Centralised Anesthesic Monitoring in the Surgery of the Ocular Anterior Segment: Non Inferiority Study
- Conditions
- Ambulatory Surgical ProceduresOcular Anterior Segment Surgery
- Interventions
- Other: Health care organization (anesthetic surveillance)
- Registration Number
- NCT02037009
- Lead Sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 900
- adult patient scheduled for ocular anterior segment surgery (cataract, glaucoma, pterygium) with local or topic anesthesia
- patient refusing to participate in the study or without health insurance
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description centralised monitoring surveillance Health care organization (anesthetic surveillance) 1 anesthetic nurse is posted at a centralised monitoring station outside of the 3 operating rooms, while another one can intervene inside the 3 operating rooms whenever needed. Interphones allow communication between the monitoring station and the operating rooms.
- Primary Outcome Measures
Name Time Method Anesthetic potential impact on surgery conditions during surgical procedure Incidence rate of at least 1 of the following events, during surgery:
* blood pressure \> 200 mmHg on 2 consecutive measures (automatic measure every 3 minutes)
* cardiac frequency \< 45/min for at least 1 mn
* SaO2 \<85% for at least 1 mn
* poor operating conditions (rated ≤ 7 by the surgeon, on a numeric scale from 0 to 10=excellent conditions). Assessment at the exit of operating room.
- Secondary Outcome Measures
Name Time Method patient pre-surgical stress baseline auto-assessment of stress level using a 0 to 10 (maximum stress) scale
interventions of the back-up anesthetic nurse during surgical procedure mean number of interventions of the back-up anesthetic nurse during the procedures proportion of surgical procedures requiring at least one intervention of the nurse
incidence rate of each of the events included in the primary outcome during surgical procedure incidence rate of blood pressure \> 200 mmHg on 2 consecutive measures (automatic measure every 3 minutes) incidence rate of cardiac frequency \< 45/min for at least 1 mn incidence rate of SaO2 \<85% for at least 1 mn incidence rate of poor operating conditions (rated \< 7 by the surgeon, on a numeric scale from 0 to 10 (excellent conditions)
working conditions at the end of a working day auto-assessment of working conditions by the anesthetic nurses, on a 0 to 10 (excellent) scale and on a 0 to 10 (completely safe) scale
pain during surgical procedure within 10 minutes after surgery retrospective auto-assessment of patient pain using a 0 to 10 (maximum pain) scale
patient agitation within 10 minutes after surgery assessed by the surgeon using a 0 to 10 (very agitated) scale
patient satisfaction within 10 minutes after surgery auto-assessment of patient satisfaction using a 0 to 10 (fully satisfied) scale
operating conditions within 10 minutes after surgery auto-assessment by the surgeon of the operating conditions, on a 0 to 10 (excellent conditions) scale and on a 0 to 10 (completely safe) scale
Trial Locations
- Locations (1)
Fondation Ophtalmologique Adolphe de Rothschild
🇫🇷Paris, Ile de France, France