Evaluating the impact of standardized handover in major surgery
Morbidity and Mortality in Operating Room: Surgery and Standardized Communication
Assistance Publique - Hôpitaux de Paris · NCT05440331
This study is testing if a new way for anesthetists to share important patient information during major surgery can help reduce serious problems after surgery and improve patient satisfaction.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris (other) |
| Locations | 1 site (Boulogne-Billancourt) |
| Trial ID | NCT05440331 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the effectiveness of a standardized handover protocol using AnesList© among physician anesthetists in the operating room. It focuses on the occurrence of adverse events such as death, serious complications, and rehospitalization within one month post-major surgery. The study will analyze various factors including the quality and duration of the handover, the length of ICU stays, and overall patient satisfaction with the handover process. Additionally, it will evaluate the persistence of using the AnesList© tool six months after the study's conclusion.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 years old requiring major surgery with an ASA score of I-IV.
Not a fit: Patients undergoing minor surgeries or those not requiring a handover between anesthetists may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance patient safety and outcomes following major surgeries by improving communication during handovers.
How similar studies have performed: Previous studies have shown that standardized communication protocols can improve patient outcomes, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient aged \> 18 years; * Patients with score ASA I-IV; * Requiring urgent or planned surgery; * Major surgery (duration of surgery \> 2 hours, requiring a hospital stay of at least 1 night): orthopedics, cardiac, vascular, thoracic, visceral, ENT, plastic surgery; * Handover between two anesthesists defined as a definitive relay between one physician anaesthesist and another in operating room; * Intensive care anesthesists and nurse anaesthetist working in investigator center during the study; * Affiliated to a social security system; * No-opposition to participating to the study. Exclusion Criteria: * Transmission between physician anaesthesist and nurse anaesthetist; * Medical transmission occurs out of anesthesia care out of operating room; * Medical transmission occurs in transitory manner (for example: coffee time, lunch time); * Patients enrolled in an another ongoing study of surgical intervention.
Where this trial is running
Boulogne-Billancourt
- Department of Anesthesia and Intensive Care - Ambroise Paré Hospital - APHP — Boulogne-Billancourt, France (RECRUITING)
Study contacts
- Principal investigator: Dominique FLETCHER, MD, PhD — Department of Anesthesia and Intensive Care - Ambroise Paré Hospital - APHP
- Study coordinator: Dominique FLETCHER, MD, PhD
- Email: dominique.fletcher@aphp.fr
- Phone: +33 (0)661177035
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Major Surgery, Major surgery, Morbility, Mortality, Training in peroperative, Handover, Anaesthetist, Nurse anaesthetist