Clinical trial NCT06527703: An International Prospective, Observational, Multi-centre Study on the Duration of Pre-operative Liquid Fasting
Official title: International Prospective, Observational, Multi-centre, Cross-sectional Study on the Duration of Pre-operative Liquid Fasting
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Diabetes Mellitus
Hypertension
Ischaemic Heart Disease
Comorbidities and Coexisting Conditions
Fasting
Fasting, Time Restricted
Keywords: Preoperative fluid fasting time
Lead sponsor: Mater Dei Hospital, Malta
Sponsor class: OTHER
Collaborators: name: Puerta de Hierro University Hospital
First posted: 2024-07-30
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients scheduled for elective procedures and either requiring general anaesthetic, regional anaesthesia or sedation will be eligible to participate.

Data will be collected on the same day among the participating centres. After obtaining consent and screening for eligibility, the patients will answer a short questionnaire regarding their last liquid intake.

The type of procedure, type of anaesthesia and time of arrival in the holding bay / operating room as well as the date and time at which clear fluids were last consumed will be recorded

Brief summary: The investigators will be performing an international prospective, observational, multi-centre, cross-sectional study to determine the actual duration of preoperative liquid fasting time in European patients.

Research has shown that prolonged fasting, particularly for liquids, is likely harmful to patients before, during, and after an operation. Harm from prolonged fasting for liquids includes dehydration, dysregulated blood sugar levels, increased stress response, and postoperative complications. Recent studies show an average preoperative fasting time for liquids that are significantly longer than necessary.

Reducing fasting time is associated with improved patient well-being, a smoother perioperative course, shorter hospital stays, cost savings, and enhanced environmental sustainability.

The investigators hypothesize that excessive preoperative fasting is still common practice in most European countries and would like to investigate the actual length of liquid fasting practices amongst patients in Europe, to determine whether the current guidelines are being followed.

Detailed description: The investigators will be performing an international prospective, observational, multi-centre, cross-sectional study to determine the actual duration of preoperative liquid fasting time in European patients. The investigators have interest and commitment from 12 countries and hope to recruit more hospitals in the coming weeks.

Research has shown that prolonged fasting, particularly for liquids, is likely harmful to patients before, during, and after an operation. Harm from prolonged fasting for liquids includes dehydration, dysregulated blood sugar levels, increased stress response, and postoperative complications. Recent studies show an average preoperative fasting time for liquids that are significantly longer than necessary.

In the pilot study the investigators conducted a few weeks ago, the average preoperative liquid fasting time was 12 hours instead of the recommended 2 hours. Reducing fasting time is associated with improved patient well-being, a smoother perioperative course, shorter hospital stays, cost savings, and enhanced environmental sustainability. The investigators hypothesise that excessive preoperative fasting is still common practice in most European countries and would like to investigate the actual length of liquid fasting practices amongst patients in Europe, to determine whether the current guidelines are being followed. This will give further insight to colleagues and encourage healthcare professionals to follow the fasting guidelines from the European Society of Anaesthesia and Intensive Care.

The methodology and other details can be found in the study protocol and the other documents. Adult patients scheduled for elective procedures and either requiring general anaesthetic, regional anaesthesia or sedation will be eligible to participate. Data will be collected on the same day among the participating centres and the target date is the 23rd October 2024.

After obtaining consent and screening for eligibility, the patients will answer a short questionnaire regarding their last liquid intake. The following data will be collected:

Patient Number:

Informed Consent: ☐ yes ☐ no

Screening for eligibility Age \>= 18 years: ☐ yes ☐ no

Gender: ☐ M ☐ F Patient undergoing elective procedure: ☐ yes ☐ no Time of arrival in the operating room _________________

Procedure:

General surgery ☐ Orthopaedic surgery ☐ Neurosurgery ☐ Cardiac surgery ☐ Vascular ☐ Urology ☐ ENT/ dental/ maxillo-facial ☐ Obstetrics and Gynaecology surgery ☐ Ophthalmic surgery ☐ Non-operating room anaesthesia ☐ Endoscopy ☐ Other ____________________

Type of Anaesthesia (choose 1):

GA ☐ Sedation ☐ Regional ☐

Date and Time at which clear fluids were last consumed:_______________________

The questionnaire will last less than 5 minutes.

This questionnaire is very simple and no patient identifiable data will be recorded on the data collection tool.

Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years
2. Patients undergoing elective surgery
3. Written informed consent

Exclusion Criteria:

1. Age \< 18 years
2. Urgent and emergency surgery

Primary outcomes:
measure: The primary objective of this observational study is to determine the actual duration of preoperative liquid fasting time.
timeFrame: Data will be collected on the same day among the participating centres. This is planned for the 23rd October 2024
Secondary outcomes:
Other outcomes:
Locations:
city: St Julian's
country: Malta
facility: Mater Dei Hospital
state: Msida
Study officials:
name: Federico Bilotta, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Mater Dei Hospital
name: Anne Marie Camilleri Podesta, Dr
role: PRINCIPAL_INVESTIGATOR
References: