Residual Gastric ContentsNCT06839248
Effect of Fasting Recommendations Among Patients Using GLP-1 Receptor Agonists
A study testing 24-hour clear liquid diet and Standard fasting guidelines in people with Residual Gastric Contents and Pulmonary Aspiration of Gastric Contents, run by St Vincent's Hospital Melbourne at 2 sites in Australia.
Trial summary
The aim of this randomised controlled trial is to determine the effect of a 24-hour clear liquid diet compared to standard fasting guidelines on the proportion of participants who present with increased residual gastric contents during their study visit. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Residual Gastric Contents, Pulmonary Aspiration of Gastric Contents
- What is being tested?
- 24-hour clear liquid diet and Standard fasting guidelines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 2 sitesAustralia
- Study dates
- 20 Jun 2025to 1 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Age ≥18 years old at enrolment.
- Have regularly administered any type of once-weekly GLP-1 RA medication for a period of at least one month prior to randomisation.
- If allocated to follow standard fasting guidelines, willing to adhere to ASA and ANZCA preoperative fasting requirements. This requires participants to only consume clear liquids up to 2 hours, a light or low calorific meal up to 6 hours, and fasting from fried foods, fatty foods, or meat for at least 8 hours prior to the trial visit.
- If allocated to follow a 24-hour clear liquid diet, willing to adhere to nothing-by-mouth (NPO) for solids and last intake of clear liquids no less than 2 hours prior to the trial visit.
- Provide a signed and dated informed consent form for study participation in line with the requirements of the human research ethics committee (HREC) of the study site.
Who cannot join
- Participants meeting any of the following criteria, indicative of abnormal anatomy and not validated by gastric ultrasound, will be excluded from this trial:
- Has a recent history of gastrointestinal bleed within the previous 1 month from enrolment.
- Has a history of previous lower oesophageal or gastric surgery.
- Has a known abnormal upper gastrointestinal anatomy, including hiatus hernia or gastric tumours.
- In addition, participants meeting any the of following criteria will be excluded from this trial:
- Participant reports having been previously diagnosed with a clinically significant gastric emptying abnormality such as gastroparesis.
Show all 9Show fewer
- Participant reports concomitant use of insulin.
- Unable to assume the right lateral decubitus position required for gastric ultrasound assessment.
- Participant has difficulty fully understanding PICF or study materials due to a primary language other than English.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Prof Michelle Dowsey, BHealthSci(Nursing), MEpi, PhD contact
Jasmin Elkin contact
Australia2 sites, 2 recruiting
- Recruiting
Melbourne Gastro Oesophageal Surgery (MGOS)
Melbourne, Victoria, 3002
Michael Hii, mhii@mgos.com.au
Jasmin Elkin, jelkin@student.unimelb.edu.au
- Recruiting
St Vincent's Hospital Melbourne
Melbourne, Victoria, 3065
Michelle Dowsey, 03 9231 3955 ext. +61, mmdowsey@unimelb.edu.au
Jasmin Elkin, jelkin@student.unimelb.edu.au
About this study
Official title: Effect of Fasting Recommendations on Residual Gastric Contents Among Patients Using Glucagon-like Peptide-1 Receptor Agonists: A Randomised Controlled Trial
The aim of this randomised controlled trial is to determine the effect of a 24-hour clear liquid diet compared to standard fasting guidelines on the proportion of participants who present with increased residual gastric contents during their study visit. It also aims to determine the effect of a 24-hour clear liquid diet compared to standard fasting guidelines on:
- Solid content or thick fluids
- Patient-reported outcome measures (PROMs), including thirst, hunger, nausea, fatigue, and anxiety.
- Compliance measures, including adherence with the intervention, time since last oral intake of solid foods, and time since last oral intake of clear liquids.
We will enrol adults who are currently using any once-weekly glucagon-like peptide-1 receptor agonist (GLP-1RA) medication. Participants will be allocated in a 1:1 ratio to follow a 24-hour clear liquid diet or standard fasting guidelines prior to attending a study visit where participants will undergo a blinded gastric ultrasound assessment.
