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

Difficult or Failed Intubation Clinical Trial

— ETDR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06346119
• Other study ID #: PI-2023-01
• Status: Recruiting
• Phase: N/A
• Start date: February 27, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: March 2024
• Source: Centre Hospitalier de Niort
• Contact: Jean Marc M. Le Guevel, Nurse coordinator
• Phone: 549783254
• Email: jean-marc.leguevel[@]ch-niort.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: December 31, 2025
• Est. primary completion date: January 5, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Difficult or Failed Intubation

Intervention

Other:
• this arm will received relaxing touch (hands, feet, head) during 30 minutes twice a day
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)

Locations

Country	Name	City	State
France	Centre Hospitalier de Niort	Niort

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier de Niort

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	chemical restraint	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)	1 year
Secondary	self-extubations	Comparison of the proportion of self-extubations between the 2 groups	1 year
Secondary	patient discomfort	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	T=0, T=30 nimutes, T=60 minutes, T= 90 minutes
Secondary	respiratory rate	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	T=0, T=30 nimutes, T=60 minutes, T= 90 minutes
Secondary	Ratio chemical restraint use	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.	1 year
Secondary	cardiac frequency	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	T=0, T=30 nimutes, T=60 minutes, T= 90 minutes