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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05111340
Other study ID # 2017-A02478-45
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 23, 2018
Est. completion date June 12, 2021

Study information

Verified date October 2021
Source Ramsay Générale de Santé
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this study is to set up a pre and postoperative ambulation score on a population of adult patients and undergoing outpatient surgery operated under locoregional anesthesia and sedation.


Recruitment information / eligibility

Status Completed
Enrollment 525
Est. completion date June 12, 2021
Est. primary completion date May 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patient over 18 years-old - Patient undergoing sedation with or without associated local anesthesia - Patient having giver their consent - Patient are benefiting from a social protection insurance - Patient hospitalized as part of the outpatient for ophthalmologic surgery or upper limb surgery, plastic surgery or surgery for implantation of a vascular access device Exclusion Criteria: - Patient whose surgery is performed on the lower limbs - Patient with psychiatric disorders - Patient with dementia - Patient who has already participated in this same study (ex: cataract the second eye is made a few weeks after the first) - Patient's refusal to participate in the study - Protected patients: Adults under guardianship, curatorship or other legal protection, deprived of their liberty by judicial or administrative decision; Pregnant, breastfeeding or parturient woman; Hospitalized without consent.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Perioperative score
Creation and validation of a perioperative walk score. The patient has to answer different items.

Locations

Country Name City State
France Hôpital privé Arras les Bonnettes Arras

Sponsors (2)

Lead Sponsor Collaborator
Ramsay Générale de Santé European Clinical Trial Experts Network

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary The validity of the perioperative walk score The validity of the score will be assessed using the theory of item response (TRI). This theory is based on the correlations between the items of the score. 1 day
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