Bypassing Anesthesiologist Assessment Before Cataract Surgery: a Non Inferiority Study

Cataract Clinical Trial

— CATARIDE  

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02903485
• Other study ID #: JMD_2014-31
• Status: Terminated
• Phase: N/A
• Start date: December 2015
• Est. completion date: January 2018

Study information

• Verified date: November 2017
• Source: Fondation Ophtalmologique Adolphe de Rothschild
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 578
• Est. completion date: January 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cataract

Intervention

Other:
• nurses perform presurgical assessement and surveillance during surgery

• the anesthetic team performs presurgical assessement and surveillance during surgery

Locations

Country	Name	City	State
France	Fondation Ophtalmologique Adophe de Rothschild	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Fondation Ophtalmologique Adolphe de Rothschild

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of complications	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.	through study completion, up to 6 months