Securing the Immediate Perioperative Walk: Creating and Validating a Score.

NCT05111340 | Completed

• 1 other identifier: 2017-A02478-45
• Study Type: interventional
• Target: 525
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Wandering Behavior; Anesthesia

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Adult patients undergoing sedation with or without associated local anesthesia

EXPERIMENTAL

Behavioral: Perioperative score

Interventions

Perioperative score BEHAVIORAL

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

Adult patients undergoing sedation with or without associated local anesthesia

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ramsay Générale de Santé: lead
• European Clinical Trial Experts Network: collaborator

Study Sites (1)

Hôpital privé Arras les Bonnettes

Arras, 62012, France

Location

MeSH Terms

Conditions

Wandering Behavior

Condition Hierarchy (Ancestors)

Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2021
• First Posted: November 8, 2021
• Study Start: April 23, 2018
• Primary Completion: May 1, 2021
• Study Completion: June 12, 2021
• Last Updated: November 8, 2021

Record last verified: 2021-10

Locations

FR (1)