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Recruiting NCT07488468

Quality Improvement Project to Reduce Preoperative Fasting Times Before Elective Procedures

Observational Preoperative Fasting Perioperative Patient Comfort / Quality of Care Postoperative Nausea and Vomiting (PONV) Postoperative Pulmonary Complications

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Preoperative Fasting, Perioperative Patient Comfort / Quality of Care, Postoperative Nausea and Vomiting (PONV), Postoperative Pulmonary Complications. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Primary outcome measures

  • Preoperative fasting time (clear liquids and solids) [Time frame: At anesthesia induction.]
  • PACU length of stay [Time frame: PACU admission to discharge.]
Secondary outcome measures (8)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-control

Study locations

Germany · 1 center
  • Justus Liebig University Giessen, University Hospital Giessen and Marburg — Giessen

Identifiers

NCT: NCT07488468 · AZ 178/25

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