Observance of Preoperative Fasting Time a Before-and-after Sensitization Campaign to Fasting Guidelines Study (BreakFast)

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?

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 Overview

• Status: Completed
• Conditions: Fasting
• Intervention / Treatment: Other: Sensititization campaign on preoperative fasting rules

• Study Type: Observational
• Enrollment (Actual): 364

Contacts and Locations

Study Locations

• France
  • Angers, France, 49000
    • Chu Angers

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

All patients undergoing a surgical procedure (scheduled or urgent) at the CHU d'Angers (France) during the inclusion period.

Description

Inclusion Criteria:

- Adult undergoing a surgical procedure.

Exclusion Criteria:

• 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)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fasting time	Liquid and solid fasting time before surgery (minutes)	Before surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of postoperative nausea or vomiting	Rate of nausea or vomit during the post-operative period (percentage)	Day of surgery
Patient satisfaction toward communication and explanation about preoperative fasting.	Binary answer (yes or no)	Day of surgery
Length of stay	Length of stay (days)	Maximum 30 days follow up
Preoperative oral carbohydrate loading	Rate of oral cardbohydrate intake in the 2 hours preoperative period (percentage)	2 hours preoperative period
Fasting exceeding 12 hours	Rate of fasting duration superior to 12 hours (liquid or solid) (percentage)	Before surgery
Preoperative anxiety	Scale of preoperative anxiety from 0 (no anxiety) to 10 (maximum anxiety possible)	Before surgery
Preoperative discomfort	Scale of preoperative disomfort from 0 (no discomfort) to 10 (maximum discomfort possible)	Before surgery
Feeling of thirst	Qualitative scale of preoperative thirst (none, moderate, significant)	Before surgery
Feeling of hunger	Qualitative scale of preoperative hunger (none, moderate, significant)	Before surgery
Preoperative nausea or vomiting	Rate of nausea or vomit in the preoperative period (percentage)	Before surgery
Post-operative quality of recovery	French Quality of Recovery 15 score (	Day 1 after surgery
Post-operative surgical complication	Clavien-dindo classification from 0 (no complication) to 5 (death)	Maximum 30 days follow up

Collaborators and Investigators

• Sponsor: University Hospital, Angers

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2023
• Primary Completion (Actual): July 20, 2023
• Study Completion (Actual): August 20, 2023

Study Registration Dates

• First Submitted: February 14, 2023
• First Submitted That Met QC Criteria: February 14, 2023
• First Posted (Actual): February 24, 2023

Study Record Updates

• Last Update Posted (Actual): September 28, 2023
• Last Update Submitted That Met QC Criteria: September 26, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: surgery; quality of recovery; fasting
• Other Study ID Numbers: 2023-AR23_00060

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No