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

Hopital Foch

Status: Enrolling

Conditions: Eschar; Intubation Complication

Treatments: Other: Caregiver's evaluation on each tube fixation; Device: Tube care attached by AnchorFast; Procedure: Corded tube care

Study type: Interventional

Funder types: Other

Identifiers

NCT06533436

2023-A01371-44 (Other Identifier)

2021_0208

Details and patient eligibility

About

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.

Full 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.

Enrollment: 250 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

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.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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250 participants in 3 patient groups

Cord attachement

Active Comparator group

Description:

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.

Treatment:

Procedure: Corded tube care

AnchorFast

Experimental group

Description:

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.

Treatment:

Device: Tube care attached by AnchorFast

Caregivers

Other group

Description:

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.

Treatment:

Other: Caregiver's evaluation on each tube fixation