Evaluation of the Impact of Touch Relaxation in Sedated Intubated Patients Hospitalized in Intensive Care at Niort Hospital
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Centre Hospitalier de Niort
- Enrollment
- 72
- Locations
- 1
- Primary Endpoint
- chemical restraint
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Single (Outcomes Assessor)
Masking Description
It's a person external to the care service and to the randomization process will collect the possible prescription of a chemical restraint or the evolution of this chemical restraint by the resuscitator, in order to maintain the blind.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
control
this arm will not received relaxing touch. It's a control arm
Experimental
this arm will received relaxing touch twice a day
Intervention: this arm will received relaxing touch (hands, feet, head) during 30 minutes twice a day (Other)
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
- self-extubations(1 year)
- 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)
- patient discomfort(T=0, T=30 nimutes, T=60 minutes, T= 90 minutes)
- Ratio chemical restraint use(1 year)