Preoperative FastingNCT07488468
Quality Improvement Project to Reduce Preoperative Fasting Times Before Elective Procedures
An observational study of Preoperative Fasting and Perioperative Patient Comfort / Quality of Care, run by University of Giessen at 1 site in Germany.
Trial summary
This single-center quality improvement project evaluates preoperative fasting times before elective procedures requiring anesthesiology care. The project aims to reduce prolonged fasting for clear fluids by implementing a local standard operating procedure (SOP) allowing patients to drink clear liquids until being… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Preoperative Fasting, Perioperative Patient Comfort / Quality of Care, Postoperative Nausea and Vomiting (PONV)
- How many people
- 1,000 participants
- Where
- 1 siteGermany
- Study dates
- 30 Jan 2026to 30 Jul 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population includes all patients undergoing elective procedures requiring anesthesiology care (general anesthesia, regional anesthesia, sedation, or anesthesiology standby) at University Hospital Giessen during the predefined pre- and post-implementation data collection periods. Patients who are already sedated, intubated, and mechanically ventilated at the time of anesthesia induction are excluded.
Who may be able to join
- All patients elective surgery or intervention requiring with anesthesiology care general anesthesia, regional anesthesia, sedation, or anesthesiology stand-by
Who cannot join
- Already sedated, intubated, and mechanically ventilated patients
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brigitte Clausen contact
Germany1 site, 1 recruiting
- Recruiting
Justus Liebig University Giessen, University Hospital Giessen and Marburg
Giessen, 35390
Michael Sander, PhD, +4964198544401
Marit Habicher, Dr.
About this study
This single-center quality improvement project evaluates preoperative fasting times before elective procedures requiring anesthesiology care. The project aims to reduce prolonged fasting for clear fluids by implementing a local standard operating procedure (SOP) allowing patients to drink clear liquids until being called to the operating room ("drink until called"), supported by staff education and fasting instruction cards. Fasting times and selected perioperative outcomes will be assessed before and after implementation.
Read the 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.
- Conditions
- Preoperative Fasting, Perioperative Patient Comfort / Quality of Care, Postoperative Nausea and Vomiting (PONV), Postoperative Pulmonary Complications, Delirium
- Keywords
- Preoperative fasting, clear liquids, quality improvement
- Medical subject headings
- Postoperative Nausea and Vomiting, Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Control group | before implementation new fasting time program | |
| Intervention group | after implementation a new fasting time program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preoperative fasting time (clear liquids and solids)
Time interval between last intake of clear liquids and anesthesia induction. Time interval between last solid meal and anesthesia induction.
Measured: At anesthesia induction.
PACU length of stay
PACU length of stay
Measured: PACU admission to discharge.
Secondary outcomes (8)
Preoperative fasting time (clear liquids and solids)
Time interval between last intake of clear liquids and anesthesia induction. Time interval between last solid meal and anesthesia induction.
Measured: At anesthesia induction (pre vs post implementation periods).
Patient satisfaction regarding fasting
Patient satisfaction regarding fasting (questionnaire)
Measured: immediately after the intervention/procedure/surgery up to 1 day postoperatively
Perioperative complications
Perioperative complications (e.g., nausea, vomiting, regurgitation/aspiration)
Measured: Intraoperative and immediate postoperative period (PACU).
Postoperative pulmonary and gastrointestinal complications
Pneumonia,Aspiration, nausea and vomiting
Measured: During the hospital stay up to 30 days
Delirium occurrence
Occurance of postoperative delir
Measured: During the hospital stay, up to 30 days
Hospital length of stay and in-hospital mortality
Hospital length of stay and in-hospital mortality
Measured: Until hospital discharge / up to 30 days
Acute kidney injury (AKI)
Acute kidney injury (AKI) (creatinine increase)
Measured: Within the first 3 postoperative days.
ICU/IMC admission
ICU/IMC admission (planned/unplanned) and duration
Measured: During the hospital stay up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2026
- Study start30 Jan 2026
- Primary completion30 May 2026 (estimated)
- Study completion30 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preoperative FastingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Giessen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07488468
- Sponsor's protocol ID
- AZ 178/25
- Status last verified
- Mar 2026
- First submitted
- 16 Feb 2026
- Last updated
- 23 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality Improvement Project to Reduce Preoperative Fasting Times Before Elective Procedures
- ClinicalTrials.gov ID
- NCT07488468
- Acronym / sponsor ID
- AZ 178/25
- Conditions
- Preoperative Fasting, Perioperative Patient Comfort / Quality of Care, Postoperative Nausea and Vomiting (PONV), Postoperative Pulmonary Complications, Delirium
- Keywords
- Preoperative fasting, clear liquids, quality improvement
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University of GiessenUniversity, hospital or other
- Study start
- 30 Jan 2026 (actual)
- Primary completion
- 30 May 2026 (estimated)
- Study completion
- 30 Jul 2026 (estimated)
- First posted
- 23 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This single-center quality improvement project evaluates preoperative fasting times before elective procedures requiring anesthesiology care. The project aims to reduce prolonged fasting for clear fluids by implementing a local standard operating procedure (SOP) allowing patients to drink clear liquids until being called to the operating room ("drink until called"), supported by staff education and fasting instruction cards. Fasting times and selected perioperative outcomes will be assessed before and after implementation.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | – | –before implementation new fasting time program |
| Intervention group | – | –after implementation a new fasting time program |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population includes all patients undergoing elective procedures requiring anesthesiology care (general anesthesia, regional anesthesia, sedation, or anesthesiology standby) at University Hospital Giessen during the predefined pre- and post-implementation data collection periods. Patients who are already sedated, intubated, and mechanically ventilated at the time of anesthesia induction are excluded.
Key inclusion criteria (1 listed)
- All patients elective surgery or intervention requiring with anesthesiology care general anesthesia, regional anesthesia, sedation, or anesthesiology stand-by
Key exclusion criteria (1 listed)
- Already sedated, intubated, and mechanically ventilated patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
PACU length of stay
Time frame: PACU admission to discharge.
PACU length of stay
8 secondary outcomes
Preoperative fasting time (clear liquids and solids)
Time frame: 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
Perioperative complications
Time frame: Intraoperative and immediate postoperative period (PACU).
Postoperative pulmonary and gastrointestinal complications
Time frame: During the hospital stay up to 30 days
Delirium occurrence
Time frame: 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
Acute kidney injury (AKI)
Time frame: Within the first 3 postoperative days.
ICU/IMC admission
Time frame: During the hospital stay up to 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Brigitte Clausen contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preoperative Fasting and Perioperative Patient Comfort / Quality of Care, run by University of Giessen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marit Habicher, Dr. (+4964198544401, Marit.Habicher@chiru.med.uni-giessen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preoperative fasting time (clear liquids and solids) (time frame: At anesthesia induction.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2026.