Gastric UltrasoundNCT04738006
Establishing Gastric Sonography in a Swiss Teaching Hospital
An observational study of Gastric Ultrasound, run by Kantonsspital Winterthur KSW at 1 site in Switzerland.
Trial summary
Preoperative gastric sonography may provide a validated, reliable, fast, and cost-efficient approach to assess aspiration risks in both elective and emergency patients. Practiced sonographers are able to perform point-of-care gastric sonography in a few minutes, thus severe delay in daily clinical practice should not… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Ultrasound
- How many people
- 2,003 participants
- Where
- 1 siteSwitzerland
- Study dates
- 18 Jan 2021to 31 Dec 2021
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Within a study period of 12 months (estimated), all elective and emergency patients scheduled for a Rapid Sequence Induction (RSI) and patients with one or more aspiration risk factors scheduled for a advanced laryngeal mask or regional anaesthesia will be screened for possible participation in this study. The indication for RSI and aspiration risk evaluation is previously determined by the responsible anaesthetist and based on patient medical history and clinical findings according to department standards. After evaluation of eligibility, the responsible anaesthesiologist will work through the list of inclusion and exclusion criteria. Of note, patients which are of the highest urgency where a delay is medically and ethically not acceptable, will not be included in this study. Also, patients where ability to consent is not given due to patient or circumstantial reasons, will be excluded.
Who may be able to join
- All elective in-hospital Rapid Sequence Inductions (RSI) and patients with one or more aspiration risk factors scheduled for a advanced laryngeal mask or regional anaesthesia with informed consent.
- All emergency in-hospital RSIs and patients with one or more aspiration risk factors scheduled for an advanced laryngeal mask or regional anaesthesia with informed consent graded "Notfall 1-6h, nicht vital (dringlicher Eingriff)" or, "Notfall 6-24h nicht vital (aufgeschobener dringlicher Eingriff)" according to the Swiss Society for Anaesthesiology and Resuscitation (A-QUA).
Who cannot join
- Life threatening/ time critical emergency interventions, graded followingly according to the Swiss Society for Anaesthesiology and Resuscitation (A-QUA): Notfall <1h, vital (sofortiger Eingriff notwendig)
- Known pregnancy
- Obstetric surgery
- Underage (< 18 years)
- Absence of informed consent (missing or inability to provide)
- No anaesthetist with completed structural education is available.
- Contraindications for naso- or orogastric tubes or inability to correctly place such.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Kantonsspital Winterthur
Winterthur, Canton of Zurich, 8400
About this study
Official title: Establishing Routine Preoperative Gastric Ultrasound for Patients With an Increased Aspiration Risk in a Swiss Teaching Hospital: A Prospective Observational Study.
Preoperative gastric sonography may provide a validated, reliable, fast, and cost-efficient approach to assess aspiration risks in both elective and emergency patients. Practiced sonographers are able to perform point-of-care gastric sonography in a few minutes, thus severe delay in daily clinical practice should not be expected. Nevertheless, how this highly sensitive and specific tool should be best established in daily clinical practice is still unclear. There are no preexisting structured and validated trainings for this specific point-of-care ultrasound application. To address these issues, all patients with increased aspiration risk at the Institute of Anaesthesiology in Winterthur will be evaluated for participation during a one year recruiting period. Participants will receive a preoperative gastric ultrasound by a trained professional.
The aim of this investigation is to validate our structural training and proof the importance and effectiveness of this diagnostic tool to lay ground for improvement of anesthesiologic management and presumably patient safety in patients with an increased risk of a pulmonary aspiration.
Read the detailed description
Aspiration pneumonias still exhibit a significant morbidity and mortality and are accountable for a significant part of anaesthesia-related deaths. Various diseases and especially emergency situations correlate with prolonged gastric emptying and therefore with a higher risk of pulmonary aspiration. In clinical practice the decision to perform a Rapid Sequence Induction (RSI) is mostly based on clinical and anamnestic findings. Preoperative gastric sonography may provide an objective, validated, non-invasive, reliable, fast, and cost-efficient approach to assess aspiration risks in both elective and emergency patients.
