Bypassing Anesthesiologist Assessment Before Cataract Surgery: a Non Inferiority Study
NCT ID: NCT02903485
Last Updated: 2018-12-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
578 participants
INTERVENTIONAL
2015-12-31
2018-01-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
SINGLE
Study Groups
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nurses (intervention arm)
for patients without risk factors, the anesthetic team is not involved in patients' care
nurses perform presurgical assessement and surveillance during surgery
anesthetic team (control arm)
the anesthetic team is involved in every patient's care (with or without risk factors)
the anesthetic team performs presurgical assessement and surveillance during surgery
Interventions
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nurses perform presurgical assessement and surveillance during surgery
the anesthetic team performs presurgical assessement and surveillance during surgery
Eligibility Criteria
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Inclusion Criteria
* cataract surgery scheduled with topical anesthetics
* outpatient surgery
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Fondation Ophtalmologique Adolphe de Rothschild
NETWORK
Responsible Party
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Principal Investigators
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Jean-Michel Devys, MD
Role: PRINCIPAL_INVESTIGATOR
Fondation Ophtalmologique Adolphe de Rothschild
Locations
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Fondation Ophtalmologique Adophe de Rothschild
Paris, , France
Countries
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Other Identifiers
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JMD_2014-31
Identifier Type: -
Identifier Source: org_study_id