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Bypassing Anesthesiologist Assessment Before Cataract Surgery: a Non Inferiority Study

NCT02903485 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 578

Last updated 2018-12-07

No results posted yet for this study

Summary

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

  • Cataract

Interventions

OTHER

nurses perform presurgical assessement and surveillance during surgery

OTHER

the anesthetic team performs presurgical assessement and surveillance during surgery

Sponsors & Collaborators

  • Fondation Ophtalmologique Adolphe de Rothschild

    lead NETWORK

Principal Investigators

  • Jean-Michel Devys, MD · Fondation Ophtalmologique Adolphe de Rothschild

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2018-01-31
Completion
2018-01-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02903485 on ClinicalTrials.gov