Bypassing Anesthesiologist Assessment Before Cataract Surgery: a Non Inferiority Study

NCT ID: NCT02903485

Last Updated: 2018-12-07

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 578 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2018-01-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

nurses (intervention arm)

for patients without risk factors, the anesthetic team is not involved in patients' care

Group Type: EXPERIMENTAL

nurses perform presurgical assessement and surveillance during surgery

Intervention Type: OTHER

anesthetic team (control arm)

the anesthetic team is involved in every patient's care (with or without risk factors)

Group Type: ACTIVE_COMPARATOR

the anesthetic team performs presurgical assessement and surveillance during surgery

Intervention Type: OTHER

Interventions

nurses perform presurgical assessement and surveillance during surgery

Intervention Type: OTHER

the anesthetic team performs presurgical assessement and surveillance during surgery

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondation Ophtalmologique Adolphe de Rothschild

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean-Michel Devys, MD

Role: PRINCIPAL_INVESTIGATOR

Fondation Ophtalmologique Adolphe de Rothschild

Locations

Fondation Ophtalmologique Adophe de Rothschild

Paris, , France

Countries

France

Other Identifiers

JMD_2014-31

Identifier Type: -

Identifier Source: org_study_id