Establishing Routine Preoperative Gastric Ultrasound for Patients With an Increased Aspiration Risk in a Swiss Teaching Hospital: A Prospective Observational Study.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Kantonsspital Winterthur KSW
- Enrollment
- 2,003
- Locations
- 1
- Primary Endpoint
- Training Validation
Study Overview
Brief 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.
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Training Performance 3: Confounders(1 year)
- Anesthesiologic Management 1: descriptive(1 year)
- Training Performance 2: over time(1 year)
- Training Performance 1: Descriptive over all sonographies performed(1 year)
- Anesthesiologic Management 2: Correlation(1 year)
- Patient population and fasting/gastric volume(1 year)
Investigators
Roman Meierhans
Principal Investigator
Kantonsspital Winterthur KSW