BreakFast: Observance of Preoperative Fasting Time. Effect of a Global Sensitization Campaign to Preoperative Fasting Guidelines, a Before-and-after Study.

Sponsor

University Hospital, Angers (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05743803

Collaborator

(none)

300

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Perioperative Fasting	Other: Sensititization campaign on preoperative fasting rules

Study Design

Study Type:

Observational

Anticipated Enrollment :

300 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

Observance of Preoperative Fasting Time. Effect of a Global Sensitization Campaign to Preoperative Fasting Guidelines, a Before-and-after Study. The BreakFast Study.

Anticipated Study Start Date :

Feb 27, 2023

Anticipated Primary Completion Date :

Jun 28, 2023

Anticipated Study Completion Date :

Jun 28, 2023

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

Fasting time [Day of surgery]
Liquid and solid fasting time before surgery (minutes)

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University Hospital, Angers

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Angers

ClinicalTrials.gov Identifier:

NCT05743803

Other Study ID Numbers:

2023-AR23_00060

First Posted:

Feb 24, 2023

Last Update Posted:

Feb 24, 2023

Last Verified:

Feb 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University Hospital, Angers

fasting

quality of recovery

surgery

Study Results

No Results Posted as of Feb 24, 2023