Gastric ContentSKILLS-1NCT06320574
Nurses' Competence in Gastric Ultrasound
An observational study of Gastric Content and Healthy Volunteers, run by Radboud University Medical Center.
Trial summary
The goal of this observational cohort study is to investigate gastric ultrasound skills in surgical nurses. The main question it aims to answer is: how much training is required for surgical nurses to obtain competency in performing gastric ultrasound. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gastric Content, Healthy Volunteers
- How many people
- 8 participants
- Where
- No sites listed yet
- Study dates
- 14 Mar 2024to 1 Aug 2024
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Nurses employed at the gastro-intestinal and oncology department in the Radboudumc who underwent G-POCUS training The training goals are sufficient knowledge, skills, and attitude to achieve sufficient competence. The course will be divided into three components: 1) didactic teaching in an e-learning, study material, and picture library; 2) Interactive session consisting of a hands-on workshop by the expert sonographer and scanning of other trainees; 3) performing G-POCUS in healthy volunteers in a training environment with formal assessment.
Who may be able to join
- nurses with at least 1 year experience at the unit;
- nurses with a bachelor's degree in nursing;
- nurses with a particular interest in ultrasonography.
- nurses without previous experience in ultrasonography;
- no history of abnormal anatomy or surgery of the upper gastro-intestinal tract (previous oesophageal-, gastric-, or upper abdomen surgery, or hiatus hernia);
- no diabetes mellitus
Who cannot join
- subjects who do not provide written informed consent.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Nurses' Competence for Bedside Ultrasound Assessment of Gastric Content: a Cohort Study
The goal of this observational cohort study is to investigate gastric ultrasound skills in surgical nurses. The main question it aims to answer is:
- how much training is required for surgical nurses to obtain competency in performing gastric ultrasound.
Participants will follow a training involving
- theoretical background using e-learning, picture library and lecture
- practical skill development in an interactive hands-on workshop on live models directed by expert gastric ultrasonographer
- and formative assessments during training sessions scanning healthy volunteers by participants and examiners (expert gastric ultrasonographers).
Read the detailed description
Aims: To determine the amount of training bachelor nurses require to achieve competence in the bedside point-of-care ultrasound technique for qualitative assessment of gastric content.
Study design: prospective cohort educational study
Study population: The participants are six nurses at bachelor level with at least 1 year of experience with surgical patients. Volunteers are healthy persons without a pre-existing abnormal anatomy of the upper gastrointestinal tract.
Main study parameters/endpoints Primary outcome is the number of ultrasound examinations which is required to achieve competence in the performance of ultrasonography qualitative assessment of gastric content. The number of ultrasound assessments nurses need to achieve 90% success rate in 10 consecutive ultrasound assessments among healthy volunteers. Reference test is the ultrasound assessment of examiners experienced in (gastric) ultrasound.
Methods: The education program is developed according to relevant literature, panel discussion of a project group including relevant experts on gastric ultrasonography and nursing education.
Six nurses will follow the education program including didactic teachting and formal assessments. The didactic teaching include1) theoretical background using e-learning, picture library and lecture and 2) practical skill development in an interactive hands-on workshop on live models directed by expert gastric ultrasonographer. Formative assessments will be done by scanning healthy volunteers by participants and examiners (expert gastric ultrasonographers). Volunteers will be asked to adhere to a randomized prandial. Participants and examiners will be blinded for the prandial status of the volunteer.
Analysis: Cumulative sum scores will be estimated to determine the number of trainings that is required.
- Conditions
- Gastric Content, Healthy Volunteers
- Keywords
- Gastric Ultrasound, Nurses, Training, Competency, point-of-care ultrasound
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of required training
Main study endpoint was the number of scans nurses require to achieve sufficient competency in gastric ultrasound assessment. Competence was defined as 90% success rate in the 10 consecutive gastric ultrasound assessments.
Measured: 5 days of ultrasound assessment of 6 volunteers will be performed in 2 kind of prandial status (leading to 12 assessment per day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2024
- Study start14 Mar 2024 (estimated)
- Primary completion20 Apr 2024 (estimated)
- Study completion1 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Gastric ContentStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- 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
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Getty Huisman-de Waal, PhD, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06320574
- Sponsor's protocol ID
- 2023-16880
- Other IDs
- 2023
- Acronym
- SKILLS-1
- Status last verified
- Feb 2024
- First submitted
- 11 Feb 2024
- Last updated
- 20 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Bouvet L, Mazoit JX, Chassard D, Allaouchiche B, Boselli E, Benhamou D. Clinical assessment of the ultrasonographic measurement of antral area for estimating preoperative gastric content and volume. Anesthesiology. 2011 May;114(5):1086-92. doi: 10.1097/ALN.0b013e31820dee48.
