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Clinical Trials/NCT06527703
NCT06527703
Completed
Not Applicable

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

Mater Dei Hospital, Malta1 site in 1 country5,100 target enrollmentNovember 1, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diabetes Mellitus
Sponsor
Mater Dei Hospital, Malta
Enrollment
5100
Locations
1
Primary Endpoint
The primary objective of this observational study is to determine the actual duration of preoperative liquid fasting time.
Status
Completed
Last Updated
9 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 1, 2024
End Date
January 30, 2025
Last Updated
9 months ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Mater Dei Hospital, Malta
Responsible Party
Principal Investigator
Principal Investigator

Anne Marie Camilleri Podesta'

Dr

Mater Dei Hospital, Malta

Eligibility Criteria

Inclusion Criteria

  • Age ≥ 18 years
  • Patients undergoing elective surgery
  • Written informed consent

Exclusion Criteria

  • Age \< 18 years
  • Urgent and emergency surgery

Outcomes

Primary Outcomes

The primary objective of this observational study is to determine the actual duration of preoperative liquid fasting time.

Time Frame: Data will be collected on the same day among the participating centres. This is planned for the 23rd October 2024

Adult patients scheduled for elective procedures and either requiring general anaesthetic, regional anaesthesia or sedation will be eligible to participate. After obtaining consent and screening for eligibility, the patients will answer a short questionnaire regarding their last liquid intake.

Study Sites (1)

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