Aspiration; Gastric Contents, AnesthesiaNCT05783427
An Evaluation of a Liberal Hydration Regimen Before Elective Caesarean Section Using Beside Gastric Ultrasound
An observational study of Aspiration; Gastric Contents, Anesthesia, run by Coombe Women and Infants University Hospital at 1 site in Ireland.
Trial summary
The aim of this study is to compare the residual gastric volumes in non-labouring parturients prior to elective Caesarean delivery when fully fasted as per European Society of Anaesthesia pre-operative fasting guidelines against the 'Sip Til Send' fasting guideline via a paired cohort study. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Aspiration; Gastric Contents, Anesthesia
- What is being tested?
- liberal hydration
- How many people
- 55 participants
- Where
- 1 siteIreland
- Study dates
- 13 Mar 2023to 1 Jun 2023
- 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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: women who are undergoing a planned elective caesarean delivery
Who may be able to join
- planned caesarean delivery under regional anaesthesia
- adhered to national fasting guidance of 6 hrs for food and 2 hours for clear fluids
Who cannot join
- age less than 18
- inability to understand English
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Evaluation of a Liberal Hydration Regimen Before Elective Caesarean Section Using
The aim of this study is to compare the residual gastric volumes in non-labouring parturients prior to elective Caesarean delivery when fully fasted as per European Society of Anaesthesia pre-operative fasting guidelines against the 'Sip Til Send' fasting guideline via a paired cohort study. The primary hypothesis is that 'Sip Til Send' would be non-inferior to standard fasting at minimising the residual gastric volume prior to surgery.
- Conditions
- Aspiration; Gastric Contents, Anesthesia
- Being tested
- liberal hydration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
liberal hydrationOther
Also called 'sip til send'
evaluate the effect of 'Sip Til Send' on overall gastric volume pregnant women undergoing elective caesarean delivery
What is being measured
The primary outcome is the main question the study is designed to answer.
gastric volume
whether a liberal hydration protocol can be safely provided to pregnant women undergoing elective caesarean section.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2023
- Study start13 Mar 2023
- Primary completion1 Jun 2023
- Study completion1 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aspiration; Gastric Contents, AnesthesiaStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Coombe Women and Infants University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ryan Howle, Coombe Women and Infants University Hospital
- Investigators
- Ryan Howle, Principal investigator, Coombe Womens Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05783427
- Sponsor's protocol ID
- GUS123
- Status last verified
- Aug 2023
- First submitted
- 13 Mar 2023
- Last updated
- 3 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Harnett C, Connors J, Kelly S, Tan T, Howle R. Evaluation of the 'Sip Til Send' regimen before elective caesarean delivery using bedside gastric ultrasound: A paired cohort pragmatic study. Eur J Anaesthesiol. 2024 Feb 1;41(2):129-135. doi: 10.1097/EJA.0000000000001926. Epub 2023 Nov 20.
PubMed 37982593
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of a Liberal Hydration Regimen Before Elective Caesarean Section Using
- ClinicalTrials.gov ID
- NCT05783427
- Acronym / sponsor ID
- GUS123
- Conditions
- Aspiration; Gastric Contents, Anesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Coombe Women and Infants University HospitalUniversity, hospital or other
- Study start
- 13 Mar 2023 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 24 Mar 2023 (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 study is to compare the residual gastric volumes in non-labouring parturients prior to elective Caesarean delivery when fully fasted as per European Society of Anaesthesia pre-operative fasting guidelines against the 'Sip Til Send' fasting guideline via a paired cohort study. The primary hypothesis is that 'Sip Til Send' would be non-inferior to standard fasting at minimising the residual gastric volume prior to surgery.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- women who are undergoing a planned elective caesarean delivery
Key inclusion criteria (2 listed)
- planned caesarean delivery under regional anaesthesia
- adhered to national fasting guidance of 6 hrs for food and 2 hours for clear fluids
Key exclusion criteria (2 listed)
- age less than 18
- inability to understand English
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 |
|---|---|---|
| liberal hydrationAlso: 'sip til send'evaluate the effect of 'Sip Til Send' on overall gastric volume pregnant women undergoing elective caesarean delivery | Other | – |
Primary outcome
gastric volume
Time frame: 3 months
whether a liberal hydration protocol can be safely provided to pregnant women undergoing elective caesarean section.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2023.
- Derived from this study: PubMed 37982593Harnett C, Connors J, Kelly S, Tan T, Howle R. Evaluation of the 'Sip Til Send' regimen before elective caesarean delivery using bedside gastric ultrasound: A paired cohort pragmatic study. Eur J Anaesthesiol. 2024 Feb 1;41(2):129-135. doi: 10.1097/EJA.0000000000001926. Epub 2023 Nov 20.
- Individual participant dataSharing planned: Undecided
Related trials for Aspiration; Gastric Contents, Anesthesia
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
Enrolling by invitationObservational study
Effect of Glucagon-like Peptide-1 Receptor Agonists (GLP-1 RA) on Gastric Emptying
Gastric Emptying, Glucagon-Like Peptide-1 Receptor Agonists
Active, not recruiting
Sonographic Assessment of Cricoid Pressure
Aspiration; Gastric Contents, Anesthesia, Intubation Complication
RecruitingObservational study
The Million Anesthesia Cases Study (MACS) - a Cohort Study of Preoperative Fasting and Perioperative Outcomes
Anesthesia, Sedation
Active, not recruitingObservational study
Gastric Ultrasound in Pediatric Trauma Patients
Trauma; Complications, Aspiration
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.
Ryan Howle principal investigator
Coombe Womens Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aspiration; Gastric Contents, Anesthesia, run by Coombe Women and Infants University Hospital at 1 site in Ireland.
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 2 inclusion and 2 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: finished, as of the sponsor's last update on 3 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
gastric volume (time frame: 3 months). 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 NCT05783427, which also lists 1 linked publication.
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 3 Aug 2023.