Read the detailed description
GLP-1 RAs have had a transformative impact on the management of obesity, cardiovascular disease, and type 2 diabetes. Despite this, this class of medications pose a significant challenge in the perioperative setting, as GLP-1 RAs are known to increase patients' risk of presenting to surgery with residual gastric contents even when standard fasting guidance is adhered to. Such residual contents pose a risk for devastating complications if they are aspirated during surgery. In procedures such as upper endoscopy, where clear visualisation of the gastric tract is essential, the presence of residual contents in the stomach may result in procedures being aborted, leading to patients being exposed to additional risks associated with having to repeat the procedure. Despite the urgent need for clear guidance based on reliable evidence, healthcare professionals are currently practicing in an almost complete absence of evidence regarding the management of GLP-1 RAs in the perioperative period.
Our trial aims to address the uncertainty around pre-procedure management of patients using GLP-1 RAs by evaluating whether a 24-hour clear liquid diet can reduce the likelihood of increased residual gastric contents in patients using once-weekly GLP-1 RA medications, compared to the standard fasting guidelines currently recommended before elective procedures. Standard fasting guidelines, as defined by the ASA and ANZCA, recommend clear liquids up to 2 hours before anaesthesia, a light or low calorific meal up to 6 hours before anaesthesia, and fasting from fried foods, fatty foods, or meat for at least 8 hours prior to anaesthesia.The trial will also examine the effect of this more stringent fasting guidance on outcomes including thirst, hunger, nausea, fatigue, and anxiety, which impact both comfort and satisfaction among patients undergoing surgery.
- Being tested
- 24-hour clear liquid diet, Standard fasting guidelines
- Medical subject headings
- Respiratory Aspiration of Gastric Contents
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
24-hour clear liquid dietOther
Participants randomly assigned to this arm will be instructed to follow a 24-hour clear liquid diet, defined as NPO for solids and last intake of clear liquids no less than 2 hours prior to the trial visit.
Standard fasting guidelinesOther
Participants randomly assigned to this arm will be instructed to follow the ASA and ANZCA standards for preoperative fasting prior to presenting for their trial visit. This requires participants to only consume clear liquids up to 2 hours, a light or low calorific meal up to 6 hours, and fasting from fried foods, fatty foods, or meat for at least 8 hours prior to the trial visit.
| Study group | Role | What they receive |
|---|---|---|
| 24-hour clear liquid diet | Experimental | Not described Receives: Other: 24-hour clear liquid diet |
| Standard fasting guidelines | Active comparator | Not described Receives: Other: Standard fasting guidelines |
What is being measured
The primary outcome is the main question the study is designed to answer.
Residual gastric contents
Difference in proportion of participants who present with increased residual gastric contents, defined as >1.5mL/kg of clear fluids, thick fluids or solids, as assessed by gastric ultrasound using the clinical algorithm by Perlas and colleagues.
Measured: Immediately following fasting intervention
Secondary outcomes (9)
Solid content or thick fluids
Difference in proportion of participants who present with solid content or thick fluids, assessed by gastric ultrasound using the clinical algorithm by Perlas and colleagues.
Measured: Immediately following fasting intervention
Thirst
Mean difference in thirst, assessed using the thirst distress and thirst intensity Visual Analogue Scales.
Participants rate their level of thirst distress along a scale of 0-10cm, where 10cm represents "extreme distress" and the end closest to 0cm the represents "not distressed". Participants rate their level of thirst intensity along a scale of 0-10cm, where 10cm represents "intense thirst" and the end closest to 0cm the represents "not thirsty". The average of the thirst intensity and the thirst distress score is calculated.
Measured: Immediately following fasting intervention
Hunger
Mean difference in hunger, assessed using the Hunger and Satiety Visual Analogue Scale.
