Surgical Emergency Flows and Delays in Admission to the Operating Room

Surgery Clinical Trial

— ACUTE-FLOW  

Official title:

Flows of Emergency Surgery and Delay in Admission to the Operating Room: a Multicenter Prospective Observational Study in France

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04585529
• Other study ID #: NI2020/01
• Status: Completed
• Start date: October 5, 2020
• Est. completion date: March 15, 2021

Study information

• Verified date: May 2021
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1149
• Est. completion date: March 15, 2021
• Est. primary completion date: March 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Emergencies
• Postoperative Complications
• Surgery

Locations

Country	Name	City	State
France	University hospital	Angers
France	Clinique	Antony
France	Beaujon Hospital	Clichy
France	Henri Mondor Hospital	Créteil
France	University Hospital	Grenoble
France	University hospital	Lille
France	Edouard Herriot Hospital	Lyon
France	Hôpital sud	Lyon
France	HEGP	Paris
France	University Hospital	Strasbourg

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Lille	Société Française d'Anesthésie et de Réanimation

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of OR admission delay (delay = aTTS / iTTS > 1)	hours	30 days
Secondary	OR Admission delay according to the three organizational model	hours	30 days
Secondary	OR Admission delay according to the period of work (day, night, and week-end)	hours	30 days
Secondary	OR Admission delay according to the NEST classification	hours	30 days
Secondary	delays related to organisational causes	hours	30 days
Secondary	delays related to material causes	hours	30 days
Secondary	delays related to human causes	hours	30 days
Secondary	Impact of the delay on ICU length of stay	days	30 days
Secondary	Impact of the delay on hospital length of stay	days	30 days
Secondary	Impact of the delay on mortality		30 days
Secondary	Impact of the delay on morbidity		30 days