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

Fasting Clinical Trial

— BreakFast  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05743803
• Other study ID #: 2023-AR23_00060
• Status: Completed
• Start date: February 27, 2023
• Est. completion date: August 20, 2023

Study information

• Verified date: September 2023
• Source: University Hospital, Angers
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 364
• Est. completion date: August 20, 2023
• Est. primary completion date: July 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Fasting

Intervention

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.

Locations

Country	Name	City	State
France	CHU Angers	Angers

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

Outcome

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