Bypassing Anesthesiologist Assessment Before Cataract Surgery: a Non Inferiority Study

NCT02903485 | Terminated

• 1 other identifier: JMD_2014-31
• Study Type: interventional
• Target: 578
• Locations: 1 country
• Sites: 1

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.

Conditions

Cataract

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

nurses (intervention arm)

EXPERIMENTAL

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

Other: nurses perform presurgical assessement and surveillance during surgery

anesthetic team (control arm)

ACTIVE COMPARATOR

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

Interventions

nurses perform presurgical assessement and surveillance during surgery OTHER

nurses (intervention arm)

the anesthetic team performs presurgical assessement and surveillance during surgery OTHER

anesthetic team (control arm)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age \> 18 years old
• cataract surgery scheduled with topical anesthetics
• outpatient surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondation Ophtalmologique Adolphe de Rothschild: lead

Study Sites (1)

Fondation Ophtalmologique Adophe de Rothschild

Paris, 75019, France

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Officials

• Jean-Michel Devys, MD

  Fondation Ophtalmologique Adolphe de Rothschild

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2016
• First Posted: September 16, 2016
• Study Start: December 1, 2015
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2018
• Last Updated: December 7, 2018

Record last verified: 2017-11

Locations

FR (1)