Bypassing Anesthesiologist Assessment Before Cataract Surgery: a Non Inferiority Study

Study Overview
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Brief Summary
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This study aims to demonstrate that presurgical assessement of patients' risk factors and surveillance during surgery, both performed by nurses, are not inferior to anesthetic team's care, concerning the rate of complications in cataract surgery with topical anesthesia. The nurse performs the triage of patients based on a chart of risk factors assessment. The triage, according to the presence or not of risk factors, leads to patients' care by an anesthetic team (medical anesthesist for pre-surgical assessement and anesthetic nurse for surveillance during surgery) or to patients' pre-surgical assessement and surveillance during surgery both performed only by nurses. In the control group, all patients are taken care of by an aesthetic team, with medical pre surgical assessement and surveillance during surgery both performed by anesthetic nurses.

Conditions
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Cataract

Intervention / Treatment
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* Other: nurses perform presurgical assessement and surveillance during surgery
* Other: the anesthetic team performs presurgical assessement and surveillance during surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age > 18 years old cataract surgery scheduled with topical anesthetics outpatient surgery Exclusion Criteria: presurgical nurse assessment leading to the need for the anesthetic staff presence during surgery general, peribulbar or other locoregional anesthesia required by patient's condition concomitant surgery planified (glaucoma, vitrectomy…) patient's refusal to participate in the study no health insurance coverage

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 |
| --- | --- |
| Experimental: nurses (intervention arm)<br>for patients without risk factors, the anesthetic team is not involved in patients' care | Other: nurses perform presurgical assessement and surveillance during surgery<br> <br> |
| Active Comparator: anesthetic team (control arm)<br>the anesthetic team is involved in every patient's care (with or without risk factors) | Other: the anesthetic team performs presurgical assessement and surveillance during surgery<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of complications | complications occuring in operating theatre include systolic blood pressure > 200 mmHg or < 80 mmHg, diastolic blood pressure > 110 mmHg, heart rate < 45/mn for at least 1 mn, oxygen saturation (SpO2) <90% for at least 1 mn, impossibility to start or to pursue surgery because of patient condition. | through study completion, up to 6 months |