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

Официальное название

Clinical and Economic Comparison of 2 Methods of Intubation Tube Fixation in the Intensive Care Unit: Benefits of Intubation Tube Fixation With AnchorFastTM Versus Current Cord Fixation

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура 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.
• Устройство 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.
• Другое 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 fixa

Первичные конечные точки

• Comparison of induced pressure sores [Срок оценки: 16 months]

Вторичные конечные точки (7)

• Patient safety regarding the stability of the intubation : number of repositionning [Срок оценки: 16 months]
• Patient safety regarding the risk of accidental extubation [Срок оценки: 16 months]
• Patient safety regarding ventilator-associated pneumonia [Срок оценки: 16 months]
• Patient safety regarding intubation-related complications [Срок оценки: 16 months]
• Impact on nursing staff care load [Срок оценки: 16 months]
• Impact on nursing staff comfort according to the Nursing Activity Score. [Срок оценки: 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 [Срок оценки: 16 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Франция · 1 центр

• Hôpital Foch — Suresnes

Идентификаторы

NCT: NCT06533436 · 2021_0208 · 2023-A01371-44

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