Major SurgeryHIATUSNCT05440331
Morbidity and Mortality: Surgery and Standardized Transmission in Operating Room
An observational study of Major Surgery, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The primary objective of the study is to evaluate the efficacy of standard handover with AnesList© between physician anesthesists in operating room, for a complete transmission for a patient, on the occurence of event as death, serious complications or rehospitalization in month of postoperative after major surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Major Surgery
- What is being tested?
- Training with AnesList©
- How many people
- 1,120 participants
- Where
- 1 siteFrance
- Study dates
- 8 Sep 2023to Oct 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients requiring urgent or planned major surgery (duration of surgery > 2 hours, requiring a hospital stay of at least 1 night): orthopedics, cardiac, vascular, thoracic, visceral, ENT, plastic surgery; with 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Department of Anesthesia and Intensive Care - Ambroise Paré Hospital - APHP
Boulogne-Billancourt, 92100
About this study
Official title: Morbidity and Mortality in Operating Room: Surgery and Standardized Communication
The primary objective of the study is to evaluate the efficacy of standard handover with AnesList© between physician anesthesists in operating room, for a complete transmission for a patient, on the occurence of event as death, serious complications or rehospitalization in month of postoperative after major surgery.
Read the detailed description
The secondary objectives are:
- to analysis the impact of the transmission on:
- the occurence of different events: re-hospitalization, serious complications, death at one month;
- the duration of initial ICU stay and of hospitalization;
- the duration of the transmission;
- the quality of the transmission by the physician leaving operating room.
- to evaluate the condition of the transmission
- to study the persistence of the use of the AnesList© at 6 months after the end of inclusions in the center
- to evaluate the satisfaction on AnesList© and on the training with the tool and the obstacles of its utilization
- to evaluate the morbility-mortality in the centers of the centers before, during and 6 months after the beginning of the study.
- Conditions
- Major Surgery
- Being tested
- Training with AnesList©
- Keywords
- Major surgery, Morbility, Mortality, Training in peroperative, Handover, Anaesthetist, Nurse anaesthetist
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training with AnesList©Other
Training with AnesList© as tool
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental group with training after randomization immediately Receives: Other: Training with AnesList© | |
| Control group with delayed training | Control group with training: the training will delayed from time of randomization Receives: Other: Training with AnesList© | |
| Control group without training | Control group without training |
What is being measured
The primary outcome is the main question the study is designed to answer.
The occurence of adverse events
Death, serious complications and re-hospitalization will be noted in order to evaluate the efficacy of standardized transmission with AnesList©.
Measured: at 1 month
Secondary outcomes (7)
The duration of ICU stay
The length of initial ICU stay will be noted.
Measured: through study completion, an average of 18 months
The duration of hospitalization
The length of initial hospitalization will be noted.
Measured: through study completion, an average of 18 months
Evaluate of the condition of transmission
By the presence or intervention of anaesthetics-nurse, recorded or not the transmission in medical files.
Measured: through study completion, an average of 18 months
Utilization of the AnesList© by anaesthesists at 6 months
Only for intervention group: use on cell phone or with printed form: the use will be noted.
Measured: at 6 months
Quality of medical transmission
Scale will be noted by anaesthesists between 0 and 22: 20% of recorded transmission will be noted.
Measured: through study completion, an average of 18 months
Interaction with study nurse
The study nurse will evaluate the existence and composite of the interaction between the anesthesist who receiving the transmission and the nurse.
Measured: through study completion, an average of 18 months
Morbi-mortality
The method of chronological series will be used to analysis the morbi-mortality in investigator center.
Measured: through study completion, an average of 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2022
- Study start8 Sep 2023
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Major SurgeryStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- 1,120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dominique FLETCHER, MD, PhD, Principal investigator, Department of Anesthesia and Intensive Care - Ambroise Paré Hospital - APHPAicha KASSOUL, MD, Study director, Department of Anesthesia and Intensive Care - Ambroise Paré Hospital - APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05440331
- Sponsor's protocol ID
- APHP210992
- Other IDs
- 2022-A01109-34
- Acronym
- HIATUS
- Status last verified
- Sep 2025
- First submitted
- 17 Jun 2022
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sedgwick P, Greenwood N. Understanding the Hawthorne effect. BMJ. 2015 Sep 4;351:h4672. doi: 10.1136/bmj.h4672. No abstract available.
PubMed 26341898Jullia M, Tronet A, Fraumar F, Minville V, Fourcade O, Alacoque X, LeManach Y, Kurrek MM. Training in intraoperative handover and display of a checklist improve communication during transfer of care: An interventional cohort study of anaesthesia residents and nurse anaesthetists. Eur J Anaesthesiol. 2017 Jul;34(7):471-476. doi: 10.1097/EJA.0000000000000636.
