NCT02037009

Centralised Anesthesic Monitoring in the Surgery of the Ocular Anterior Segment: Non Inferiority Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 900 (actual)
• Sponsor: Fondation Ophtalmologique Adolphe de Rothschild · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

In France, cataract surgery is the most frequent surgical procedure, performed with local anesthesia and most often very light techniques using eye-drops. Technical improvements of surgical and anesthesic procedures have led many countries to implement alternative surveillance procedures. In France, it is mandatory that the persons in charge of anesthetic surveillance (doctors or nurses) should be qualified in anesthesia. In this study, the investigators aim to assess the feasibility and safety of a centralised monitoring station outside of the operating rooms, as an alternative to the presence of 1 anesthetic nurse in each operating room.

Detailed description

In their hospital, the investigators will study the following alternatives for the anesthetic surveillance of the 3 operating rooms where surgery of the ocular anterior segment is performed: 1) the usual procedure, with the presence of 3 anesthetic nurses (1 in each operating room) and 2) a new organization with an anesthetic nurse checking a centralised monitoring station and a back-up anesthetic nurse ready to intervene inside the 3 operating rooms whenever needed. The 2 procedures will be successively implemented during 3 to 4 sequences, until the number of surgical procedures statistically required have been studied. The investigators aim to demonstrate that the centralised monitored surveillance does not put the patients at risk more often than the current surveillance procedure.

Conditions

• Ambulatory Surgical Procedures
• Ocular Anterior Segment Surgery

Interventions

Type	Name	Description
OTHER	Health care organization (anesthetic surveillance)

Timeline

• Start date: 2013-11-01
• Primary completion: 2014-04-01
• Completion: 2014-08-01
• First posted: 2014-01-15
• Last updated: 2026-01-06

Locations

1 site across 1 country: France