- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07488468
Quality Improvement Project to Reduce Preoperative Fasting Times Before Elective Procedures
Study Overview
Status
Detailed Description
Traditionally, surgical patients are instructed to fast for prolonged periods to reduce the risk of pulmonary aspiration. International guidelines recommend fasting from clear liquids for 2 hours prior to elective procedures, yet real-world fasting often extends to 6-10 hours, which can impair patient well-being and may contribute to complications such as dehydration, hypoglycemia, postoperative nausea and vomiting, and delirium-particularly in older or frail patients. This quality improvement project follows the Plan-Do-Study-Act (PDSA) framework.
Plan: Review evidence and decide to implement "drink until called to the OR." Do: Train anesthesiology staff, adapt local SOPs, provide oral patient instructions, and introduce fasting instruction cards for patients and staff.
Study: Record and analyze fasting times and fluid intake prior to anesthesia induction; assess effectiveness and adjust strategies.
Act: Add further staff education, posters, and short instructional screencasts to reinforce the updated fasting guidance.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Marit Habicher, Dr.
- Phone Number: +4964198544401
- Email: Marit.Habicher@chiru.med.uni-giessen.de
Study Contact Backup
- Name: Brigitte Clausen
- Email: Brigitte.Clausen@chiru.med.uni-giessen.de
Study Locations
-
-
-
Giessen, Germany, 35390
- Recruiting
- Justus Liebig University Giessen, University Hospital Giessen and Marburg
-
Contact:
- Michael Sander, PhD
- Phone Number: +4964198544401
-
Contact:
- Marit Habicher, Dr.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- All patients elective surgery or intervention requiring with anesthesiology care general anesthesia, regional anesthesia, sedation, or anesthesiology stand-by
Exclusion Criteria:
- Already sedated, intubated, and mechanically ventilated patients
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
Control group
before implementation new fasting time program
|
|
Intervention group
after implementation a new fasting time program
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Preoperative fasting time (clear liquids and solids)
Time Frame: At anesthesia induction.
|
Time interval between last intake of clear liquids and anesthesia induction.
Time interval between last solid meal and anesthesia induction.
|
At anesthesia induction.
|
|
PACU length of stay
Time Frame: PACU admission to discharge.
|
PACU length of stay
|
PACU admission to discharge.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Preoperative fasting time (clear liquids and solids)
Time Frame: At anesthesia induction (pre vs post implementation periods).
|
Time interval between last intake of clear liquids and anesthesia induction.
Time interval between last solid meal and anesthesia induction.
|
At anesthesia induction (pre vs post implementation periods).
|
|
Patient satisfaction regarding fasting
Time Frame: immediately after the intervention/procedure/surgery up to 1 day postoperatively
|
Patient satisfaction regarding fasting (questionnaire)
|
immediately after the intervention/procedure/surgery up to 1 day postoperatively
|
|
Perioperative complications
Time Frame: Intraoperative and immediate postoperative period (PACU).
|
Perioperative complications (e.g., nausea, vomiting, regurgitation/aspiration)
|
Intraoperative and immediate postoperative period (PACU).
|
|
Postoperative pulmonary and gastrointestinal complications
Time Frame: During the hospital stay up to 30 days
|
Pneumonia,Aspiration, nausea and vomiting
|
During the hospital stay up to 30 days
|
|
Delirium occurrence
Time Frame: During the hospital stay, up to 30 days
|
Occurance of postoperative delir
|
During the hospital stay, up to 30 days
|
|
Hospital length of stay and in-hospital mortality
Time Frame: Until hospital discharge / up to 30 days
|
Hospital length of stay and in-hospital mortality
|
Until hospital discharge / up to 30 days
|
|
Acute kidney injury (AKI)
Time Frame: Within the first 3 postoperative days.
|
Acute kidney injury (AKI) (creatinine increase)
|
Within the first 3 postoperative days.
|
|
ICU/IMC admission
Time Frame: During the hospital stay up to 30 days
|
ICU/IMC admission (planned/unplanned) and duration
|
During the hospital stay up to 30 days
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Nervous System Diseases
- Mental Disorders
- Postoperative Complications
- Pathologic Processes
- Signs and Symptoms, Digestive
- Confusion
- Neurobehavioral Manifestations
- Neurocognitive Disorders
- Vomiting
- Nausea
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Delirium
- Postoperative Nausea and Vomiting
Other Study ID Numbers
- AZ 178/25
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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