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POCUS for Gastric Emptying in Emergency Surgery (EcoGastric)

Primary Purpose

Gastric Emptying, Abdomen, Acute

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Gastric echography preoperative
Sponsored by
Pontificia Universidad Catolica de Chile
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Gastric Emptying

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Adults patients Emergency surgery Diagnosis of Acute Abdomen Exclusion Criteria: Younger than 18 years old No posibility of adopt lateral decubitus.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Gastric Echography

    Arm Description

    All the patients that entry to the study are going to recieve gastric echography to determine the level of gastric emptying before the induction of anesthesia.

    Outcomes

    Primary Outcome Measures

    Number of patients with properative full stomach and type of content that they present
    Number of patients that present full stomach determinated by a mathematical formula obtained by a prior study of Perlas et al, according to the gastric perimeter measured in centimeters. In case of the stomach present content by the formula, the contet will be described in three categories: Solid, liquid or difusse.

    Secondary Outcome Measures

    Relation between some interventions, for instance: use of antibiotics, antiinflamatory drugs and time of fasting with gastric emptying.
    To relate the Number of patients with full stomach and numer of patients with diferent variables collected in the preoperative period, for example: number of fasting hours (continue variable in hours), use of antibiotics (yes or no), use of analgesic (yes or no).

    Full Information

    First Posted
    August 8, 2023
    Last Updated
    August 18, 2023
    Sponsor
    Pontificia Universidad Catolica de Chile
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06008509
    Brief Title
    POCUS for Gastric Emptying in Emergency Surgery
    Acronym
    EcoGastric
    Official Title
    Determination of Gastric Content Using Ultrasonography in Patients Undergoing Emergency Surgery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 30, 2023 (Anticipated)
    Primary Completion Date
    July 30, 2024 (Anticipated)
    Study Completion Date
    December 30, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Pontificia Universidad Catolica de Chile

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The goal of this clinical trial is to learn about the gastric emptying in adult patients that are going to operatin theatre due to an abdominal acute disease, for instance, intestinal obstruction or cholecystitis. This kind of patients are traditionally considered as a full stomach and the induction of anesthesia include rapid sequence intubation (RSI) in order to decrease the risk of aspiration . However, image technologies, like echography, allow the visualization of the stomach and to measure the amount and characteristics of the content lodged in the stomach. This information is vital to decide if RSI is necesary or not. The main question[s] it aims to answer are: What is the percentages of full stomach in patient who come to the operating room due an abodiminal acute disease? Are different variables, namely, time since diagnosis, use of antibiotics or non steroidal antiinflamatory drugs related with the content of the stomach? Participants will be evaluated with ecography to determinate the amount of content of the stomach before the surgery in the operating room.
    Detailed Description
    The pulmonary aspiration of gastric contents is a serious anesthetic complication with high associated morbidity and mortality. Its incidence is estimated to be between 0.1% and 19% of cases of general anesthesia. It is associated with admission to intensive care units, prolonged mechanical ventilation, and mortality, which can reach up to 5%. On the other hand, it accounts for 9% of anesthesia-related death). Given this, in patients at risk of aspiration, such as non-compliance with fasting or acute abdominal pathology, rapid sequence induction is routinely used. However, this technique is not without risks, being associated with episodes of desaturation, hyperkalemia, among others. Therefore, it is reasonable to question the widespread use of this technique in all urgent surgeries for acute abdominal pathologies, based solely on the pathophysiological concept that inflammation and pain could be associated with delayed gastric emptying and therefore a higher risk of aspiration, especially in high-risk populations for desaturation and difficult airway, such as pediatric patients or pregnant women. The use of ultrasound for determining gastric content is a feasible tool to assess the risk of aspiration. The best results have been obtained using curved transducers, with the patient in a semi-sitting or right lateral decubitus position, where the evaluation of the gastric antrum has shown better sensitivity in detecting content in patients with prolonged fasting. Multiple studies have been conducted in adult and pediatric patients, including obstetric and obese patients, for whom the technique could be more challenging, achieving high sensitivity and specificity in determining gastric content with ultrasound based on standardized measurements of the antrum. The purpose of this study is to describe the percentage of patients that have full stomach just befor the induction of the anesthesia and to evaluate if preoperatory treatments and time since the diagnosis are related with the gastric emptying.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Gastric Emptying, Abdomen, Acute

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    Descriptive study where patients are going to recieve and abdominal image exam (gastric Ultrasound)
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    300 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Gastric Echography
    Arm Type
    Experimental
    Arm Description
    All the patients that entry to the study are going to recieve gastric echography to determine the level of gastric emptying before the induction of anesthesia.
    Intervention Type
    Procedure
    Intervention Name(s)
    Gastric echography preoperative
    Intervention Description
    Patients with acute abdomen that are going to surgery, are going to recieve a gastric echography in the surgery room before the start of anesthesia. This procedure include vision of the stomach during supine position and lateral position with curve transductor.
    Primary Outcome Measure Information:
    Title
    Number of patients with properative full stomach and type of content that they present
    Description
    Number of patients that present full stomach determinated by a mathematical formula obtained by a prior study of Perlas et al, according to the gastric perimeter measured in centimeters. In case of the stomach present content by the formula, the contet will be described in three categories: Solid, liquid or difusse.
    Time Frame
    Through study completion, an average of 1 year
    Secondary Outcome Measure Information:
    Title
    Relation between some interventions, for instance: use of antibiotics, antiinflamatory drugs and time of fasting with gastric emptying.
    Description
    To relate the Number of patients with full stomach and numer of patients with diferent variables collected in the preoperative period, for example: number of fasting hours (continue variable in hours), use of antibiotics (yes or no), use of analgesic (yes or no).
    Time Frame
    through study completion, an average of 1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    100 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Adults patients Emergency surgery Diagnosis of Acute Abdomen Exclusion Criteria: Younger than 18 years old No posibility of adopt lateral decubitus.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Alejandro luengo, clinical professor
    Phone
    +56990951086
    Email
    ajluengo@uc.cl
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Juan Carlos De la Cuadra, Assosiate Professor
    Organizational Affiliation
    Pontificia Universidad Catolica de Chile
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

    POCUS for Gastric Emptying in Emergency Surgery

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