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

NCT ID: NCT04501393

Last Updated: 2023-03-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 280 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-01
• Study Completion Date: 2024-12-01

Brief 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.

Detailed 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.

Conditions

Fasting

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

0 ml/kg

The participants will not be asked to drink anything at 2 hours prior to planned procedure.

Group Type: NO_INTERVENTION

No interventions assigned to this group

3 ml/kg

The participants will be asked to drink 3ml/kg of clear liquid at 2 hours prior to planned procedure.

Group Type: ACTIVE_COMPARATOR

Clear liquid intake

Intervention Type: OTHER

Clear oral fluid including water, pulp-free juice and tea or coffee without milk

7 ml/kg

The participants will be asked to drink 7 ml/kg of clear liquid at 2 hours prior to planned procedure.

Group Type: ACTIVE_COMPARATOR

Clear liquid intake

Intervention Type: OTHER

Clear oral fluid including water, pulp-free juice and tea or coffee without milk

10 ml/kg

The participants will be asked to drink 10 ml/kg of clear liquid at 2 hours prior to planned procedure.

Group Type: ACTIVE_COMPARATOR

Clear liquid intake

Intervention Type: OTHER

Clear oral fluid including water, pulp-free juice and tea or coffee without milk

Interventions

Clear liquid intake

Clear oral fluid including water, pulp-free juice and tea or coffee without milk

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mahidol University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Faculty of Medicine, Siriraj hospital

Bangkok Noi, Bangkok, Thailand

Site Status: RECRUITING

Countries

Thailand

Central Contacts

Sirirat Rattanaarpa, MD

Role: CONTACT

rattanaarpa.s@gmail.com

024197989

Patcharee Sriswasdi, MD, MPH

Role: CONTACT

pat.si.research@gmail.com

024197989

Facility Contacts

Sirirat Rattana-arpa, MD

Role: primary

mednoonr@gmail.com

+66819099242

Other Identifiers

382/2563

Identifier Type: -

Identifier Source: org_study_id