FastingBreakFastNCT05743803
Observance of Preoperative Fasting Time a Before-and-after Sensitization Campaign to Fasting Guidelines Study
An observational study of Fasting, run by University Hospital, Angers at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fasting
- What is being tested?
- Sensititization campaign on preoperative fasting rules
- How many people
- 364 participants
- Where
- 1 siteFrance
- Study dates
- 27 Feb 2023to 20 Aug 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients undergoing a surgical procedure (scheduled or urgent) at the CHU d'Angers (France) during the inclusion period.
Who may be able to join
- Adult undergoing a surgical procedure.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Observance of Preoperative Fasting Time a Before-and-after Sensitization Campaign to Preoperative Fasting Guidelines Study
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?
Read more
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.
- Conditions
- Fasting
- Being tested
- Sensititization campaign on preoperative fasting rules
- Keywords
- fasting, quality of recovery, surgery
- Medical subject headings
- Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sensititization campaign on preoperative fasting rulesOther
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Sensititization campaign on preoperative fasting rules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting time
Liquid and solid fasting time before surgery (minutes)
Measured: Before surgery
Secondary outcomes (12)
Preoperative oral carbohydrate loading
Rate of oral cardbohydrate intake in the 2 hours preoperative period (percentage)
Measured: 2 hours preoperative period
Fasting exceeding 12 hours
Rate of fasting duration superior to 12 hours (liquid or solid) (percentage)
Measured: Before surgery
Preoperative anxiety
Scale of preoperative anxiety from 0 (no anxiety) to 10 (maximum anxiety possible)
Measured: Before surgery
Preoperative discomfort
Scale of preoperative disomfort from 0 (no discomfort) to 10 (maximum discomfort possible)
Measured: Before surgery
Feeling of thirst
Qualitative scale of preoperative thirst (none, moderate, significant)
Measured: Before surgery
Feeling of hunger
Qualitative scale of preoperative hunger (none, moderate, significant)
Measured: Before surgery
Preoperative nausea or vomiting
Rate of nausea or vomit in the preoperative period (percentage)
Measured: Before surgery
Rate of postoperative nausea or vomiting
Rate of nausea or vomit during the post-operative period (percentage)
Measured: Day of surgery
Patient satisfaction toward communication and explanation about preoperative fasting.
Binary answer (yes or no)
Measured: Day of surgery
Post-operative quality of recovery
French Quality of Recovery 15 score (
Measured: Day 1 after surgery
Length of stay
Length of stay (days)
Measured: Maximum 30 days follow up
Post-operative surgical complication
Clavien-dindo classification from 0 (no complication) to 5 (death)
Measured: Maximum 30 days follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2023
- Study start27 Feb 2023
- Primary completion20 Jul 2023
- Study completion20 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FastingStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 364 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05743803
- Sponsor's protocol ID
- 2023-AR23_00060
- Acronym
- BreakFast
- Status last verified
- Sep 2023
- First submitted
- 14 Feb 2023
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observance of Preoperative Fasting Time a Before-and-after Sensitization Campaign to Preoperative Fasting Guidelines Study
- ClinicalTrials.gov ID
- NCT05743803
- Acronym / sponsor ID
- BreakFast / 2023-AR23_00060
- Conditions
- Fasting
- Keywords
- fasting, quality of recovery, surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 364 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 27 Feb 2023 (actual)
- Primary completion
- 20 Jul 2023 (actual)
- Study completion
- 20 Aug 2023 (actual)
- First posted
- 24 Feb 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 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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Before | – | –This group will undergo their preoperative fasting period as standard care. |
| After | – | Other: Sensititization campaign on preoperative fasting rulesThis group will undergo their preoperative fasting period after the sensitization campaign about preoperative fasting rules. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients undergoing a surgical procedure (scheduled or urgent) at the CHU d'Angers (France) during the inclusion period.
Key inclusion criteria (1 listed)
- Adult undergoing a surgical procedure.
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| Sensititization campaign on preoperative fasting rules* 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. | Other | After |
Primary outcome
Fasting time
Time frame: Before surgery
Liquid and solid fasting time before surgery (minutes)
12 secondary outcomes
Preoperative oral carbohydrate loading
Time frame: 2 hours preoperative period
Fasting exceeding 12 hours
Time frame: Before surgery
Preoperative anxiety
Time frame: Before surgery
Preoperative discomfort
Time frame: Before surgery
Feeling of thirst
Time frame: Before surgery
Feeling of hunger
Time frame: Before surgery
Preoperative nausea or vomiting
Time frame: Before surgery
Rate of postoperative nausea or vomiting
Time frame: Day of surgery
Patient satisfaction toward communication and explanation about preoperative fasting.
Time frame: Day of surgery
Post-operative quality of recovery
Time frame: Day 1 after surgery
Length of stay
Time frame: Maximum 30 days follow up
Post-operative surgical complication
Time frame: Maximum 30 days follow up
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 28 Sep 2023.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Fasting, run by University Hospital, Angers at 1 site in France.
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 1 inclusion and 7 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 28 Sep 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 France. 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?
Fasting time (time frame: Before surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Sep 2023.