PubMed 28437261Haynes AB, Weiser TG, Berry WR, Lipsitz SR, Breizat AH, Dellinger EP, Herbosa T, Joseph S, Kibatala PL, Lapitan MC, Merry AF, Moorthy K, Reznick RK, Taylor B, Gawande AA; Safe Surgery Saves Lives Study Group. A surgical safety checklist to reduce morbidity and mortality in a global population. N Engl J Med. 2009 Jan 29;360(5):491-9. doi: 10.1056/NEJMsa0810119. Epub 2009 Jan 14.
PubMed 19144931
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Morbidity and Mortality in Operating Room: Surgery and Standardized Communication
- ClinicalTrials.gov ID
- NCT05440331
- Acronym / sponsor ID
- HIATUS / APHP210992
- Conditions
- Major Surgery
- Keywords
- Major surgery, Morbility, Mortality, Training in peroperative, Handover, Anaesthetist, Nurse anaesthetist
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,120 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 8 Sep 2023 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 30 Jun 2022 (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.
The primary objective of the study is to evaluate the efficacy of standard handover with AnesList© between physician anesthesists in operating room, for a complete transmission for a patient, on the occurence of event as death, serious complications or rehospitalization in month of postoperative after major surgery.
Detailed description
The secondary objectives are:
- to analysis the impact of the transmission on:
- the occurence of different events: re-hospitalization, serious complications, death at one month;
- the duration of initial ICU stay and of hospitalization;
- the duration of the transmission;
- the quality of the transmission by the physician leaving operating room.
- to evaluate the condition of the transmission
- to study the persistence of the use of the AnesList© at 6 months after the end of inclusions in the center
- to evaluate the satisfaction on AnesList© and on the training with the tool and the obstacles of its utilization
- to evaluate the morbility-mortality in the centers of the centers before, during and 6 months after the beginning of the study.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental group | – | Other: Training with AnesList©Experimental group with training after randomization immediately |
| Control group with delayed training | – | Other: Training with AnesList©Control group with training: the training will delayed from time of randomization |
| Control group without training | – | –Control group without training |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients requiring urgent or planned major surgery (duration of surgery > 2 hours, requiring a hospital stay of at least 1 night): orthopedics, cardiac, vascular, thoracic, visceral, ENT, plastic surgery; with 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.
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Training with AnesList©Training with AnesList© as tool | Other | Control group with delayed training, Experimental group |
Primary outcome
The occurence of adverse events
Time frame: at 1 month
Death, serious complications and re-hospitalization will be noted in order to evaluate the efficacy of standardized transmission with AnesList©.
7 secondary outcomes
The duration of ICU stay
Time frame: through study completion, an average of 18 months
The duration of hospitalization
Time frame: through study completion, an average of 18 months
Evaluate of the condition of transmission
Time frame: through study completion, an average of 18 months
Utilization of the AnesList© by anaesthesists at 6 months
Time frame: at 6 months
Quality of medical transmission
Time frame: through study completion, an average of 18 months
Interaction with study nurse
Time frame: through study completion, an average of 18 months
Morbi-mortality
Time frame: through study completion, an average of 18 months
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 19 Nov 2025.
- Background: PubMed 26341898Sedgwick P, Greenwood N. Understanding the Hawthorne effect. BMJ. 2015 Sep 4;351:h4672. doi: 10.1136/bmj.h4672. No abstract available.
- Background: PubMed 28437261Jullia M, Tronet A, Fraumar F, Minville V, Fourcade O, Alacoque X, LeManach Y, Kurrek MM. Training in intraoperative handover and display of a checklist improve communication during transfer of care: An interventional cohort study of anaesthesia residents and nurse anaesthetists. Eur J Anaesthesiol. 2017 Jul;34(7):471-476. doi: 10.1097/EJA.0000000000000636.
- Background: PubMed 19144931Haynes AB, Weiser TG, Berry WR, Lipsitz SR, Breizat AH, Dellinger EP, Herbosa T, Joseph S, Kibatala PL, Lapitan MC, Merry AF, Moorthy K, Reznick RK, Taylor B, Gawande AA; Safe Surgery Saves Lives Study Group. A surgical safety checklist to reduce morbidity and mortality in a global population. N Engl J Med. 2009 Jan 29;360(5):491-9. doi: 10.1056/NEJMsa0810119. Epub 2009 Jan 14.
- Individual participant dataSharing planned: No
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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.
Dominique FLETCHER, MD, PhD principal investigator
Department of Anesthesia and Intensive Care - Ambroise Paré Hospital - APHP
Aicha KASSOUL, MD study director
Department of Anesthesia and Intensive Care - Ambroise Paré Hospital - APHP
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 Major Surgery, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 8 inclusion and 4 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 19 Nov 2025. 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 France. 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 Dominique FLETCHER, MD, PhD (+33 (0)661177035, dominique.fletcher@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The occurence of adverse events (time frame: at 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05440331, which also lists 3 linked publications.
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 19 Nov 2025.