## Protocol Section
### Identification Module
**NCT ID:** NCT06426394

**Brief Title:** Effect of Positive End-expiratory Pressure on Gastic Residual Volume

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

#### Organization Study ID Info
**ID:** 2023-541
#### Organization
**Class:** OTHER_GOV
**Full Name:** Bakirkoy Dr. Sadi Konuk Research and Training Hospital
### Status Module
#### Completion Date
**Date:** 2025-01-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-23

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-17

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2024-12-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-20

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-14
**Study First Submit QC Date:** 2024-05-17
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER_GOV

**Name:** Başakşehir Çam & Sakura City Hospital

#### Lead Sponsor

**Class:** OTHER_GOV

**Name:** Duygu Akyol

#### Responsible Party

**Investigator Affiliation:** Bakirkoy Dr. Sadi Konuk Research and Training Hospital

**Investigator Full Name:** Duygu Akyol

**Investigator Title:** M.D, co-investigator

**Type:** SPONSOR_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** This study was designed as a prospective observational study.

**Detailed 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.

### Conditions Module

**Conditions:**

- Pediatrics

- Fasting Period

**Keywords:**

- Gastric ultrasonography

- gastric residual volume

- pediatric outpatient surgery

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 90

**Type:** ESTIMATED

**Patient Registry:** True

**Study Type:** OBSERVATIONAL

**Target Duration:** 1 Day

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Gastric residual volume

**Time Frame:** preoperatively, intraoperatively after laryngeal mask placement, before laryngeal mask removal at the end of surgery

#### Secondary Outcomes

**Description:** The secondary aim of this study was to evaluate the effect of positive end-expiratory pressures on airway pressures

**Measure:** Airway pressures

**Time Frame:** intraoperative process

### Eligibility Module

**Eligibility Criteria:** 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

**Healthy Volunteers:** True

**Maximum Age:** 11 Years

**Minimum Age:** 1 Year

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- CHILD

**Study Population:** A total of 90 patients were planned for this study.

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** dr.duyguaygun@gmail.com

**Name:** Duygu Akyol, M.d

**Phone:** +905447616034

**Role:** CONTACT

**Contact 2:**

**Email:** musaakdag33@gmail.com

**Name:** Musa Akdağ, M.d

**Phone:** +905317347672

**Role:** CONTACT

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### References

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

**PMID:** 36110490

**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.IJA_147_18.

**PMID:** 30443057

**Citation:** 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

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

**PMID:** 33096743

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-31
