Effect of Positive End-expiratory Pressure on Gastic Residual Volume

NCT ID: NCT06426394

Last Updated: 2025-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-05-17

Study Completion Date

2025-01-31

Brief Summary

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This study was designed as a prospective observational study.

Detailed Description

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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

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Pediatrics Fasting Period

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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
Minimum Eligible Age

1 Year

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Başakşehir Çam & Sakura City Hospital

OTHER_GOV

Sponsor Role collaborator

Duygu Akyol

OTHER_GOV

Sponsor Role lead

Responsible Party

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Duygu Akyol

M.D, co-investigator

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Duygu Akyol

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 36110490 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30443057 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31435997 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33096743 (View on PubMed)

Other Identifiers

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2023-541

Identifier Type: -

Identifier Source: org_study_id

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