). Sample size was calculated using comparing two means formula.

Objective 2 is to determined patient's well being for group A and group B. sample size was calculate using comparing paired difference formula.

For all sample size calculation, type I error was set at 5% (two tailed), Type 2 error was 20% (to achieve 80% power of study).

Corrected sample size is calculated after included 10% of dropout rate. Corrected sample size = calculated sample size/ (1-anticipated drop out rate).

After considering both objective, 1st objective give biggest number of sample size. Hence, 35 subject per group with a total number of 70 subjects are needed to study both objectives. after consider dropout rate, minimum sample size in this study is 39 subjects per group with a total number of 78 subjects.

The collected data will be entry and analyzed using SPSS version 24 (SPSS Inc., Chicago, IL, USA)

Objective 1 is to determine and compare gastric residual volume between group A and group B subjects. Independent T test is used to interpret the date.

Objective 2 is to determine and compare subject's well being before and after drink in between group A and group B. paired t test is used to determine effect of drink on subject's wellbeing before and after in each group. ANOVA is used to compare effect of the drink in both groups.

Study Type

Interventional

Enrollment (Anticipated)

78

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

- Patient more than 18 years old

Exclusion Criteria:

  • History of upper gastrointestinal surgery
  • Intestinal obstruction
  • Patient with vomiting
  • Mentally disable or who cannot give an informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: plain water
subject drink 250cc plain water
Other: plain water
250ml plain water
Active Comparator: resource
subject drink 1 packet resource(237ml)
Dietary supplement: resource
1 packet resource(237ml), 1.05kcal/ml, 53.6g carbohydrate and 9g protein

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
gastric residual volume
Time Frame: 2 hours after plain water or carbohydrate loading
Amount of gastric residual volume (ml) that has been aspirated via OGDS 2 hours after plain water or carbohydrate loading group
2 hours after plain water or carbohydrate loading

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
patient's wellbeing
Time Frame: baseline (before drink) and 120minutes after drinking
Subject's wellbeing is assessed via visual analogue scale (VAS) which consist of 5 parameters: hunger, thirst, anxiety, tiredness and weakness. Each scale consisted of ungraded, horizontal lines (with length of 100mm) anchored at two ends. The left end of the scale represented "not at all" which score: 0 and the right end represented and "the most imaginable" which score: 100. Subject need to mark X somewhere along the horizontal line given before drink and before OGDS procedure. Score of each parameter will be reported as mm.
baseline (before drink) and 120minutes after drinking

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universiti Sains Malaysia

Investigators

  • Principal Investigator: Bee Chen Lua, M.D., USM surgery

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 1, 2019

Primary Completion (Anticipated)

December 1, 2019

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

April 30, 2019

First Submitted That Met QC Criteria

May 9, 2019

First Posted (Actual)

May 14, 2019

Study Record Updates

Last Update Posted (Actual)

May 17, 2019

Last Update Submitted That Met QC Criteria

May 15, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • USM/JEPeM/19010082

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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