Gastric EmptyingEcoGastricNCT06008509
POCUS for Gastric Emptying in Emergency Surgery
A study testing Gastric echography preoperative in people with Gastric Emptying and Abdomen, Acute, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastric Emptying, Abdomen, Acute
- What is being tested?
- Gastric echography preoperative
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChile
- Study dates
- 24 Apr 2024to 30 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults patients
- Emergency surgery
- Diagnosis of Acute Abdomen
Who cannot join
- Younger than 18 years old
- No posibility of adopt lateral decubitus.
Trial locations and contacts
1 site in 1 country.
Chile1 site, 1 recruiting
- Recruiting
Hospital clinico UC christus
Santiago, Santiago Metropolitan
alejandro luengo, instructor, +56990951086, ajluengo@uc.cl
Juan cristobal Pedemonte, Asociate Professor, +56223543269, jcpedemo@uc.cl
About this study
Official title: Determination of Gastric Content Using Ultrasonography in Patients Undergoing Emergency Surgery
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.
Read the 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.
- Conditions
- Gastric Emptying, Abdomen, Acute
- Being tested
- Gastric echography preoperative
- Medical subject headings
- Abdomen, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gastric echography preoperativeProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Gastric echography preoperative |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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).
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2023
- Study start24 Apr 2024 (estimated)
- Primary completion30 Jul 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric EmptyingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Descriptive study where patients are going to recieve and abdominal image exam (gastric Ultrasound)
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pontificia Universidad Catolica de Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alejandro Luengo, Pontificia Universidad Catolica de Chile
- Investigators
- Juan Carlos De la Cuadra, Assosiate Professor, Study chair, Pontificia Universidad Catolica de Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06008509
- Sponsor's protocol ID
- 221116005
- Acronym
- EcoGastric
- Status last verified
- Apr 2024
- First submitted
- 8 Aug 2023
- Last updated
- 24 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Gastric Content Using Ultrasonography in Patients Undergoing Emergency Surgery
- ClinicalTrials.gov ID
- NCT06008509
- Acronym / sponsor ID
- EcoGastric / 221116005
- Conditions
- Gastric Emptying, Abdomen, Acute
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Pontificia Universidad Catolica de ChileUniversity, hospital or other
- Study start
- 24 Apr 2024 (estimated)
- Primary completion
- 30 Jul 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 23 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Descriptive study where patients are going to recieve and abdominal image exam (gastric Ultrasound)
| Arm | Type | Receives |
|---|---|---|
| Gastric Echography | Experimental | Procedure: Gastric echography preoperativeAll 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults patients
- Emergency surgery
- Diagnosis of Acute Abdomen
Key exclusion criteria (2 listed)
- Younger than 18 years old
- No posibility of adopt lateral decubitus.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gastric echography preoperativePatients 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. | Procedure or surgery | Gastric Echography |
Primary outcome
Number of patients with properative full stomach and type of content that they present
Time frame: Through study completion, an average of 1 year
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.
1 secondary outcome
Relation between some interventions, for instance: use of antibiotics, antiinflamatory drugs and time of fasting with gastric emptying.
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juan Carlos De la Cuadra, Assosiate Professor study chair
Pontificia Universidad Catolica de Chile
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gastric echography preoperative in people with Gastric Emptying and Abdomen, Acute, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alejandro luengo, clinical professor (+56990951086, ajluengo@uc.cl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with properative full stomach and type of content that they present (time frame: Through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2024.