Bypassing Anesthesiologist Assessment Before Cataract Surgery: a Non Inferiority Study

Not Applicable

Terminated

• Conditions: Cataract
• Interventions: Other: the anesthetic team performs presurgical assessement and surveillance during surgery; Other: nurses perform presurgical assessement and surveillance during surgery

• Registration Number: NCT02903485
• Lead Sponsor: Fondation Ophtalmologique Adolphe de Rothschild

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-12
• Study First Submitted: 2016-09-08
• Study First Submitted QC: 2016-09-12
• Study First Posted: 2016-09-16
• Status Verified: 2017-11
• Primary Completion: 2018-01
• Study Completion: 2018-01
• Last Update Submitted: 2018-12-06
• Last Update Posted: 2018-12-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 578

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
anesthetic team (control arm)	the anesthetic team performs presurgical assessement and surveillance during surgery	the anesthetic team is involved in every patient's care (with or without risk factors)
nurses (intervention arm)	nurses perform presurgical assessement and surveillance during surgery	for patients without risk factors, the anesthetic team is not involved in patients' care

Primary Outcome Measures

Name	Time	Method
Incidence of complications	through study completion, up to 6 months	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.

Trial Locations

Locations (1)

Fondation Ophtalmologique Adophe de Rothschild; 🇫🇷 Paris, France