PubMed 21364462Perlas A, Arzola C, Van de Putte P. Point-of-care gastric ultrasound and aspiration risk assessment: a narrative review. Can J Anaesth. 2018 Apr;65(4):437-448. doi: 10.1007/s12630-017-1031-9. Epub 2017 Dec 11.
PubMed 29230709Perlas A, Van de Putte P, Van Houwe P, Chan VW. I-AIM framework for point-of-care gastric ultrasound. Br J Anaesth. 2016 Jan;116(1):7-11. doi: 10.1093/bja/aev113. Epub 2015 May 7. No abstract available.
PubMed 25951832Lamm R, Collins M, Bloom J, Joel M, Iosif L, Park D, Reny J, Schultz S, Phillips B, Schwenk E, Costanzo C. Novice User Learning Curve for Handheld Gastric Point of Care Ultrasound Evaluations to Detect Delayed Return of Postoperative Peristalsis. Am Surg. 2023 Dec;89(12):6290-6292. doi: 10.1177/00031348231156770. Epub 2023 Feb 14. No abstract available.
PubMed 36787243Arzola C, Carvalho JC, Cubillos J, Ye XY, Perlas A. Anesthesiologists' learning curves for bedside qualitative ultrasound assessment of gastric content: a cohort study. Can J Anaesth. 2013 Aug;60(8):771-9. doi: 10.1007/s12630-013-9974-y. Epub 2013 May 24.
PubMed 23703533Brotfain E, Erblat A, Luft P, Elir A, Gruenbaum BF, Livshiz-Riven I, Koyfman A, Fridrich D, Koyfman L, Friger M, Grivnev A, Zlotnik A, Klein M. Nurse-performed ultrasound assessment of gastric residual volume and enteral nasogastric tube placement in the general intensive care unit. Intensive Crit Care Nurs. 2022 Apr;69:103183. doi: 10.1016/j.iccn.2021.103183. Epub 2021 Dec 16.
PubMed 34924254
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nurses' Competence for Bedside Ultrasound Assessment of Gastric Content: a Cohort Study
- ClinicalTrials.gov ID
- NCT06320574
- Acronym / sponsor ID
- SKILLS-1 / 2023-16880
- Conditions
- Gastric Content, Healthy Volunteers
- Keywords
- Gastric Ultrasound, Nurses, Training, Competency, point-of-care ultrasound
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- 14 Mar 2024 (estimated)
- Primary completion
- 20 Apr 2024 (estimated)
- Study completion
- 1 Aug 2024 (estimated)
- First posted
- 20 Mar 2024 (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 observational cohort study is to investigate gastric ultrasound skills in surgical nurses. The main question it aims to answer is:
- how much training is required for surgical nurses to obtain competency in performing gastric ultrasound.
Participants will follow a training involving
- theoretical background using e-learning, picture library and lecture
- practical skill development in an interactive hands-on workshop on live models directed by expert gastric ultrasonographer
- and formative assessments during training sessions scanning healthy volunteers by participants and examiners (expert gastric ultrasonographers).
Detailed description
Aims: To determine the amount of training bachelor nurses require to achieve competence in the bedside point-of-care ultrasound technique for qualitative assessment of gastric content.
Study design: prospective cohort educational study
Study population: The participants are six nurses at bachelor level with at least 1 year of experience with surgical patients. Volunteers are healthy persons without a pre-existing abnormal anatomy of the upper gastrointestinal tract.
Main study parameters/endpoints Primary outcome is the number of ultrasound examinations which is required to achieve competence in the performance of ultrasonography qualitative assessment of gastric content. The number of ultrasound assessments nurses need to achieve 90% success rate in 10 consecutive ultrasound assessments among healthy volunteers. Reference test is the ultrasound assessment of examiners experienced in (gastric) ultrasound.
Methods: The education program is developed according to relevant literature, panel discussion of a project group including relevant experts on gastric ultrasonography and nursing education.
Six nurses will follow the education program including didactic teachting and formal assessments. The didactic teaching include1) theoretical background using e-learning, picture library and lecture and 2) practical skill development in an interactive hands-on workshop on live models directed by expert gastric ultrasonographer. Formative assessments will be done by scanning healthy volunteers by participants and examiners (expert gastric ultrasonographers). Volunteers will be asked to adhere to a randomized prandial. Participants and examiners will be blinded for the prandial status of the volunteer.
Analysis: Cumulative sum scores will be estimated to determine the number of trainings that is required.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Nurses employed at the gastro-intestinal and oncology department in the Radboudumc who underwent G-POCUS training The training goals are sufficient knowledge, skills, and attitude to achieve sufficient competence. The course will be divided into three components: 1) didactic teaching in an e-learning, study material, and picture library; 2) Interactive session consisting of a hands-on workshop by the expert sonographer and scanning of other trainees; 3) performing G-POCUS in healthy volunteers in a training environment with formal assessment.
