NCT04787133

Brief Summary

Compare the experience of patients receiving an "optimized" preoperative anesthesia consultation (PAC) performed by a Nurse Anesthetist (supervised by an anesthetist) to those receiving a "standard" CSA ( CSA by an anesthetist alone).

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Feb 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 26, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 8, 2021

Completed
11 months until next milestone

Study Start

First participant enrolled

February 1, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

September 1, 2022

Status Verified

August 1, 2022

Enrollment Period

5 months

First QC Date

January 26, 2021

Last Update Submit

August 31, 2022

Conditions

Keywords

Anesthesia consultationPatient satisfaction

Outcome Measures

Primary Outcomes (1)

  • Assessment of patient satisfaction with a perioperative anesthetic evaluation

    Patient satisfaction will be assess within 48h after surgery using the "Evaluation du Vécu de l'Anesthésie" or "EVAN" (EVAN-G for EVAN-General anesthesia or EVAN-LR for EVAN-locoregional anesthesia). The EVAN-G includes 26 items; six specific scores (Attention, Information, Discomfort, Privacy, Waiting and Pain) and one global index score. The EVAN-LR comprises 19 items; five specific scores (Attention, Information, Discomfort, Waiting, and Pain) and one global index score. Specific and global index scores were linearly transformed to a 0-100 scale, with 100 indicating the best possible level of satisfaction and 0 indicating the worst.

    48 hours

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients who will have an anesthesia consultation on one of the randomized shifts

You may qualify if:

  • Patient over 18 years old
  • Must benefit from an anesthesia consultation for general or regional anesthesia for scheduled surgery, whatever it is.
  • Express consent to participate in the study
  • Affiliate or beneficiary of a social security scheme

You may not qualify if:

  • Patient benefiting from a legal protection measure
  • Pregnant or breastfeeding woman
  • Patient unable to understand and read French, as well as to complete a self-administered questionnaire
  • Patient with mental retardation with impaired judgment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Fondation Adolphe de Rothschild

Paris, Île-de-France Region, 75019, France

Location

MeSH Terms

Conditions

Patient Satisfaction

Condition Hierarchy (Ancestors)

Treatment Adherence and ComplianceHealth BehaviorBehavior
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2021

First Posted

March 8, 2021

Study Start

February 1, 2022

Primary Completion

July 1, 2022

Study Completion

September 1, 2022

Last Updated

September 1, 2022

Record last verified: 2022-08

Locations