Establishing Gastric Sonography in a Swiss Teaching Hospital

NCT04738006 | Completed

• 1 other identifier: V2.0 - 08.01.2021
• Study Type: observational
• Target: 2,003
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastric Ultrasound

Keywords

Teaching; Gastric Content; RSI; Aspiration; Gastric Volume; Sonography; Ultrasound

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Training Performance 1: Descriptive over all sonographies performed

  1 year

• Training Performance 2: over time

  1 year

• Training Performance 3: Confounders

  1 year

• Patient population and fasting/gastric volume

  1 year

• Anesthesiologic Management 1: descriptive

  1 year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kantonsspital Winterthur KSW: lead

Study Sites (1)

Kantonsspital Winterthur

Winterthur, Canton of Zurich, 8400, Switzerland

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 20, 2021
• First Posted: February 4, 2021
• Study Start: January 18, 2021
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: March 31, 2022

Record last verified: 2022-03

Locations

CH (1)