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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Ambulatory Surgical Procedures, Ocular Anterior Segment Surgery

Intervention / Treatment
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* Other: Health care organization (anesthetic surveillance)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual surveillance<br>surveillance performed by a qualified nurse, present in the operating room during the whole anesthesia. | |
| Experimental: centralised monitoring surveillance<br>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)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anesthetic potential impact on surgery conditions | 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. | during surgical procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| interventions of the back-up anesthetic nurse | 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 | during surgical procedure | 
| patient pre-surgical stress | auto-assessment of stress level using a 0 to 10 (maximum stress) scale | baseline | 
| pain during surgical procedure | retrospective auto-assessment of patient pain using a 0 to 10 (maximum pain) scale | within 10 minutes after surgery | 
| patient satisfaction | auto-assessment of patient satisfaction using a 0 to 10 (fully satisfied) scale | within 10 minutes after surgery | 
| incidence rate of each of the events included in the primary outcome | 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) | during surgical procedure | 
| patient agitation | assessed by the surgeon using a 0 to 10 (very agitated) scale | within 10 minutes after surgery | 
| operating conditions | 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 | within 10 minutes after surgery | 
| working conditions | 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 | at the end of a working day |