SACHS: Centralised Anesthesic Monitoring in the Surgery of the Ocular Anterior Segment: Non Inferiority Study
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| No Intervention: Usual surveillance surveillance performed by a qualified nurse, present in the operating room during the whole anesthesia. |
|
| Experimental: centralised monitoring 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. |
Other: Health care organization (anesthetic surveillance)
|
Outcome Measures
Primary Outcome Measures
- 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
- 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
- patient pre-surgical stress [baseline]
auto-assessment of stress level using a 0 to 10 (maximum stress) 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 satisfaction [within 10 minutes after surgery]
auto-assessment of patient satisfaction using a 0 to 10 (fully satisfied) scale
- 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)
- patient agitation [within 10 minutes after surgery]
assessed by the surgeon using a 0 to 10 (very agitated) 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
- 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
Other Outcome Measures
- revision surgery [24 hours after baseline]
incidence rate of revision surgery within 24 hours
- efficiency of the centralised monitoring of anesthesic surveillance [during surgical procedure]
assessment of costs
- patient baseline pain [baseline]
auto-assessment of patient pain before surgery on a 0 to 10 (maximum pain) scale
Eligibility Criteria
Criteria
Inclusion Criteria:
- adult patient scheduled for ocular anterior segment surgery (cataract, glaucoma, pterygium) with local or topic anesthesia
Exclusion Criteria:
- patient refusing to participate in the study or without health insurance
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Fondation Ophtalmologique Adolphe de Rothschild | Paris | Ile de France | France | 75019 |
Sponsors and Collaborators
- Fondation Ophtalmologique Adolphe de Rothschild
- Ministry of Health, France
Investigators
- Principal Investigator: Jean-Michel DEVYS, MD, Fondation Ophtalmologique Adolphe de Rothschild
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SC_JMD_2013-1