An International Prospective, Observational, Multi-centre Study on the Duration of Pre-operative Liquid Fasting

NCT ID: NCT06527703

Last Updated: 2025-07-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 5100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-11-01
• Study Completion Date: 2025-01-30

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.

Conditions

Diabetes Mellitus; Hypertension; Ischaemic Heart Disease; Comorbidities and Coexisting Conditions; Fasting; Fasting, Time Restricted

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

preoperative liquid fasting duration in adult patients undergoing elective surgery

Adult patients scheduled for elective procedures and either requiring general anaesthetic, regional anaesthesia or sedation will be eligible to participate. The necessary institutional approvals will be obtained.

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

no intervention

Intervention Type: OTHER

Patients have to answer a questionnaire. The following data will be recorded:

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:_______________________

preoperative liquid fasting time

Adult patients scheduled for elective procedures and either requiring general anaesthetic, regional anaesthesia or sedation will be eligible to participate. The necessary institutional approvals will be obtained.

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

no intervention

Intervention Type: OTHER

Patients have to answer a questionnaire. The following data will be recorded:

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:_______________________

Interventions

no intervention

Patients have to answer a questionnaire. The following data will be recorded:

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:_______________________

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Puerta de Hierro University Hospital

OTHER

Sponsor Role: collaborator

Mater Dei Hospital, Malta

OTHER

Sponsor Role: lead

Responsible Party

Anne Marie Camilleri Podesta'

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Federico Bilotta, Prof

Role: PRINCIPAL_INVESTIGATOR

Anne Marie Camilleri Podesta, Dr

Role: PRINCIPAL_INVESTIGATOR

Mater Dei Hospital

Locations

Mater Dei Hospital

San Ġiljan, Msida, Malta

Countries

Malta

Other Identifiers

ThirstStudy

Identifier Type: -

Identifier Source: org_study_id