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NCT Number: NCT06527703

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

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

Exclusion criteria

  • Age < 18 years
  • Urgent and emergency surgery

Treatment and study plan

No intervention

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:_______________________

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Mater Dei Hospital, Malta

Other

Collaborators

  • Puerta de Hierro University Hospital

Registry information

Official study title

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

Acronym: THIRST

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Jul 30, 2024
Registry last updated
Jul 9, 2025

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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