Back to resultsSecuring the Immediate Perioperative Walk: Creating and Validating a Score. (Déambu)
Primary Purpose
Wandering Behavior, Anesthesia
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Perioperative score
Sponsored by
About this trial
This is an interventional other trial for Wandering Behavior
Eligibility Criteria
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.
Sites / Locations
- Hôpital privé Arras les Bonnettes
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Adult patients undergoing sedation with or without associated local anesthesia
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05111340
First Posted
October 27, 2021
Last Updated
October 27, 2021
Sponsor
Ramsay Générale de Santé
Collaborators
European Clinical Trial Experts Network
1. Study Identification
Unique Protocol Identification Number
NCT05111340
Brief Title
Securing the Immediate Perioperative Walk: Creating and Validating a Score.
Acronym
Déambu
Official Title
Securing the Immediate Perioperative Walk: Creating and Validating a Score.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
April 23, 2018 (Actual)
Primary Completion Date
May 1, 2021 (Actual)
Study Completion Date
June 12, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ramsay Générale de Santé
Collaborators
European Clinical Trial Experts Network
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wandering Behavior, Anesthesia
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
525 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Adult patients undergoing sedation with or without associated local anesthesia
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Perioperative score
Intervention Description
Creation and validation of a perioperative walk score. The patient has to answer different items.
Primary Outcome Measure Information:
Title
The validity of the perioperative walk score
Description
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.
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Hôpital privé Arras les Bonnettes
City
Arras
ZIP/Postal Code
62012
Country
France
12. IPD Sharing Statement
Learn more about this trial
Securing the Immediate Perioperative Walk: Creating and Validating a Score.
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