How this highly sensitive and specific tool may be best introduced and implemented in daily clinical practice or anesthesiologic guidelines remains unclear. Structured educational programmes or training recommendations for this point-of-care ultrasound application rarely exist.
Objectives:
- Establish preoperative gastric sonography before Rapid Sequence Induction (RSI) and in patients with one or more aspiration risk factors scheduled for a advanced laryngeal mask (LMa) or regional anaesthesia at the Kantonsspital Winterthur, Department of Anaesthesiology.
- Validation of our structured training/education by comparing sonographic estimated and directly measured gastric content.
- Emphasize the importance and effectiveness of this diagnostic tool to improve anesthesiologic management.
At the Cantonal Hospital of Winterthur, a mid-size Swiss teaching hospital all residents and attending anaesthesiologists will receive a structured training in a period of 1 to 8 weeks before inclusion of the first patient. All participating staff will give written informed consent to participate in the study.
Tutors/experts are all expert sonographers on different modalities. They will receive a preceding training, consisting of a theoretic introduction and a course by a radiologist and abdominal sonography expert, certified by the Swiss Society for Sonography.
All included candidates will receive a structured preoperative sonography. Primary, a qualitative assessment of the gastric content should be performed in supine and right-lateral decubitus (RLD) position. In low volume states a right-lateral decubitus position (RLD) has the advantage of a gravitational shift to the antrum. That is why the investigators plan to perform the examination in both positions. If RLD position is not possible due to patient factors a half sitting or supine position can be tried. Gastric content will be classified into empty, fluid, solid or mixed. After identification, cross sectional area (CSA) will be measured and gastric content is estimated.
After placement of the routine naso- or orogastric tube (standard for RSI and LMa patients at our institute) the investigators compare the calculated and effective suctioned volume of the gastric content and analyse the difference and quality of the sonographic measurement.
No changes in or adaptions of the established clinical practice will be made for the sole purpose of this study. In exceptional cases the responsible anaesthesiologist is allowed to upgrade patients from an advanced laryngeal mask to a RSI (gold standard) after ultrasound performance to ensure patient safety. Downgrading from RSI to advanced laryngeal maks on base of the ultrasound results is not allowed.
- Conditions
- Gastric Ultrasound
- Keywords
- Teaching, Gastric Content, RSI, Aspiration, Gastric Volume, Sonography, Ultrasound
What is being measured
The primary outcome is the main question the study is designed to answer.
Training Validation
Correlation of sonographic estimated gastric volume (CSA to ml) with volume aspirated (ml) through a naso- or oro-gastric tube, that was placed by routine due to the RSI or LMa procedure itself.
Measured: 1 year
Secondary outcomes (6)
Training Performance 1: Descriptive over all sonographies performed
Indirect success factors during program will be assessed as a direct PDMS (patient data management system) based feedback after each sonography in form of a questionnaire: time for examination (minutes), need of supervision (yes/no), correction of results by supervisor (yes/no), sonography difficulty (easy/medium/hard), inability to perform sonography (yes/no). Descriptive Statistics of the results including the whole study population.
Measured: 1 year
Training Performance 2: over time
Correlation of time for examination (min), need of supervision (yes/no), correction of results corrected by supervisor (yes/no), sonography difficulty (easy/medium/hard), inability to perform sonography (yes/no) with number of examinations over time (number of sonographies), assessed over the institute (all participants) and individual learning curves. Correlation with experience in sonography, personal interest of the sonographer, job level of the examiner.
Measured: 1 year
Training Performance 3: Confounders
Correlation of possible confounders (patient characteristics as BMI in kg/m2, American Society of Anesthesiologists (ASA) classification 1-5, patient position supine/sitting/right sided, ultrasound machine model) in Training Performance 1 and 2 analyses.
