Bypassing Anesthesiologist Assessment Before Cataract Surgery: a Non Inferiority Study (CATARIDE)
Primary Purpose
Cataract
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
nurses perform presurgical assessement and surveillance during surgery
the anesthetic team performs presurgical assessement and surveillance during surgery
Sponsored by
About this trial
This is an interventional health services research trial for Cataract
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
Sites / Locations
- Fondation Ophtalmologique Adophe de Rothschild
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
nurses (intervention arm)
anesthetic team (control arm)
Arm Description
for patients without risk factors, the anesthetic team is not involved in patients' care
the anesthetic team is involved in every patient's care (with or without risk factors)
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02903485
First Posted
September 8, 2016
Last Updated
December 6, 2018
Sponsor
Fondation Ophtalmologique Adolphe de Rothschild
1. Study Identification
Unique Protocol Identification Number
NCT02903485
Brief Title
Bypassing Anesthesiologist Assessment Before Cataract Surgery: a Non Inferiority Study
Acronym
CATARIDE
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Terminated
Study Start Date
December 2015 (Actual)
Primary Completion Date
January 2018 (Actual)
Study Completion Date
January 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondation Ophtalmologique Adolphe de Rothschild
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
578 (Actual)
8. Arms, Groups, and Interventions
Arm Title
nurses (intervention arm)
Arm Type
Experimental
Arm Description
for patients without risk factors, the anesthetic team is not involved in patients' care
Arm Title
anesthetic team (control arm)
Arm Type
Active Comparator
Arm Description
the anesthetic team is involved in every patient's care (with or without risk factors)
Intervention Type
Other
Intervention Name(s)
nurses perform presurgical assessement and surveillance during surgery
Intervention Type
Other
Intervention Name(s)
the anesthetic team performs presurgical assessement and surveillance during surgery
Primary Outcome Measure Information:
Title
Incidence of complications
Description
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.
Time Frame
through study completion, up to 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Michel Devys, MD
Organizational Affiliation
Fondation Ophtalmologique Adolphe de Rothschild
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fondation Ophtalmologique Adophe de Rothschild
City
Paris
ZIP/Postal Code
75019
Country
France
12. IPD Sharing Statement
Learn more about this trial
Bypassing Anesthesiologist Assessment Before Cataract Surgery: a Non Inferiority Study
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