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

Completed

• Conditions: Fasting
• Interventions: Other: Sensititization campaign on preoperative fasting rules

• Registration Number: NCT05743803
• Lead Sponsor: University Hospital, Angers

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-02-14
• Study First Submitted QC: 2023-02-14
• Study First Posted: 2023-02-24
• Study Start: 2023-02-27
• Primary Completion: 2023-07-20
• Study Completion: 2023-08-20
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-26
• Last Update Posted: 2023-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 364

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
After	Sensititization campaign on preoperative fasting rules	This group will undergo their preoperative fasting period after the sensitization campaign about preoperative fasting rules.

Primary Outcome Measures

Name	Time	Method
Fasting time	Before surgery	Liquid and solid fasting time before surgery (minutes)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

CHU Angers; 🇫🇷 Angers, France