Effect of Positive End-expiratory Pressure on Gastic Residual Volume

May 17, 2024 updated by: Duygu Akyol

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

This study was designed as a prospective observational study.

Study Overview

Status

Not yet recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

A total of 90 patients were planned for this study.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gastric residual volume
Time Frame: preoperatively, intraoperatively after laryngeal mask placement, before laryngeal mask removal at the end of surgery
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Airway pressures
Time Frame: intraoperative process
The secondary aim of this study was to evaluate the effect of positive end-expiratory pressures on airway pressures
intraoperative process

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duygu Akyol

Collaborators

Başakşehir Çam & Sakura City Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 20, 2024

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

January 31, 2025

Study Registration Dates

First Submitted

May 14, 2024

First Submitted That Met QC Criteria

May 17, 2024

First Posted (Actual)

May 23, 2024

Study Record Updates

Last Update Posted (Actual)

May 23, 2024

Last Update Submitted That Met QC Criteria

May 17, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2023-541

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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