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
About this trial
This is an interventional diagnostic trial for Gastric Emptying
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.
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
NCT ID
NCT06008509
First Posted
August 8, 2023
Last Updated
August 18, 2023
Sponsor
Pontificia Universidad Catolica de Chile
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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