Measured: 1 year
Patient population and fasting/gastric volume
Correlation of gastric volume (ml), fasting with time since last ingestion p.o. (h), patient characteristics as BMI (kg/m2)/ASA (1-5)/type of surgery/A-QUA and individual aspiration risk factors (as renal insufficiency, non-fasted patients, trauma, diabetes, BMI). Correlation of non-fluid CSA (cm2) with above factors and number of Aspirations in the population.
Measured: 1 year
Anesthesiologic Management 1: descriptive
Subjective examiner rated aspiration risk (1-10) before and after sonography. Theoretical adaption of anesthesiologic management (more strict, more liberal).
Measured: 1 year
Anesthesiologic Management 2: Correlation
Correlation of examiner rated risk and management adaption with patient and surgery factors.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2021
- Study start18 Jan 2021
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric UltrasoundStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,003 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kantonsspital Winterthur KSW
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roman Meierhans, Kantonsspital Winterthur KSW
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04738006
- Sponsor's protocol ID
- V2.0 - 08.01.2021
- Status last verified
- Mar 2022
- First submitted
- 20 Jan 2021
- Last updated
- 31 Mar 2022
- 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 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishing Routine Preoperative Gastric Ultrasound for Patients With an Increased Aspiration Risk in a Swiss Teaching Hospital: A Prospective Observational Study.
- ClinicalTrials.gov ID
- NCT04738006
- Acronym / sponsor ID
- V2.0 - 08.01.2021
- Conditions
- Gastric Ultrasound
- Keywords
- Teaching, Gastric Content, RSI, Aspiration, Gastric Volume, Sonography, Ultrasound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,003 participants (actual)
- Lead sponsor
- Kantonsspital Winterthur KSWUniversity, hospital or other
- Study start
- 18 Jan 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 4 Feb 2021 (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.
Preoperative gastric sonography may provide a validated, reliable, fast, and cost-efficient approach to assess aspiration risks in both elective and emergency patients. Practiced sonographers are able to perform point-of-care gastric sonography in a few minutes, thus severe delay in daily clinical practice should not be expected. Nevertheless, how this highly sensitive and specific tool should be best established in daily clinical practice is still unclear. There are no preexisting structured and validated trainings for this specific point-of-care ultrasound application. To address these issues, all patients with increased aspiration risk at the Institute of Anaesthesiology in Winterthur will be evaluated for participation during a one year recruiting period. Participants will receive a preoperative gastric ultrasound by a trained professional.
The aim of this investigation is to validate our structural training and proof the importance and effectiveness of this diagnostic tool to lay ground for improvement of anesthesiologic management and presumably patient safety in patients with an increased risk of a pulmonary aspiration.
Detailed description
Aspiration pneumonias still exhibit a significant morbidity and mortality and are accountable for a significant part of anaesthesia-related deaths. Various diseases and especially emergency situations correlate with prolonged gastric emptying and therefore with a higher risk of pulmonary aspiration. In clinical practice the decision to perform a Rapid Sequence Induction (RSI) is mostly based on clinical and anamnestic findings. Preoperative gastric sonography may provide an objective, validated, non-invasive, reliable, fast, and cost-efficient approach to assess aspiration risks in both elective and emergency patients.
How this highly sensitive and specific tool may be best introduced and implemented in daily clinical practice or anesthesiologic guidelines remains unclear. Structured educational programmes or training recommendations for this point-of-care ultrasound application rarely exist.
Objectives:
- Establish preoperative gastric sonography before Rapid Sequence Induction (RSI) and in patients with one or more aspiration risk factors scheduled for a advanced laryngeal mask (LMa) or regional anaesthesia at the Kantonsspital Winterthur, Department of Anaesthesiology.
- Validation of our structured training/education by comparing sonographic estimated and directly measured gastric content.
- Emphasize the importance and effectiveness of this diagnostic tool to improve anesthesiologic management.
At the Cantonal Hospital of Winterthur, a mid-size Swiss teaching hospital all residents and attending anaesthesiologists will receive a structured training in a period of 1 to 8 weeks before inclusion of the first patient. All participating staff will give written informed consent to participate in the study.