Participants rate their level of hunger along a scale of 0-10cm, where 10cm represents "I have never been more hungry, and the end closest to 0cm the represents "I am not hungry at all".
Measured: Immediately following fasting intervention
Nausea
Mean difference in nausea, assessed using a Visual Analogue Scale.
Participants rate their level of nausea along a scale of 0-10cm, where 10cm represents "worst imaginable nausea", and the end closest to 0cm the represents "no nausea".
Measured: Immediately following fasting intervention
Fatigue
Mean difference in fatigue, assessed using a Visual Analogue Scale.
Participants rate their level of fatigue along a scale of 0-10cm, where 10cm represents "extreme fatigue", and the end closest to 0cm the represents "not fatigued at all".
Measured: Immediately following fasting intervention
Anxiety
Mean difference in anxiety, assessed using the Visual Analogue Scale for Anxiety (VAS-A). Participants rate their level of anxiety along a scale of 0-10cm, where 10cm represents "most anxious I can imagine, and the end closest to 0cm the represents "not at all anxious".
Measured: Immediately following fasting intervention
Adherence to intervention
Difference in proportion of participants who adhere to allocated intervention, assessed using a dedicated case report form.
Measured: Immediately following fasting intervention
Time since last oral intake of solid foods
Mean difference in time since last oral intake of solid foods, assessed using a dedicated case report form.
Measured: Immediately following fasting intervention
Time since last oral intake of clear liquids
Mean difference in time since last oral intake of clear liquids, assessed using a dedicated case report form.
Measured: Immediately following fasting intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2025
- Study start20 Jun 2025
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Residual Gastric ContentsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 154 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St Vincent's Hospital Melbourne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Michelle Dowsey, St Vincent's Hospital Melbourne
- Investigators
- Prof Michelle Dowsey, BHealthSci(Nursing), MEpi, PhD, Principal investigator, St Vincent's Hospital Melbourne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06839248
- Sponsor's protocol ID
- 2024/PID00396
- Status last verified
- May 2026
- First submitted
- 11 Feb 2025
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The following will be made available long-term for use, by request, from future researchers from a recognised research institution whose proposed use of the data has been ethically reviewed, approved by an independent committee, and can demonstrate a safe data management plan.
Publications
Practice Guidelines for Preoperative Fasting and the Use of Pharmacologic Agents to Reduce the Risk of Pulmonary Aspiration: Application to Healthy Patients Undergoing Elective Procedures: An Updated Report by the American Society of Anesthesiologists Task Force on Preoperative Fasting and the Use of Pharmacologic Agents to Reduce the Risk of Pulmonary Aspiration. Anesthesiology. 2017 Mar;126(3):376-393. doi: 10.1097/ALN.0000000000001452. No abstract available.
PubMed 28045707Joshi GP, Abdelmalak BB, Weigel WA, Harbell MW, Kuo CI, Soriano SG, Stricker PA, Tipton T, Grant MD, Marbella AM, Agarkar M, Blanck JF, Domino KB. 2023 American Society of Anesthesiologists Practice Guidelines for Preoperative Fasting: Carbohydrate-containing Clear Liquids with or without Protein, Chewing Gum, and Pediatric Fasting Duration-A Modular Update of the 2017 American Society of Anesthesiologists Practice Guidelines for Preoperative Fasting. Anesthesiology. 2023 Feb 1;138(2):132-151. doi: 10.1097/ALN.0000000000004381.
PubMed 36629465Perlas 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 25951832Carey S, Waller J, Wang LY, Ferrie S. Qualifying thirst distress in the acute hospital setting-validation of a patient-reported outcome measure. Journal of Perioperative Nursing.2021;34(4):e38-e44.
Flint A, Raben A, Blundell JE, Astrup A. Reproducibility, power and validity of visual analogue scales in assessment of appetite sensations in single test meal studies. Int J Obes Relat Metab Disord. 2000 Jan;24(1):38-48. doi: 10.1038/sj.ijo.0801083.
