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

Sponsor

Ramsay Générale de Santé (Other)

Overall Status

Completed

CT.gov ID

NCT05111340

Collaborator

European Clinical Trial Experts Network (Other)

525

Enrollment

Location

Arm

37.7

Actual Duration (Months)

13.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Wandering Behavior Anesthesia	Behavioral: Perioperative score	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

525 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Apr 23, 2018

Actual Primary Completion Date :

May 1, 2021

Actual Study Completion Date :

Jun 12, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Adult patients undergoing sedation with or without associated local anesthesia	Behavioral: Perioperative score Creation and validation of a perioperative walk score. The patient has to answer different items.

Arm

Intervention/Treatment

Experimental: Adult patients undergoing sedation with or without associated local anesthesia

Behavioral: Perioperative score

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

Outcome Measures

Primary Outcome Measures

The validity of the perioperative walk score [1 day]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hôpital privé Arras les Bonnettes	Arras		France	62012

Sponsors and Collaborators

Ramsay Générale de Santé
European Clinical Trial Experts Network

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ramsay Générale de Santé

ClinicalTrials.gov Identifier:

NCT05111340

Other Study ID Numbers:

2017-A02478-45

First Posted:

Nov 8, 2021

Last Update Posted:

Nov 8, 2021

Last Verified:

Oct 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Wandering Behavior

Study Results

No Results Posted as of Nov 8, 2021