Clinical and Economic Comparison of 2 Methods of Intubation Tube Fixation : AnchorFastTM Versus Current Cord Fixation
NCT Number: NCT06533436
Acronym: AnchorDon
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Intubation Complication|Eschar
Interventions: PROCEDURE: Corded tube care|DEVICE: Tube care attached by AnchorFast|OTHER: Caregiver's evaluation on each tube fixation
Sponsor: Hopital Foch
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 250
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-07
Completion Date: 2025-07
Locations: Hôpital Foch, Suresnes, 92150, France

Summary:
The aim of this study is to assess the benefits of using the Anchorfast device in reducing complications associated with intubation tube fixation, in terms of the rate of pressure ulcer development, the rate of intubation tube mobilization and the rate of VAP occurrence. If the hypothesis is confirmed, this project would enable the caregivers to optimize the current practice in the interests of both patients and caregivers. That's why the investigators have designed a real-life study, and will also be looking at the effect of care load on and caregiver satisfaction.

Primary Outcome Measures: Comparison of induced pressure sores, Evaluate the change in the incidence rate of eschars (grade 1 or higher according to the National Pressure Ulcer Advisory Panel 1998 classification) induced by fixation of the intubation tube with the AnchorFastTM device compared with the cord fixation cord fixation technique., 16 months
Secondary Outcome Measures: Patient safety regarding the stability of the intubation : number of repositionning, Compare tube attachment stability between the 2 groups : Every day, as part of routine care for intubated patients, the correct position of the tube is recorded and checked. Each repositioning of the intubation tube is also recorded., 16 months|Patient safety regarding the risk of accidental extubation, Compare the number of accidental extubation between the 2 groups, 16 months|Patient safety regarding ventilator-associated pneumonia, Compare the rate of ventilator-associated pneumonia (VAP) between the 2 groups, 16 months|Patient safety regarding intubation-related complications, Evaluate the occurrence of intubation-related complications, 16 months|Impact on nursing staff care load, Comparing the care load between the 2 groups (Nursing Activity Score) . The scale comprises 7 categories for a total of 23 items: basic activities (monitoring and controls, laboratory tests, medication, hygiene measures, drain care, mobilization and positioning, support and accompaniment of families and patients, administrative and management tasks), respiratory assistance, cardiovascular assistance, renal assistance, neurological assistance, metabolic assistance and specific interventions.

The final score is expressed as a percentage of nursing time., 16 months|Impact on nursing staff comfort according to the Nursing Activity Score., Compare the comfort of use of the device by nursing staff during the provision of care between the 2 groups The scale comprises 7 categories for a total of 23 items: basic activities (monitoring and controls, laboratory tests, medication, hygiene measures, drain care, mobilization and positioning, support and accompaniment of families and patients, administrative and management tasks), respiratory assistance, cardiovascular assistance, renal assistance, neurological assistance, metabolic assistance and specific interventions.

The final score is expressed as a percentage of nursing time., 16 months|Budgetary impact : comparison of the average total price per patient (consumables, labor), taking into account additional expenses in the event of medical complications related to the fixation system, Carry out a comparative budget impact analysis : The costs of each method of intubation tube fixation will be calculated per patient, in order to perform a medico-economic analysis. The following will be measured: the cost of consumables in each group, the cost of adverse events (PAVM, accidental extubation, etc.) and the cost of nursing time allocated to this management., 16 months