PubMed 10702749Boogaerts JG, Vanacker E, Seidel L, Albert A, Bardiau FM. Assessment of postoperative nausea using a visual analogue scale. Acta Anaesthesiol Scand. 2000 Apr;44(4):470-4. doi: 10.1034/j.1399-6576.2000.440420.x.
PubMed 10757584Glaus A. Assessment of fatigue in cancer and non-cancer patients and in healthy individuals. Support Care Cancer. 1993 Nov;1(6):305-15. doi: 10.1007/BF00364968.
PubMed 8156248Desrame J, Baize N, Anota A, Laribi K, Stefani L, Hjiej S, Nabirotchkina E, Zelek L, Choquet S. Fatigue visual analogue scale score correlates with quality of life in cancer patients receiving epoetin alfa (Sandoz) for chemotherapy-induced anaemia: The CIROCO study. Cancer Treat Res Commun. 2023;37:100781. doi: 10.1016/j.ctarc.2023.100781. Epub 2023 Nov 23.
PubMed 38039763Hornblow AR, Kidson MA. The visual analogue scale for anxiety: a validation study. Aust N Z J Psychiatry. 1976 Dec;10(4):339-41. doi: 10.3109/00048677609159523. No abstract available.
PubMed 1071419Facco E, Stellini E, Bacci C, Manani G, Pavan C, Cavallin F, Zanette G. Validation of visual analogue scale for anxiety (VAS-A) in preanesthesia evaluation. Minerva Anestesiol. 2013 Dec;79(12):1389-95. Epub 2013 Jul 9.
PubMed 23860442
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Fasting Recommendations on Residual Gastric Contents Among Patients Using Glucagon-like Peptide-1 Receptor Agonists: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06839248
- Acronym / sponsor ID
- 2024/PID00396
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 154 participants (estimated)
- Lead sponsor
- St Vincent's Hospital MelbourneUniversity, hospital or other
- Study start
- 20 Jun 2025 (actual)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 21 Feb 2025 (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 aim of this randomised controlled trial is to determine the effect of a 24-hour clear liquid diet compared to standard fasting guidelines on the proportion of participants who present with increased residual gastric contents during their study visit. It also aims to determine the effect of a 24-hour clear liquid diet compared to standard fasting guidelines on:
- Solid content or thick fluids
- Patient-reported outcome measures (PROMs), including thirst, hunger, nausea, fatigue, and anxiety.
- Compliance measures, including adherence with the intervention, time since last oral intake of solid foods, and time since last oral intake of clear liquids.
We will enrol adults who are currently using any once-weekly glucagon-like peptide-1 receptor agonist (GLP-1RA) medication. Participants will be allocated in a 1:1 ratio to follow a 24-hour clear liquid diet or standard fasting guidelines prior to attending a study visit where participants will undergo a blinded gastric ultrasound assessment.
Detailed description
GLP-1 RAs have had a transformative impact on the management of obesity, cardiovascular disease, and type 2 diabetes. Despite this, this class of medications pose a significant challenge in the perioperative setting, as GLP-1 RAs are known to increase patients' risk of presenting to surgery with residual gastric contents even when standard fasting guidance is adhered to. Such residual contents pose a risk for devastating complications if they are aspirated during surgery. In procedures such as upper endoscopy, where clear visualisation of the gastric tract is essential, the presence of residual contents in the stomach may result in procedures being aborted, leading to patients being exposed to additional risks associated with having to repeat the procedure. Despite the urgent need for clear guidance based on reliable evidence, healthcare professionals are currently practicing in an almost complete absence of evidence regarding the management of GLP-1 RAs in the perioperative period.
