Feasibility of 1 Hour Clear Fluid Fasting Prior to Paediatric GA

NCT03952260 | Completed

• 1 other identifier: 2019211-7120
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

The study is aim to investigate the appropriate fasting time for clear fluid in paediatric patients who plan for elective minor surgery. This is a randomize control trial, which patient will be selected randomly to fast for clear fluid for 1 hour or 2 hours. It is important to determine the gastric residual volume for paediatric age group prior to elective minor surgery in order to determine whether the difference between 1 hour fasting and 2 hour fasting for clear fluid is significant.

Conditions

Gastric Residual Volume

Keywords

Clear fluid fasting; residual gastric volume; paediatric anaesthesia

Outcome Measures

Primary Outcomes (1)

• Gastric residual volume by ultrasound after application of clear fluid fasting for 1 hour versus 2 hours prior to general anaesthesia

  We use ultrasound to evaluate gastric volume We scanning distal parts of the stomach-antrum in a semi-sitting or RLD position. A linear high-frequency (e.g. 5-12 MHz) transducer can be used in leaner or paediatric patients or to obtain detailed images of the gastric wall(4-6mm). Antral cross sectional area(CSA) can be measured by using two perpendicular diameters and the formula of the area of an ellipse: CSA=(AP×CC×π)/4 (AP=antero-posterior diameter and CC=craniocaudal diameter) GV (ml)=27.0+14.6×right-latCSA-1.28×age(Perlas and colleagues formula) Total gastric residual volume is then divide by body weight to get ml/kg, the lower the value the better the outcome. Referance standard is gastric residual volume acquired through nasogastric suction using nasogastric tube. Result of \>1.5ml/kg show that patient posed risk of aspiration, result of \>1ml/kg is significantly increase in this study

  Prior to induction of general anaesthesia

Secondary Outcomes (2)

• Anxiety level of patients by short version of(mYPAS)modified Yale Preoperative Anxiety Scale after application of clear fluid fasting for 1 hour versus 2 hours prior to paediatric general anaesthesia

  Prior to induction of general anaesthesia and 1 hour post anaesthesia

• Parental satisfaction by questionnaires after application of clear fluid fasting for 1 hour versus 2 hours prior to paediatric general anaesthesia

  2 hours to 24 hours post anaesthesia

Study Arms (2)

Fasting clear fluid for 1 hour prior to anaesthesia

ACTIVE COMPARATOR

Fasting clear fluid for 1 hour prior to anaesthesia

Other: Fasting time for clear fluid prior to anaesthesia

Fasting clear fluid for 2 hours prior to anaesthesia

NO INTERVENTION

Fasting clear fluid for 2 hours prior to anaesthesia

Interventions

Fasting time for clear fluid prior to anaesthesia OTHER

This study is to evaluate the latest fasting protocol that is currently adopted and recommended by United Kingdom, France and Royal Children Hospital Melbourne. The research question is should we change our fasting protocol for paediatric patients prior to operation The anaesthesia service is being studied. Prior to induction, the amount of abdominal contents was examined using ultrasound scan. In addition, parents will complete a questionnaire after the surgery to assess anxiety level of patients before and after the surgery.

Fasting clear fluid for 1 hour prior to anaesthesia

Eligibility Criteria

• Age: 5 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• years old
• elective open minor surgery in ent, eye, dental surgery, general surgery and orthopaedics

You may not qualify if:

• Gastro-oesophageal reflux (GORD)
• renal failure
• severe cerebral palsy
• some enteropathies
• oesophageal strictures
• achalasia
• diabetes mellitus with gastroparesis
• surgical contra-indications
• Emergency cases
• patients that were already intubated

Sponsors & Collaborators

• Ma Tai Jiun: lead

Study Sites (1)

University Malaya Medical Centre

Kuala Lumpur, 50603, Malaysia

Location

Study Officials

• Ma Tai Jiun, Dr

  University of Malaya

  PRINCIPAL INVESTIGATOR

• Ina Ismiarti binti Shariffuddin, Ass. Prof

  University of Malaya

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Blinded against those who are doing ultrasound assessment of gastric residual volume prior to anaesthesia
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: May 4, 2019
• First Posted: May 16, 2019
• Study Start: May 15, 2019
• Primary Completion: December 15, 2019
• Study Completion: February 15, 2020
• Last Updated: June 2, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)