SurgeryACUTE-FLOWNCT04585529
Surgical Emergency Flows and Delays in Admission to the Operating Room
An observational study of Surgery and Emergencies, run by University Hospital, Lille at 10 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgery, Emergencies, Postoperative Complications
- How many people
- 1,149 participants
- Where
- 10 sitesFrance
- Study dates
- 5 Oct 2020to 15 Mar 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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: 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).
Who may be able to join
- 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).
Who cannot join
- obstetrics
- interventional radiology
- endoscopies
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
France10 sites
University hospital
Angers
Clinique
Antony
Beaujon Hospital
Clichy
Henri Mondor Hospital
Créteil
University Hospital
Grenoble
University hospital
Lille
Edouard Herriot Hospital
Lyon
Hôpital sud
Lyon
HEGP
Paris
University Hospital
Strasbourg
About this study
Official title: 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.
- Conditions
- Surgery, Emergencies, Postoperative Complications
- Keywords
- delay, organization
- Medical subject headings
- Emergencies, Postoperative Complications
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of OR admission delay (delay = aTTS / iTTS > 1)
hours
Measured: 30 days
Secondary outcomes (10)
OR Admission delay according to the three organizational model
hours
Measured: 30 days
OR Admission delay according to the period of work (day, night, and week-end)
hours
Measured: 30 days
OR Admission delay according to the NEST classification
hours
Measured: 30 days
delays related to organisational causes
hours
Measured: 30 days
delays related to material causes
hours
Measured: 30 days
delays related to human causes
hours
Measured: 30 days
Impact of the delay on ICU length of stay
days
Measured: 30 days
Impact of the delay on hospital length of stay
days
Measured: 30 days
Impact of the delay on mortality
Measured: 30 days
Impact of the delay on morbidity
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start5 Oct 2020
- Primary completion15 Mar 2021
- Study completion15 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,149 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- Société Française d'Anesthésie et de Réanimation
- Responsible party
- Sponsor
- Investigators
- Delphine GARRIGUE, MD, Principal investigator, University Hospital, Lille, FranceBenoit TAVERNIER, MD, PhD, Study chair, University Hospital, Lille, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04585529
- Sponsor's protocol ID
- NI2020/01
- Acronym
- ACUTE-FLOW
- Status last verified
- May 2021
- First submitted
- 5 Oct 2020
- Last updated
- 26 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Flows of Emergency Surgery and Delay in Admission to the Operating Room: a Multicenter Prospective Observational Study in France
- ClinicalTrials.gov ID
- NCT04585529
- Acronym / sponsor ID
- ACUTE-FLOW / NI2020/01
- Conditions
- Surgery, Emergencies, Postoperative Complications
- Keywords
- delay, organization
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,149 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- Société Française d'Anesthésie et de Réanimation
- Study start
- 5 Oct 2020 (actual)
- Primary completion
- 15 Mar 2021 (actual)
- Study completion
- 15 Mar 2021 (actual)
- First posted
- 14 Oct 2020 (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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (3 listed)
- obstetrics
- interventional radiology
- endoscopies
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
Incidence of OR admission delay (delay = aTTS / iTTS > 1)
Time frame: 30 days
hours
10 secondary outcomes
OR Admission delay according to the three organizational model
Time frame: 30 days
OR Admission delay according to the period of work (day, night, and week-end)
Time frame: 30 days
OR Admission delay according to the NEST classification
Time frame: 30 days
delays related to organisational causes
Time frame: 30 days
delays related to material causes
Time frame: 30 days
delays related to human causes
Time frame: 30 days
Impact of the delay on ICU length of stay
Time frame: 30 days
Impact of the delay on hospital length of stay
Time frame: 30 days
Impact of the delay on mortality
Time frame: 30 days
Impact of the delay on morbidity
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2021.
Related trials for Surgery
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
RecruitingObservational study
Comparison of Hemodynamic Responses During Anesthesia Induction Using Eleveld and Schnider
Spinal (Fusion) Surgery, Total Intravenous Anesthesia
RecruitingPhase 1
Serial Amnioinfusions as Regenerative Therapy for Pulmonary Hypoplasia
Renal Failure Congenital, Congenital Renal Anomaly Nos
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
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. This study is not recruiting at the moment.
Delphine GARRIGUE, MD principal investigator
University Hospital, Lille, France
Benoit TAVERNIER, MD, PhD study chair
University Hospital, Lille, France
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgery and Emergencies, run by University Hospital, Lille at 10 sites 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 4 inclusion and 3 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: finished, as of the sponsor's last update on 26 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of OR admission delay (delay = aTTS / iTTS > 1) (time frame: 30 days). 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 26 May 2021.