Early Mobilisation and Relational Touch Practice on Intubated Patients of Intensive Care Unit

NCT05903378 | Not Yet Recruiting

• 2 other identifiers: APHP2301192023-A00328-37
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

41.3% of patients hospitalized in intensive care express feeling anxiety when they are systematically questioned. Ventilatory weaning is one of the moments of anxiety for the patient. While being conscious he must tolerate invasive ventilation. The early mobilization of patients in intensive care must be started early, within 24-48 hours, after the patient wakes up. Early mobilization is part of the weaning process from invasive mechanical ventilation in intensive care. It is recommended to reduce it to use relaxation therapies. Several studies have assessed the impact of relational touch in conscious or unconscious patients in intensive care. The SRLF consensus conference in 2010 recommends the use of massage for anxiolytic purposes. This study aims to assess the impact of relational touch versus standard care on anxiety during the first bedside session, in intubated intensive care patients ventilated for at least 48 hours and presenting with RASS (Richmond agitation sedation scale). ) from 0 to -1. The study will aussi assess the impact of relational touch versus standard care on the following patient parameters:

• Evaluation of caregiver anxiety with the Spielberger inventory before and after the session
• Increasing the duration of the bedside session;
• Variations in pain, assessed by the Behavioral Pain Scale (BPS) at the end of the session;
• The level of agitation/vigilance at the beginning and at the end of the session with the Richmond agitation-sedation scale (RASS);
• Induced variations in blood pressure;
• Induced variations in oxygen saturation;
• The variations induced on the respiratory rate;
• The variations induced on the heart rate;
• The need to prescribe psychotropic drugs on the day of the first bedside;
• Reduction in the number of days of invasive mechanical ventilation between the first bedside session and discharge from intensive care unit (maximum D28 after the first bedside session). This is a national, multicenter, cluster, randomized, controlled trial with 4-stage stepped-wedge design (1:1:1:1 randomization), phase III, superiority, open-label, comparing systematic practice relational touch by the paramedical team during bedside sessions, versus standard care (without relational touch). The benefit is above all for the patient with a better experience of bedside sessions and a reduction in ventilation time, therefore bed rest, leading to a reduction in decubitus complications. The expected economic benefit involves the reduction of decubitus complications and therefore their cost and the reduction of hospitalization times in intensive care.

Conditions

Ventilation Therapy

Keywords

Ventilation Therapy; ICU; relational touch

Outcome Measures

Primary Outcomes (1)

• Evaluation of patients' anxiety

  With the Face Anxiety Scale, anxiety lever of patients will be assessed.

  at baseline

Study Arms (2)

Relational touch group

EXPERIMENTAL

Touch in care aims to improve the patient's perception of potentially painful or anxiety-provoking acts of care. It is based on techniques of skin contact, developing and deepening.

Other: Relational touch practice

Standard care group

NO INTERVENTION

Routine care without relational touch practice.

Interventions

Relational touch practice OTHER

Relational touch practice during the first bedside session. Touch in care aims to improve the patient's perception of potentially painful or anxiety-provoking acts of care. It is based on techniques of skin contact, developing and deepening.

Relational touch group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patient ventilated invasively for at least 48 hours, RASS between 0 and -1 with early mobilization prescribed but not performed.

You may not qualify if:

• Patient needing help from another person to mobilizing
• Patient with an unstable fracture
• Patient with a recent laparotomy (less than 10 days)
• Patient under judicial protection measures
• Patient on catecholamines
• Pregnant or breastfeeding woman
• Non-communicating patient due to neuropsychiatric pathology
• Patient benefiting from a process of palliative care or moribund patient whose estimated life expectancy is less than 30 days
• Strict bed rest order
• Fraction inspired oxygen (FIO2) \>50%
• Body mass index \> 40 Kg/m2
• Patient having an epidural with motor impairment.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• GIRCI IDF: collaborator

Study Sites (1)

ICU, Ambroise Paré Hospital - APHP

Boulogne-Billancourt, 92100, France

Location

Study Officials

• Katia Nadaud, degree of nurse

  ICU, Ambroise Paré Hospital - APHP

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Katia Nadaud, degree of nurse

CONTACT

+ 33 1 49 09 44 52; katia.nadaud-Moreau@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2023
• First Posted: June 15, 2023
• Study Start: December 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: April 6, 2025

Record last verified: 2025-03

Locations

FR (1)