Clinical and Economic Comparison of 2 Methods of Intubation Tube Fixation : AnchorFastTM Versus Current Cord Fixation
NCT ID: NCT06533436
Last Updated: 2025-02-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
250 participants
INTERVENTIONAL
2024-08-02
2026-12-02
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
The caregivers will also be included as a population since the workload with the two types of device will be evaluated and compared.
OTHER
NONE
Study Groups
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Cord attachement
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.
Corded tube care
The caregiver cut a 6 cm strip of Tensoplast® and wrapped it around the intubation probe at the level of the prescribed fixation mark at the corner of the mouth. The cord strands are placed around the patient's head, tightened, and a double knot is tied at the patient's cheek. Compresses are placed over the ears to protect them from possible lesions caused by the cords.
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.
Tube care attached by AnchorFast
Shaving is recommended for patients with beards, and prior family consent is required for patients with beards.
AnchorFast is Suitable for intubation probes from 5 to 10 mm in diameter, it adapts to different morphologies thanks to hydrocolloid dressings bonded to the face and an adjustable cord around the neck. Due to its rigidity, this device is not recommended for patients whose condition requires them to be positioned in the ventral decubitus (VD) or lateral decubitus position.
Caregivers
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.
Caregiver's evaluation on each tube fixation
The caregivers who performs the interventions according to the study will fill question form to assess the worload and the confort of the tube care for each intervention type The caregivers are both a research actor and a study population. One of the secondary aims of this study is to evaluate the two types of tube-fixing with regard to caregiver workload and comfort in performing care. Caregivers will complete identical questionnaires assessing their satisfaction with the two types of tube fixation studied in arms 1 and 2.
Interventions
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Corded tube care
The caregiver cut a 6 cm strip of Tensoplast® and wrapped it around the intubation probe at the level of the prescribed fixation mark at the corner of the mouth. The cord strands are placed around the patient's head, tightened, and a double knot is tied at the patient's cheek. Compresses are placed over the ears to protect them from possible lesions caused by the cords.
Tube care attached by AnchorFast
Shaving is recommended for patients with beards, and prior family consent is required for patients with beards.
AnchorFast is Suitable for intubation probes from 5 to 10 mm in diameter, it adapts to different morphologies thanks to hydrocolloid dressings bonded to the face and an adjustable cord around the neck. Due to its rigidity, this device is not recommended for patients whose condition requires them to be positioned in the ventral decubitus (VD) or lateral decubitus position.
Caregiver's evaluation on each tube fixation
The caregivers who performs the interventions according to the study will fill question form to assess the worload and the confort of the tube care for each intervention type The caregivers are both a research actor and a study population. One of the secondary aims of this study is to evaluate the two types of tube-fixing with regard to caregiver workload and comfort in performing care. Caregivers will complete identical questionnaires assessing their satisfaction with the two types of tube fixation studied in arms 1 and 2.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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Hopital Foch
OTHER
Responsible Party
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Principal Investigators
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Marisa LAGOA PINTO
Role: PRINCIPAL_INVESTIGATOR
Hôpital Foch
Locations
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Hôpital Foch
Suresnes, , France
Countries
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Central Contacts
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Facility Contacts
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Marisa LAGOA PINTA
Role: primary
Other Identifiers
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2023-A01371-44
Identifier Type: OTHER
Identifier Source: secondary_id
2021_0208
Identifier Type: -
Identifier Source: org_study_id
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