Effect of Positive End-expiratory Pressure on Gastic Residual Volume

NCT06426394 | Completed

• 1 other identifier: 2023-541
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

This study was designed as a prospective observational study.

Conditions

Pediatrics; Fasting Period

Keywords

Gastric ultrasonography; gastric residual volume; pediatric outpatient surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Airway pressures

  intraoperative process

Eligibility Criteria

• Age: 1 Year - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

A total of 90 patients were planned for this study.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duygu Akyol: lead
• Başakşehir Çam & Sakura City Hospital: collaborator

Study Sites (1)

Duygu Akyol

Istanbul, Turkey (Türkiye)

Location

Related Publications (4)

• 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. Cureus. 2022 Aug 11;14(8):e27888. doi: 10.7759/cureus.27888. eCollection 2022 Aug.

  PMID: 36110490 BACKGROUND

• 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.IJA_147_18.

  PMID: 30443057 BACKGROUND

• 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 observational study. Paediatr Anaesth. 2019 Oct;29(10):1040-1045. doi: 10.1111/pan.13725. Epub 2019 Sep 4.

  PMID: 31435997 BACKGROUND

• 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 21;56(10):551. doi: 10.3390/medicina56100551.

  PMID: 33096743 BACKGROUND

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: M.D, co-investigator

Study Record Dates

• First Submitted: May 14, 2024
• First Posted: May 23, 2024
• Study Start: May 17, 2024
• Primary Completion: December 31, 2024
• Study Completion: January 31, 2025
• Last Updated: September 19, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)