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Completed

NCT Number: NCT05743803

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

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Key information

Conditions

Fasting Behavior Feeding Behavior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Angers

Angers, 49000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Sensititization campaign on preoperative fasting rules

Other
  • 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.

Primary outcomes

  1. Fasting time

    Time frame: Before surgery

    Liquid and solid fasting time before surgery (minutes)

Secondary outcomes

  1. Preoperative oral carbohydrate loading

    Time frame: 2 hours preoperative period

    Rate of oral cardbohydrate intake in the 2 hours preoperative period (percentage)

  2. Fasting exceeding 12 hours

    Time frame: Before surgery

    Rate of fasting duration superior to 12 hours (liquid or solid) (percentage)

  3. Preoperative anxiety

    Time frame: Before surgery

    Scale of preoperative anxiety from 0 (no anxiety) to 10 (maximum anxiety possible)

  4. Preoperative discomfort

    Time frame: Before surgery

    Scale of preoperative disomfort from 0 (no discomfort) to 10 (maximum discomfort possible)

  5. Feeling of thirst

    Time frame: Before surgery

    Qualitative scale of preoperative thirst (none, moderate, significant)

  6. Feeling of hunger

    Time frame: Before surgery

    Qualitative scale of preoperative hunger (none, moderate, significant)

  7. Preoperative nausea or vomiting

    Time frame: Before surgery

    Rate of nausea or vomit in the preoperative period (percentage)

  8. Rate of postoperative nausea or vomiting

    Time frame: Day of surgery

    Rate of nausea or vomit during the post-operative period (percentage)

  9. Patient satisfaction toward communication and explanation about preoperative fasting.

    Time frame: Day of surgery

    Binary answer (yes or no)

  10. Post-operative quality of recovery

    Time frame: Day 1 after surgery

    French Quality of Recovery 15 score (

  11. Length of stay

    Time frame: Maximum 30 days follow up

    Length of stay (days)

  12. Post-operative surgical complication

    Time frame: Maximum 30 days follow up

    Clavien-dindo classification from 0 (no complication) to 5 (death)

Sponsors and collaborators

Lead sponsor

University Hospital, Angers

Other Gov

Registry information

Official study title

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

Acronym: BreakFast

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Feb 24, 2023
Registry last updated
Sep 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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