NCT06008509

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 8, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 23, 2023

Completed
8 months until next milestone

Study Start

First participant enrolled

April 24, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

April 24, 2024

Status Verified

April 1, 2024

Enrollment Period

3 months

First QC Date

August 8, 2023

Last Update Submit

April 23, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    Through study completion, an average of 1 year

Secondary Outcomes (1)

  • Relation between some interventions, for instance: use of antibiotics, antiinflamatory drugs and time of fasting with gastric emptying.

    through study completion, an average of 1 year

Study Arms (1)

Gastric Echography

EXPERIMENTAL

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.

Procedure: Gastric echography preoperative

Interventions

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.

Gastric Echography

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults patients
  • Emergency surgery
  • Diagnosis of Acute Abdomen

You may not qualify if:

  • Younger than 18 years old
  • No posibility of adopt lateral decubitus.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital clinico UC christus

Santiago, Santiago Metropolitan, Chile

RECRUITING

MeSH Terms

Conditions

Abdomen, Acute

Condition Hierarchy (Ancestors)

Abdominal PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSigns and Symptoms, Digestive

Study Officials

  • Juan Carlos De la Cuadra, Assosiate Professor

    Pontificia Universidad Catolica de Chile

    STUDY CHAIR

Central Study Contacts

Alejandro luengo, clinical professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: Descriptive study where patients are going to recieve and abdominal image exam (gastric Ultrasound)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

August 8, 2023

First Posted

August 23, 2023

Study Start

April 24, 2024

Primary Completion

July 30, 2024

Study Completion

December 30, 2024

Last Updated

April 24, 2024

Record last verified: 2024-04

Locations