Effect of Positive End-expiratory Pressure on Gastic Residual Volume

Pediatrics Clinical Trial

Official title:

The Effect of End-expiratory Positive Pressure on Gastric Residual Volume in Elective Pediatric Outpatient Surgery Where Laryngeal Mask is Applied

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06426394
• Other study ID #: 2023-541
• Status: Not yet recruiting
• Start date: May 20, 2024
• Est. completion date: January 31, 2025

Study information

• Verified date: May 2024
• Source: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
• Contact: Duygu Akyol, M.d
• Phone: +905447616034
• Email: dr.duyguaygun[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

This study was designed as a prospective observational study.

Description:

In this study, it was planned to evaluate the effect of positive end-expiratory pressure on gastric residual volume in patients who will undergo outpatient pediatric surgery with laryngeal mask application on the specified dates. Patients aged 1-11 years, ASA I-II and undergoing outpatient lower abdominal and genitourinary surgery were included in the study. Since the use of positive end-expiratory pressure varies in our clinic depending on the anesthesiologist preference, the effect of this application on gastric volume will also be evaluated primarily by recording images with gastric ultrasonography at certain perioperative time periods. Secondarily, the effect of this positive end-expiratory pressure on mechanical ventilator parameters and airway pressures will be evaluated.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: January 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Year to 11 Years

Eligibility

Inclusion Criteria:

• Pediatric patients who will undergo elective outpatient minor surgery (lower abdominal and urogenital)

• 1-11 years old

• American Society of Anesthesiology (ASA) classification 1-2 patient groups

• Patients who are fully hungry and whose fasting period is appropriate for their age and diet.

Exclusion Criteria:

• Patients whose fasting period is not appropriate

• Acute abdominal and emergency surgeries

• ASA 3-4 patient group

• Patients with diseases or medication use that will affect gastric emptying time

• Previous nasogastric tube placement and re-operation • Patients with known difficult airway or failure to fit the laryngeal mask

Related Conditions & MeSH terms

• Fasting Period
• Pediatrics

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Duygu Akyol	Basaksehir Çam & Sakura City Hospital

References & Publications (4)

Beck CE, Rudolp D, Becke-Jakob K, Schindler E, Etspuler A, Trapp A, Fink G, Muller-Lobeck L, Roher K, Genahr A, Eich C, Sumpelmann R. Real fasting times and incidence of pulmonary aspiration in children: Results of a German prospective multicenter observa — View Citation

Fiedler MO, Schatzle E, Contzen M, Gernoth C, Weiss C, Walter T, Viergutz T, Kalenka A. Evaluation of Different Positive End-Expiratory Pressures Using Supreme Airway Laryngeal Mask during Minor Surgical Procedures in Children. Medicina (Kaunas). 2020 Oct — View Citation

Gunasekaran A, Govindaraj K, Gupta SL, Vinayagam S, Mishra SK. Comparison of Gastric Insufflation Volume Between Ambu AuraGain and ProSeal Laryngeal Mask Airway Using Ultrasonography in Patients Undergoing General Anesthesia: A Randomized Controlled Trial — View Citation

Sharma G, Jacob R, Mahankali S, Ravindra MN. Preoperative assessment of gastric contents and volume using bedside ultrasound in adult patients: A prospective, observational, correlation study. Indian J Anaesth. 2018 Oct;62(10):753-758. doi: 10.4103/ija.IJ — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gastric residual volume	The primary purpose of this study is to measure gastric residual volume with peroperative gastric ultrasonography measurements. Gastric residual volume will be calculated according to gastric ultrasonography measurements.	preoperatively, intraoperatively after laryngeal mask placement, before laryngeal mask removal at the end of surgery
Secondary	Airway pressures	The secondary aim of this study was to evaluate the effect of positive end-expiratory pressures on airway pressures	intraoperative process