Clinical and Economic Comparison of 2 Methods of Intubation Tube Fixation : AnchorFastTM Versus Current Cord Fixation

Not Applicable

Not yet recruiting

• Conditions: Eschar; Intubation Complication
• Interventions: Procedure: Corded tube care; Device: Tube care attached by AnchorFast; Other: Caregiver's evaluation on each tube fixation

• Registration Number: NCT06533436
• Lead Sponsor: Hopital Foch

Brief 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.

Detailed Description

In 2022 at Hôpital FOCH, 41% of patients admitted to the intensive care unit required an orotracheal intubation tube (OIT), exposing them to the risk of developing orotracheal intubation tube (OIT), exposing them to the risk of developing ventilator-associated pneumonia (VAP).

Preventing VAP involves oral hygiene and limiting tube movements, which depend on the device used to attach the OIT . The care protocol used routinely in the department uses adhesive tape and a rigid cotton haberdashery cord. This type of fixation impedes buccal access, prevents easy repositioning of the probe and is liable to cause eschar lesions.

With the aim of improving the practices, the investigators took a closer look at the French recommendations. The Société de Réanimation de Langue Française (French Intensive Care Society) does not recommend a particular fixation method, but it does relay publications that shows the superiority of the AnchorfastTM device over adhesive tape fixation in terms of the incidence of pressure sores and accidental catheter mobilization.

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.

Study Timeline

• Study First Submitted: 2024-02-28
• Status Verified: 2024-07
• Study Start: 2024-07
• Study First Submitted QC: 2024-07-29
• Last Update Submitted: 2024-07-29
• Study First Posted: 2024-08-01
• Last Update Posted: 2024-08-01
• Primary Completion: 2025-05
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

• Patient over 18 years old,
• Patient with orotracheal intubation,
• Patient intubated no more than 24 hours previously,
• Oral consent from patient, trusted support person or relative if unable to consent
• Membership of a French health insurance scheme.

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Exclusion Criteria

• Pre-existing facial, labial or auricular skin lesions,
• Pre-existing mucositis,
• Patients extubated for more than 24 hours whose condition requires a new intubation tube
• Nasotracheal intubation,
• Planned early tracheotomy,
• Patient with occipital craniectomy,
• Patient in ventral position,
• Pregnant or breast-feeding woman,
• Patient deprived of liberty or under guardianship.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Cord attachement	Corded tube care	Caregivers follow the Tensoplast® white cord and elastic plaster fixation protocol, which has been revised and validated by the care department. Tube care is carried out in two stages: preparing the patient for the procedure (safety and hygiene) then renewal of the fixation device.
AnchorFast	Tube care attached by AnchorFast	The AnchorFastTM fixation device developed by Laboratoire Hollister is a single-use medical device. This fixation system consists of a hard plastic guide on which the intubation tube can slide laterally. It facilitate access to the oral cavity and limit pressure points on the corners of the mouth.
Caregivers	Caregiver's evaluation on each tube fixation	The caregivers will be included as a study population. Caregivers will conduct the search for the other two arms (ancofast and by cord) and then fill in questionnaires assessing the workload and comfort of tube care.

Primary Outcome Measures

Name	Time	Method
Comparison of induced pressure sores	16 months	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.

Secondary Outcome Measures

Name	Time	Method
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	16 months	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.
Patient safety regarding the stability of the intubation : number of repositionning	16 months	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.
Patient safety regarding the risk of accidental extubation	16 months	Compare the number of accidental extubation between the 2 groups
Impact on nursing staff care load	16 months	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.
Impact on nursing staff comfort according to the Nursing Activity Score.	16 months	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.
Patient safety regarding ventilator-associated pneumonia	16 months	Compare the rate of ventilator-associated pneumonia (VAP) between the 2 groups
Patient safety regarding intubation-related complications	16 months	Evaluate the occurrence of intubation-related complications

Trial Locations

Locations (1)

Hôpital Foch; 🇫🇷 Suresnes, France