Ignite Creation Date:
2024-10-25 @ 8:02 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06527703
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-25
Brief Title:
An International Prospective Observational Multi-centre Study on the Duration of Pre-operative Liquid Fasting
Sponsor:
None
Organization:
None
Study Overview
Official Title:
International Prospective Observational Multi-centre Cross-sectional Study on the Duration of Pre-operative Liquid Fasting
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
THIRST
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None