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

December 6, 2018 updated by: Fondation Ophtalmologique Adolphe de Rothschild

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

578

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75019
        • Fondation Ophtalmologique Adophe de Rothschild

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: nurses (intervention arm)
for patients without risk factors, the anesthetic team is not involved in patients' care
Other: nurses perform presurgical assessement and surveillance during surgery
Active Comparator: anesthetic team (control arm)
the anesthetic team is involved in every patient's care (with or without risk factors)
Other: the anesthetic team performs presurgical assessement and surveillance during surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of complications
Time Frame: 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.
through study completion, up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2015

Primary Completion (Actual)

January 1, 2018

Study Completion (Actual)

January 1, 2018

Study Registration Dates

First Submitted

September 8, 2016

First Submitted That Met QC Criteria

September 12, 2016

First Posted (Estimate)

September 16, 2016

Study Record Updates

Last Update Posted (Actual)

December 7, 2018

Last Update Submitted That Met QC Criteria

December 6, 2018

Last Verified

November 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JMD_2014-31

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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