- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04585529
Surgical Emergency Flows and Delays in Admission to the Operating Room (ACUTE-FLOW)
May 25, 2021 updated by: University Hospital, Lille
Flows of Emergency Surgery and Delay in Admission to the Operating Room: a Multicenter Prospective Observational Study in France
French hospitals treat non-elective surgery according to three organizational models: in a dedicated multi-specialty emergency operative room (OR), in a dedicated OR within a specialized surgical platform or in any available OR from a list of non-dedicated OR.
Some triage algorithms for the classification of non-elective surgery have been described but are not routinely applied.
The rate of delay in the management of non-elective surgery in France is not known.
Reducing this delay decreased mortality and morbidity in urgent surgery (McIsaac D, et al., CMAJ 2017).
Optimizing the flow of non-elective surgery represents a major challenge.
The main objective of this study is to determine the rate of delay in admission to the OR in emergency surgery through a multicenter prospective observational study in France.
All patients requiring urgent surgical management (<72 hours) will be included.
The ideal time for surgery was previously defined by surgeons according to the NEST classification (NEST 1: within minutes; NEST 2: < 1 hour; NEST 3: < 4 hours; NEST 4: < 12 hours; NEST 5: < 48 hours; NEST 6: < 72 hours).
For each patient, the ratio between the observed time (actual Time To Surgery [aTTS] ) and the ideal time (ideal Time To Surgery [iTTS]) will be determined.
The delay is identified by aTTS/iTTS ratio >1.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
1149
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Angers, France
- University Hospital
-
Antony, France
- Clinique
-
Clichy, France
- Beaujon Hospital
-
Créteil, France
- Henri Mondor Hospital
-
Grenoble, France
- University Hospital
-
Lille, France
- University Hospital
-
Lyon, France
- Edouard Herriot Hospital
-
Lyon, France
- Hopital Sud
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Paris, France
- HEGP
-
Strasbourg, France
- University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients aged at least 18 years hospitalized and requiring non-elective surgery.
Non-elective means that the surgery must ideally be performed within 72 hours. Patients may be coming in via the emergency department or may already be hospitalized when requiring surgical intervention.
Anthony).
Description
Inclusion Criteria:
any patient meeting the Following two criteria
- at least 18 ys old
- decision for unplanned surgery (which should be performed within 72 hours according to the protocol)
- in one of the following hospitals: Lille University hospital, Grenoble University hospital, Strasbourg University hospital, Paris University hospitals (Européen Georges Pompidou, Beaujon, H. Mondor), Lyon University hospital (Hôpital E. Herriot, Lyon Sud), Angers University hospital, Anthony Private hospital).
Exclusion Criteria:
- obstetrics
- interventional radiology
- endoscopies
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of OR admission delay (delay = aTTS / iTTS > 1)
Time Frame: 30 days
|
hours
|
30 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
OR Admission delay according to the three organizational model
Time Frame: 30 days
|
hours
|
30 days
|
OR Admission delay according to the period of work (day, night, and week-end)
Time Frame: 30 days
|
hours
|
30 days
|
OR Admission delay according to the NEST classification
Time Frame: 30 days
|
hours
|
30 days
|
delays related to organisational causes
Time Frame: 30 days
|
hours
|
30 days
|
delays related to material causes
Time Frame: 30 days
|
hours
|
30 days
|
delays related to human causes
Time Frame: 30 days
|
hours
|
30 days
|
Impact of the delay on ICU length of stay
Time Frame: 30 days
|
days
|
30 days
|
Impact of the delay on hospital length of stay
Time Frame: 30 days
|
days
|
30 days
|
Impact of the delay on mortality
Time Frame: 30 days
|
30 days
|
|
Impact of the delay on morbidity
Time Frame: 30 days
|
30 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Delphine GARRIGUE, MD, University Hospital, Lille, France
- Study Chair: Benoit TAVERNIER, MD, PhD, University Hospital, Lille, France
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
October 5, 2020
Primary Completion (ACTUAL)
March 15, 2021
Study Completion (ACTUAL)
March 15, 2021
Study Registration Dates
First Submitted
October 5, 2020
First Submitted That Met QC Criteria
October 12, 2020
First Posted (ACTUAL)
October 14, 2020
Study Record Updates
Last Update Posted (ACTUAL)
May 26, 2021
Last Update Submitted That Met QC Criteria
May 25, 2021
Last Verified
May 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NI2020/01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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