Our trial aims to address the uncertainty around pre-procedure management of patients using GLP-1 RAs by evaluating whether a 24-hour clear liquid diet can reduce the likelihood of increased residual gastric contents in patients using once-weekly GLP-1 RA medications, compared to the standard fasting guidelines currently recommended before elective procedures. Standard fasting guidelines, as defined by the ASA and ANZCA, recommend clear liquids up to 2 hours before anaesthesia, a light or low calorific meal up to 6 hours before anaesthesia, and fasting from fried foods, fatty foods, or meat for at least 8 hours prior to anaesthesia.The trial will also examine the effect of this more stringent fasting guidance on outcomes including thirst, hunger, nausea, fatigue, and anxiety, which impact both comfort and satisfaction among patients undergoing surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 24-hour clear liquid diet | Experimental | Other: 24-hour clear liquid diet |
| Standard fasting guidelines | Active comparator | Other: Standard fasting guidelines |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥18 years old at enrolment.
- Have regularly administered any type of once-weekly GLP-1 RA medication for a period of at least one month prior to randomisation.
- If allocated to follow standard fasting guidelines, willing to adhere to ASA and ANZCA preoperative fasting requirements. This requires participants to only consume clear liquids up to 2 hours, a light or low calorific meal up to 6 hours, and fasting from fried foods, fatty foods, or meat for at least 8 hours prior to the trial visit.
- If allocated to follow a 24-hour clear liquid diet, willing to adhere to nothing-by-mouth (NPO) for solids and last intake of clear liquids no less than 2 hours prior to the trial visit.
- Provide a signed and dated informed consent form for study participation in line with the requirements of the human research ethics committee (HREC) of the study site.
Key exclusion criteria (9 listed)
- Participants meeting any of the following criteria, indicative of abnormal anatomy and not validated by gastric ultrasound, will be excluded from this trial:
- Has a recent history of gastrointestinal bleed within the previous 1 month from enrolment.
- Has a history of previous lower oesophageal or gastric surgery.
- Has a known abnormal upper gastrointestinal anatomy, including hiatus hernia or gastric tumours.
- In addition, participants meeting any the of following criteria will be excluded from this trial:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 24-hour clear liquid dietParticipants randomly assigned to this arm will be instructed to follow a 24-hour clear liquid diet, defined as NPO for solids and last intake of clear liquids no less than 2 hours prior to the trial visit. | Other | 24-hour clear liquid diet |
| Standard fasting guidelinesParticipants randomly assigned to this arm will be instructed to follow the ASA and ANZCA standards for preoperative fasting prior to presenting for their trial visit. This requires participants to only consume clear liquids up to 2 hours, a light or low calorific meal up to 6 hours, and fasting from fried foods, fatty foods, or meat for at least 8 hours prior to the trial visit. | Other | Standard fasting guidelines |
Primary outcome
Residual gastric contents
Time frame: Immediately following fasting intervention
Difference in proportion of participants who present with increased residual gastric contents, defined as >1.5mL/kg of clear fluids, thick fluids or solids, as assessed by gastric ultrasound using the clinical algorithm by Perlas and colleagues.
9 secondary outcomes
Solid content or thick fluids
Time frame: Immediately following fasting intervention
Thirst
Time frame: Immediately following fasting intervention
Hunger
Time frame: Immediately following fasting intervention
Nausea
Time frame: Immediately following fasting intervention
Fatigue
Time frame: Immediately following fasting intervention
Anxiety
Time frame: Immediately following fasting intervention
Adherence to intervention
Time frame: Immediately following fasting intervention
Time since last oral intake of solid foods
Time frame: Immediately following fasting intervention
Time since last oral intake of clear liquids
Time frame: Immediately following fasting intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
- Background: PubMed 28045707Practice Guidelines for Preoperative Fasting and the Use of Pharmacologic Agents to Reduce the Risk of Pulmonary Aspiration: Application to Healthy Patients Undergoing Elective Procedures: An Updated Report by the American Society of Anesthesiologists Task Force on Preoperative Fasting and the Use of Pharmacologic Agents to Reduce the Risk of Pulmonary Aspiration. Anesthesiology. 2017 Mar;126(3):376-393. doi: 10.1097/ALN.0000000000001452. No abstract available.