Tutors/experts are all expert sonographers on different modalities. They will receive a preceding training, consisting of a theoretic introduction and a course by a radiologist and abdominal sonography expert, certified by the Swiss Society for Sonography.
All included candidates will receive a structured preoperative sonography. Primary, a qualitative assessment of the gastric content should be performed in supine and right-lateral decubitus (RLD) position. In low volume states a right-lateral decubitus position (RLD) has the advantage of a gravitational shift to the antrum. That is why the investigators plan to perform the examination in both positions. If RLD position is not possible due to patient factors a half sitting or supine position can be tried. Gastric content will be classified into empty, fluid, solid or mixed. After identification, cross sectional area (CSA) will be measured and gastric content is estimated.
After placement of the routine naso- or orogastric tube (standard for RSI and LMa patients at our institute) the investigators compare the calculated and effective suctioned volume of the gastric content and analyse the difference and quality of the sonographic measurement.
No changes in or adaptions of the established clinical practice will be made for the sole purpose of this study. In exceptional cases the responsible anaesthesiologist is allowed to upgrade patients from an advanced laryngeal mask to a RSI (gold standard) after ultrasound performance to ensure patient safety. Downgrading from RSI to advanced laryngeal maks on base of the ultrasound results is not allowed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Within a study period of 12 months (estimated), all elective and emergency patients scheduled for a Rapid Sequence Induction (RSI) and patients with one or more aspiration risk factors scheduled for a advanced laryngeal mask or regional anaesthesia will be screened for possible participation in this study. The indication for RSI and aspiration risk evaluation is previously determined by the responsible anaesthetist and based on patient medical history and clinical findings according to department standards. After evaluation of eligibility, the responsible anaesthesiologist will work through the list of inclusion and exclusion criteria. Of note, patients which are of the highest urgency where a delay is medically and ethically not acceptable, will not be included in this study. Also, patients where ability to consent is not given due to patient or circumstantial reasons, will be excluded.
Key inclusion criteria (2 listed)
- All elective in-hospital Rapid Sequence Inductions (RSI) and patients with one or more aspiration risk factors scheduled for a advanced laryngeal mask or regional anaesthesia with informed consent.
- All emergency in-hospital RSIs and patients with one or more aspiration risk factors scheduled for an advanced laryngeal mask or regional anaesthesia with informed consent graded "Notfall 1-6h, nicht vital (dringlicher Eingriff)" or, "Notfall 6-24h nicht vital (aufgeschobener dringlicher Eingriff)" according to the Swiss Society for Anaesthesiology and Resuscitation (A-QUA).
Key exclusion criteria (7 listed)
- Life threatening/ time critical emergency interventions, graded followingly according to the Swiss Society for Anaesthesiology and Resuscitation (A-QUA): Notfall <1h, vital (sofortiger Eingriff notwendig)
- Known pregnancy
- Obstetric surgery
- Underage (< 18 years)
- Absence of informed consent (missing or inability to provide)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Training Validation
Time frame: 1 year
Correlation of sonographic estimated gastric volume (CSA to ml) with volume aspirated (ml) through a naso- or oro-gastric tube, that was placed by routine due to the RSI or LMa procedure itself.
6 secondary outcomes
Training Performance 1: Descriptive over all sonographies performed
Time frame: 1 year
Training Performance 2: over time
Time frame: 1 year
Training Performance 3: Confounders
Time frame: 1 year
Patient population and fasting/gastric volume
Time frame: 1 year
Anesthesiologic Management 1: descriptive
Time frame: 1 year
Anesthesiologic Management 2: Correlation
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Ultrasound, run by Kantonsspital Winterthur KSW at 1 site in Switzerland.
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 2 inclusion and 7 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: finished, as of the sponsor's last update on 31 Mar 2022. 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 Switzerland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Training Validation (time frame: 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 31 Mar 2022.