Difficult or Failed Intubation, Reaction Anxiety
Conditions
Keywords
chemical restraint, intensive care, intubation
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.
Interventions
Patients who will be included in this arm will receive massage twice a day of the head (10 minutes), feet (10 minutes) and hands (10 minutes)
Sponsors
Study design
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.
Intervention model description
This study will be conducted in two parallel groups. At the inclusion, each patient will be assigned to one of two groups by randomization; one group will receive the touch and the second group will not receive it will be the control arm.
Eligibility
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| chemical restraint | 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
| Measure | Time frame | Description |
|---|---|---|
| self-extubations | 1 year | Comparison of the proportion of self-extubations between the 2 groups |
| patient discomfort | T=0, T=30 nimutes, T=60 minutes, T= 90 minutes | Comparison of patient discomfort parameters between the 2 groups. The discomfort will be evaluated thank to body expression (unrest) and facial expression according to the BPS scale. The BPS scale is a behavioral pain scale used in intensive care for the sedated and ventilated adult patient. There discomfort parameters will be evaluated immediately after the relaxation touch, 30 min after, 60 min after and 90 min after. The patients included in a experimal group will be relaxation touch twice per day 12 hours apart |
| respiratory rate | T=0, T=30 nimutes, T=60 minutes, T= 90 minutes | Comparison of vital parameters between the 2 groups. Comparison between respiratory rate (/min), cardiac rate (/min), pressur (mmHG), and ventilation mode. Touch could relax patients and thus lower the values of vital parameters. The patients included in a experimal group will be relaxation touch twice per day 12 hours apart |
| Ratio chemical restraint use | 1 year | Ratio per patient corresponding to the number of days with chemical restraint use between inclusion and exclusion/total number of days between inclusion and extubation. |
| cardiac frequency | T=0, T=30 nimutes, T=60 minutes, T= 90 minutes | Comparison of vital parameters between the 2 groups. Comparison between respiratory rate (/min), cardiac rate (/min), pressur (mmHG), and ventilation mode. Touch could relax patients and thus lower the values of vital parameters. The patients included in a experimal group will be relaxation touch twice per day 12 hours apart |
Countries
France