Key inclusion criteria (6 listed)
- nurses with at least 1 year experience at the unit;
- nurses with a bachelor's degree in nursing;
- nurses with a particular interest in ultrasonography.
- nurses without previous experience in ultrasonography;
- no history of abnormal anatomy or surgery of the upper gastro-intestinal tract (previous oesophageal-, gastric-, or upper abdomen surgery, or hiatus hernia);
Key exclusion criteria (1 listed)
- subjects who do not provide written informed consent.
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
Number of required training
Time frame: 5 days of ultrasound assessment of 6 volunteers will be performed in 2 kind of prandial status (leading to 12 assessment per day)
Main study endpoint was the number of scans nurses require to achieve sufficient competency in gastric ultrasound assessment. Competence was defined as 90% success rate in the 10 consecutive gastric ultrasound assessments.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2024.
- Background: PubMed 21364462Bouvet L, Mazoit JX, Chassard D, Allaouchiche B, Boselli E, Benhamou D. Clinical assessment of the ultrasonographic measurement of antral area for estimating preoperative gastric content and volume. Anesthesiology. 2011 May;114(5):1086-92. doi: 10.1097/ALN.0b013e31820dee48.
- Background: PubMed 29230709Perlas A, Arzola C, Van de Putte P. Point-of-care gastric ultrasound and aspiration risk assessment: a narrative review. Can J Anaesth. 2018 Apr;65(4):437-448. doi: 10.1007/s12630-017-1031-9. Epub 2017 Dec 11.
- Background: PubMed 25951832Perlas A, Van de Putte P, Van Houwe P, Chan VW. I-AIM framework for point-of-care gastric ultrasound. Br J Anaesth. 2016 Jan;116(1):7-11. doi: 10.1093/bja/aev113. Epub 2015 May 7. No abstract available.
- Background: PubMed 36787243Lamm R, Collins M, Bloom J, Joel M, Iosif L, Park D, Reny J, Schultz S, Phillips B, Schwenk E, Costanzo C. Novice User Learning Curve for Handheld Gastric Point of Care Ultrasound Evaluations to Detect Delayed Return of Postoperative Peristalsis. Am Surg. 2023 Dec;89(12):6290-6292. doi: 10.1177/00031348231156770. Epub 2023 Feb 14. No abstract available.
- Background: PubMed 23703533Arzola C, Carvalho JC, Cubillos J, Ye XY, Perlas A. Anesthesiologists' learning curves for bedside qualitative ultrasound assessment of gastric content: a cohort study. Can J Anaesth. 2013 Aug;60(8):771-9. doi: 10.1007/s12630-013-9974-y. Epub 2013 May 24.
- Background: PubMed 34924254Brotfain E, Erblat A, Luft P, Elir A, Gruenbaum BF, Livshiz-Riven I, Koyfman A, Fridrich D, Koyfman L, Friger M, Grivnev A, Zlotnik A, Klein M. Nurse-performed ultrasound assessment of gastric residual volume and enteral nasogastric tube placement in the general intensive care unit. Intensive Crit Care Nurs. 2022 Apr;69:103183. doi: 10.1016/j.iccn.2021.103183. Epub 2021 Dec 16.
- Individual participant dataSharing planned: Undecided
Related trials for Gastric Content
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
Not yet recruitingObservational study
Preoperative Gastric Ultrasound and Anaesthetic Management in Patients Undergoing Coronary Artery Bypass Grafting
Preoperative Fasting, Pulmonary Aspiration During Anesthetic Induction
Not yet recruitingObservational study
Preoperative Gastric Volume and High-Risk Gastric Content in Patients With Type 2 Diabetes Mellitus
Type 2 Diabetes Mellitus (DM), Gastric Ultrasound
Recruiting
Protective Benefits of a Clear Liquid Diet on Residual Gastric Content in Patients Taking Glucagon Like Peptide-1 Receptor (GLP-1 RA) Agonist Prior to Anesthesia
Pulmonary Aspiration
RecruitingPhase 1
Examination of How the Duration of Fasting and Temporary Stopping of GLP-1 Medications Affect the Amount of Food Left in the Stomach in People Using Liraglutide (Injected), Semaglutide (Taken by Mouth) or Semaglutide (Injected)
Obesity
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.
Getty Huisman-de Waal, PhD principal investigator
Radboud University Medical Center
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Content and Healthy Volunteers, run by Radboud University Medical Center.
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 6 inclusion and 1 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 20 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Harm H.J. van Noort, RN, PhD (+3124-3613438, harm.vannoort@radboudumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of required training (time frame: 5 days of ultrasound assessment of 6 volunteers will be performed in 2 kind of prandial status (leading to 12 assessment per day)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06320574, which also lists 6 linked publications.
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 20 Mar 2024.