- Background: PubMed 36629465Joshi GP, Abdelmalak BB, Weigel WA, Harbell MW, Kuo CI, Soriano SG, Stricker PA, Tipton T, Grant MD, Marbella AM, Agarkar M, Blanck JF, Domino KB. 2023 American Society of Anesthesiologists Practice Guidelines for Preoperative Fasting: Carbohydrate-containing Clear Liquids with or without Protein, Chewing Gum, and Pediatric Fasting Duration-A Modular Update of the 2017 American Society of Anesthesiologists Practice Guidelines for Preoperative Fasting. Anesthesiology. 2023 Feb 1;138(2):132-151. doi: 10.1097/ALN.0000000000004381.
- 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.
- BackgroundCarey S, Waller J, Wang LY, Ferrie S. Qualifying thirst distress in the acute hospital setting-validation of a patient-reported outcome measure. Journal of Perioperative Nursing.2021;34(4):e38-e44.
- Background: PubMed 10702749Flint A, Raben A, Blundell JE, Astrup A. Reproducibility, power and validity of visual analogue scales in assessment of appetite sensations in single test meal studies. Int J Obes Relat Metab Disord. 2000 Jan;24(1):38-48. doi: 10.1038/sj.ijo.0801083.
- Background: PubMed 10757584Boogaerts JG, Vanacker E, Seidel L, Albert A, Bardiau FM. Assessment of postoperative nausea using a visual analogue scale. Acta Anaesthesiol Scand. 2000 Apr;44(4):470-4. doi: 10.1034/j.1399-6576.2000.440420.x.
- Background: PubMed 8156248Glaus A. Assessment of fatigue in cancer and non-cancer patients and in healthy individuals. Support Care Cancer. 1993 Nov;1(6):305-15. doi: 10.1007/BF00364968.
- Background: PubMed 38039763Desrame J, Baize N, Anota A, Laribi K, Stefani L, Hjiej S, Nabirotchkina E, Zelek L, Choquet S. Fatigue visual analogue scale score correlates with quality of life in cancer patients receiving epoetin alfa (Sandoz) for chemotherapy-induced anaemia: The CIROCO study. Cancer Treat Res Commun. 2023;37:100781. doi: 10.1016/j.ctarc.2023.100781. Epub 2023 Nov 23.
- Background: PubMed 1071419Hornblow AR, Kidson MA. The visual analogue scale for anxiety: a validation study. Aust N Z J Psychiatry. 1976 Dec;10(4):339-41. doi: 10.3109/00048677609159523. No abstract available.
- Background: PubMed 23860442Facco E, Stellini E, Bacci C, Manani G, Pavan C, Cavallin F, Zanette G. Validation of visual analogue scale for anxiety (VAS-A) in preanesthesia evaluation. Minerva Anestesiol. 2013 Dec;79(12):1389-95. Epub 2013 Jul 9.
- ANZCA PG07 Guideline on pre-anaesthesia consultation and patient preparation 2024.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. The following will be made available long-term for use, by request, from future researchers from a recognised research institution whose proposed use of the data has been ethically reviewed, approved by an independent committee, and can demonstrate a safe data management plan.
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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.
Prof Michelle Dowsey, BHealthSci(Nursing), MEpi, PhD contact
Jasmin Elkin contact
Prof Michelle Dowsey, BHealthSci(Nursing), MEpi, PhD principal investigator
St Vincent's Hospital Melbourne
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 24-hour clear liquid diet and Standard fasting guidelines in people with Residual Gastric Contents and Pulmonary Aspiration of Gastric Contents, run by St Vincent's Hospital Melbourne at 2 sites in Australia.
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 5 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Prof Michelle Dowsey, BHealthSci(Nursing), MEpi, PhD (03 9231 3955 ext. 61, mmdowsey@unimelb.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Residual gastric contents (time frame: Immediately following fasting intervention). 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 NCT06839248, which also lists 10 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 11 May 2026.