Recommended Clear Fluid Intake Volume at 2 Hours Prior to Esophagogastroduodenoscopy for Adult Patients

Fasting Clinical Trial

Official title:

Recommended Clear Fluid Intake Volume at 2 Hours Prior to Esophagogastroduodenoscopy for Adult Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04501393
• Other study ID #: 382/2563
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: December 1, 2024

Study information

• Verified date: March 2023
• Source: Mahidol University
• Contact: Sirirat Rattanaarpa, MD
• Phone: 024197989
• Email: rattanaarpa.s[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Research in developing patient fasting guidelines was developed years ago. On a physiological basis, patients with a longer fasting time may have less residual gastric content and lower risk of pulmonary aspiration. The recent Practice Guidelines for Preoperative Fasting and the Use of Pharmacologic Agents to Reduce the Risk of Pulmonary Aspiration of The American Society of Anesthesiologists (ASA) was published in March 2017. Current practice consists of 2-hour fasting period for clear oral fluid (including water, pulp-free juice and tea or coffee without milk), 4- hour fasting period for breast milk and 6-hour fasting period for non-human milk and solid food. However, there are only few supportive and suggestive scientific evidences. The purpose of this study is to evaluate the current clinical practice guidelines for preoperative fasting to enhance the quality of pediatric anesthesia care and promote patient safety.The investigators plan to enroll adults aged 18-60 years, who are scheduled for esophago-gastro-duodenoscopy (EGD), in order to study the effects of fasting time and the actual intragastric volume which may help us establish a comprehensive fasting guideline.

Description:

Research in developing patient NPO guidelines was developed years ago. On a physiological basis, patients with a longer fasting time may have less residual gastric content and lower risk of pulmonary aspiration. The recent Practice Guidelines for Preoperative Fasting and the Use of Pharmacologic Agents to Reduce the Risk of Pulmonary Aspiration of The American Society of Anesthesiologists (ASA) was published in March 2017. Current practice consists of 2-hour fasting period for clear oral fluid (including water, pulp-free juice and tea or coffee without milk), 4- hour fasting period for breast milk and 6-hour fasting period for non-human milk and solid food. However, there are only few supportive (category A) and suggestive (category B) scientific evidences.

Since Maltby et al showed results of patient's safety in elective surgical patients who had clear oral fluid intake 2 hours before surgery in 1986, the published clinical evidence is still insufficient to address the relationship between pulmonary aspiration and fasting time . For breast milk, infant formula and solid food, the latest Practice Guidelines for Preoperative Fasting and the Use of Pharmacologic Agents to Reduce the Risk of Pulmonary Aspiration in 2011 also follow previous suggestion of fasting time because of inadequate updated supportive clinical trials.

The purpose of this study is to evaluate the current clinical practice guidelines for preoperative fasting to enhance the quality of pediatric anesthesia care and promote patient safety. Andersson et al. reviewed 10,015 pediatric anesthesia charts retrospectively and found an incidence of 3 cases of pulmonary aspiration in 10,000 pediatric anesthesia patients who were allowed to drink clear liquid fluids until called to operative rooms . This approach promotes patient safety by minimizing a patient's dehydration status and reduced intraoperative hypotensive events. Furthermore, shortened fasting times also decreases patient irritability and improves parental satisfaction in preoperative experiences.

The investigators plan to enroll adults ages 18-60 years old, who are scheduled for esophago-gastro-duodenoscopy (EGD) at Siriraj hospital. This observational study will be conducted in 2 stages; (1) preoperative period (2) intraoperative period. Patients' demographic information will be collected along with NPO history including times, volume and type of fluid/ food intake in the preoperative period. Intragastric volume and pH from each patient's stomach at the beginning of EGD procedure will be measured in the intraoperative period.

The investigators believe that the information from this study will help us understand the effects of NPO time and the actual intragastric volume which may help establish a comprehensive NPO guideline.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 280
• Est. completion date: December 1, 2024
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Patients who are 18-60 years scheduled for EGD procedure

• Patient who willing to participate in this study

Exclusion Criteria:

• Patient who scheduled for emergent EGD procedures

• Patients with active upper GI bleeding

• Patients who received preoperative oral medication

• BMI > 30 kg/m2

• Patients with previous GI motility or acid-base pathology

Related Conditions & MeSH terms

• Fasting

Intervention

Other:
• Clear liquid intake
Clear oral fluid including water, pulp-free juice and tea or coffee without milk

Locations

Country	Name	City	State
Thailand	Faculty of Medicine, Siriraj hospital	Bangkok Noi	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Residual gastric volume	Collect actual intra-gastric content volume after drinking assigned amount of fluid at 2-hour fasting period of each patient.	at 2 hour after drinking, during endoscopic procedure
Secondary	Gastric acidity (pH)	Collect actual intra-gastric content pH after drinking assigned amount of fluid at 2-hour fasting period of each patient.	at 2 hour after drinking, during endoscopic procedure
Secondary	Hypotension	Compare hypotension incidence of each group	at 2 hour after drinking, during endoscopic procedure
Secondary	Post operative nausea and vomitting	Compare postoperative nausea and vomiting incidence of each group	pre-endoscopic procedure
Secondary	Ready to discharge time	Compare ready to discharge time of each group	When the procedure finish until ready to discharge, approximately 1-2 hours after endoscopy