Aspiration; Gastric Contents, Anesthesia Clinical Trial
Official title:
An Evaluation of a Liberal Hydration Regimen Before Elective Caesarean Section Using
| NCT number | NCT05783427 |
| Other study ID # | GUS123 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | March 13, 2023 |
| Est. completion date | June 1, 2023 |
| Verified date | August 2023 |
| Source | Coombe Women and Infants University Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 55 |
| Est. completion date | June 1, 2023 |
| Est. primary completion date | June 1, 2023 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - planned caesarean delivery under regional anaesthesia - adhered to national fasting guidance of 6 hrs for food and 2 hours for clear fluids Exclusion Criteria: - age less than 18 - inability to understand English |
| Country | Name | City | State |
|---|---|---|---|
| Ireland | Coombe Women's Hospital | Dublin |
| Lead Sponsor | Collaborator |
|---|---|
| Coombe Women and Infants University Hospital |
Ireland,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | gastric volume | whether a liberal hydration protocol can be safely provided to pregnant women undergoing elective caesarean section. | 3 months |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
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