Clinical trial NCT06426394: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pediatrics
Fasting Period
Keywords: Gastric ultrasonography
gastric residual volume
pediatric outpatient surgery
Lead sponsor: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Başakşehir Çam & Sakura City Hospital
First posted: 2024-05-23
Enrollment: 90
Sex: ALL
Minimum age (years): 1
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: A total of 90 patients were planned for this study.

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.

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

Primary outcomes:
measure: Gastric residual volume
timeFrame: preoperatively, intraoperatively after laryngeal mask placement, before laryngeal mask removal at the end of surgery
Secondary outcomes:
measure: Airway pressures
timeFrame: intraoperative process
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Duygu Akyol
Study officials:
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.
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.
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.
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.