Comparison of Residual Gastric Volume Between Children Who Drink Different Clear Oral Fluid Volume
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age13-17
SponsorBoston Children's Hospital
About this trial
According to the American Society of Anesthesiologists (ASA) fasting guideline for patients undergoing elective surgery, the 2-hour fasting period is suggested for clear oral fluid (including water, pulp-free juice and tea or coffee without milk). This guideline does not give any suggestions for proper volume of clear oral fluid intake.
This study is a prospective randomized control trials in children aged 13 through 17 years who are scheduled for an elective upper GI endoscopy procedure in the Gastroenteral Procedure Unit (GPU) at Boston Children's Hospital. The participants will be randomly assigned into one of four groups: Group 1 will consume 3 ml/kg of clear fluid by mouth at 2-hour period before surgical scheduled time, Group 2 will consume 5 ml/kg, Group 3 will consume 7 ml/kg, and Group 4 will consume 10 ml/kg. The investigators plan to recruit 72 patients in each group and 288 patients for the whole study. Research team will collect patient's demographic data, vital signs, information about their EGD procedure. Then actual volume of the stomach content and acidity will be measured from the content that is suctioned from patient's stomach during upper GI endoscopy procedure.
The investigators believe that the information from this study will help establish a comprehensive NPO guideline.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
ASA classification: I and II
13-17 years
IPD cases or the first OPD case
Scheduled for elective EGD procedure.
Disqualifiers
Emergent EGD procedures
Patients with active upper GI bleeding
Patients who received preoperative oral medication
Patients who are diagnosed as GERD, achalasia or suspected to have gastroparesis status such as uncontrolled diabetes or end stage kidney disease.
Trial design
Design model
Parallel
Treatments tested in this trial
Clear oral fluid
Other interventionclear oral fluid including water, pulp-free juice and tea or coffee without milk.
Treatment groups
288 Participants
are divided into 4 treatment groupsGroup A: 3 ml/kg of clear oral fluidActive comparator 1 intervention
Group B: 5 ml/kg of clear oral fluidActive comparator 1 intervention
Group C: 7 ml/kg of clear oral fluidActive comparator 1 intervention
Group D: 10 ml/kg of clear oral fluidActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Gastric volume
Actual gastric content volume (ml) suctioned out of each pediatric patient's stomach
Time frame
We will collect data on a day of surgery from patient's arrival until they are discharged from PACU upto 24 hoursSecondary outcomes
1
Gastric pH
Actual gastric acidity (pH) suctioned out of each pediatric patient's stomach
Time frame
We will collect data on a day of surgery from patient's arrival until they are discharged from PACU upto 24 hours2
Incidence of pulmonary aspiration
Pulmonary aspiration is defined by the presence of gastric contents in oral cavity or aspiration of gastric content into the larynx. This may cause a syndrome of progressive dyspnea, hypoxia, bronchial wheeze and patchy collapse and consolidation on chest X-ray.
Time frame
We will collect data on a day of surgery from patient's arrival until they are discharged from PACU upto 24 hoursSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov