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Clinical Trials/NCT06346119
NCT06346119
Recruiting
N/A

Evaluation of the Impact of Touch Relaxation in Sedated Intubated Patients Hospitalized in Intensive Care at Niort Hospital

Centre Hospitalier de Niort1 site in 1 country72 target enrollmentFebruary 27, 2023

Overview

Phase
N/A
Intervention
Not specified
Conditions
Reaction Anxiety
Sponsor
Centre Hospitalier de Niort
Enrollment
72
Locations
1
Primary Endpoint
chemical restraint
Status
Recruiting
Last Updated
8 months ago

Overview

Brief Summary

This is a randomized prospective study. This objective is the impact of "relaxing touch" on the use of chemical restraint for patients in intensive care from the lifting of sedation until extubation.

Registry
clinicaltrials.gov
Start Date
February 27, 2023
End Date
December 31, 2025
Last Updated
8 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Male or female over 18 years of age
  • Intubated and sedated man or woman
  • Extubation within 48 hours
  • Intubation of more than 48 hours in total
  • Patient in intensive care at Niort hospital
  • The trusted person or referent accepting the patient's participation
  • Patient affiliated to the social security system

Exclusion Criteria

  • Known pregnancy
  • Patient who refused to participate in the study after the fact
  • Patients under long-term antidepressant treatment (treatment longer than 3 months)
  • Patients under guardianship or curatorship
  • Patient deprived of liberty
  • Skin lesions on the hands/feet/head (wounds, erythema, burns, bedsores, phlyctenes)
  • Inclusion in another clinical study

Outcomes

Primary Outcomes

chemical restraint

Time Frame: 1 year

Comparison of the proportion of patients who received chemical restraint during the sedation release phase until extubation between the two groups (experimental and control arms)

Secondary Outcomes

  • respiratory rate(T=0, T=30 nimutes, T=60 minutes, T= 90 minutes)
  • cardiac frequency(T=0, T=30 nimutes, T=60 minutes, T= 90 minutes)
  • self-extubations(1 year)
  • patient discomfort(T=0, T=30 nimutes, T=60 minutes, T= 90 minutes)
  • Ratio chemical restraint use(1 year)

Study Sites (1)

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