Observance of Preoperative Fasting Time a Before-and-after Sensitization Campaign to Fasting Guidelines Study
BreakFast
1 other identifier
observational
364
1 country
1
Brief Summary
The goal of this before and after observational study is to evaluate the impact of a global sensitization campaign (targeted on surgeons, anesthetist and patients) about pre-operative fasting in an adult population. The main questions it aims to answer are:
- Does the sensitization campaign reduce fasting time?
- Does reduce fasting time increase quality of post-operative recovery? Sensitization campaign will be performed between the before and after phases, it will include:
- Planned and repeated mandatory on site lecture about pre-operative guidelines for surgeons, anesthetists and paramedics.
- Reminder display in surgical wards and consults.
- Individualized fasting cards for patients.
- Short message service reminder on pre-operative fasting rules for patients.
- Medical fasting prescription with clear fasting times.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2023
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 14, 2023
CompletedFirst Posted
Study publicly available on registry
February 24, 2023
CompletedStudy Start
First participant enrolled
February 27, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 20, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 20, 2023
CompletedSeptember 28, 2023
September 1, 2023
5 months
February 14, 2023
September 26, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Fasting time
Liquid and solid fasting time before surgery (minutes)
Before surgery
Secondary Outcomes (12)
Preoperative oral carbohydrate loading
2 hours preoperative period
Fasting exceeding 12 hours
Before surgery
Preoperative anxiety
Before surgery
Preoperative discomfort
Before surgery
Feeling of thirst
Before surgery
- +7 more secondary outcomes
Study Arms (2)
Before
This group will undergo their preoperative fasting period as standard care.
After
This group will undergo their preoperative fasting period after the sensitization campaign about preoperative fasting rules.
Interventions
* Planned and repeated mandatory on site lecture about pre-operative guidelines for surgeons, anesthetists and paramedics. * Reminder display in surgical wards and consults. * Individualized fasting cards for patients. * Short message service reminder on pre-operative fasting rules for patients. * Medical fasting prescription with clear fasting times.
Eligibility Criteria
All patients undergoing a surgical procedure (scheduled or urgent) at the CHU d'Angers (France) during the inclusion period.
You may qualify if:
- \- Adult undergoing a surgical procedure.
You may not qualify if:
- Already intubated patient before surgery.
- Redo surgery during the same hospitalization
- Medical indication of fasting (e.g : occlusive syndrome)
- Patient unable to anwser the questionnaire.
- Patient under lawful protection
- Pregnant women
- Minor (\<18 years)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU Angers
Angers, 49000, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 14, 2023
First Posted
February 24, 2023
Study Start
February 27, 2023
Primary Completion
July 20, 2023
Study Completion
August 20, 2023
Last Updated
September 28, 2023
Record last verified: 2023-09
Data Sharing
- IPD Sharing
- Will not share