Bypassing Anesthesiologist Assessment Before Cataract Surgery: a Non Inferiority Study (CATARIDE)

Fondation Ophtalmologique Adolphe de Rothschild

Status: Terminated

Conditions: Cataract

Treatments: Other: nurses perform presurgical assessement and surveillance during surgery; Other: the anesthetic team performs presurgical assessement and surveillance during surgery

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT02903485

JMD_2014-31

Details and patient eligibility

About

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.

Enrollment: 578 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

578 participants in 2 patient groups

nurses (intervention arm)

Experimental group

Description:

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

Treatment:

Other: nurses perform presurgical assessement and surveillance during surgery

anesthetic team (control arm)

Active Comparator group

Description:

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

Treatment:

Other: the anesthetic team performs presurgical assessement and surveillance during surgery