Establishing Gastric Sonography in a Swiss Teaching Hospital

Gastric Ultrasound Clinical Trial

Official title:

Establishing Routine Preoperative Gastric Ultrasound for Patients With an Increased Aspiration Risk in a Swiss Teaching Hospital: A Prospective Observational Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04738006
• Other study ID #: V2.0 - 08.01.2021
• Status: Completed
• Start date: January 18, 2021
• Est. completion date: December 31, 2021

Study information

• Verified date: March 2022
• Source: Kantonsspital Winterthur KSW
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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:

1. 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.

2. Validation of our structured training/education by comparing sonographic estimated and directly measured gastric content.

3. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2003
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Gastric Ultrasound

Locations

Country	Name	City	State
Switzerland	Kantonsspital Winterthur	Winterthur	Zürich

Sponsors (1)

Lead Sponsor	Collaborator
Kantonsspital Winterthur KSW

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 year
Secondary	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.	1 year
Secondary	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.	1 year
Secondary	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.	1 year
Secondary	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.	1 year
Secondary	Anesthesiologic Management 1: descriptive	Subjective examiner rated aspiration risk (1-10) before and after sonography. Theoretical adaption of anesthesiologic management (more strict, more liberal).	1 year
Secondary	Anesthesiologic Management 2: Correlation	Correlation of examiner rated risk and management adaption with patient and surgery factors.	1 year