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.
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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
250
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.
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.
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.
Hôpital Foch
Suresnes, France
RECRUITINGComparison 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.
Time frame: 16 months
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.
Time frame: 16 months
Patient safety regarding the risk of accidental extubation
Compare the number of accidental extubation between the 2 groups
Time frame: 16 months
Patient safety regarding ventilator-associated pneumonia
Compare the rate of ventilator-associated pneumonia (VAP) between the 2 groups
Time frame: 16 months
Patient safety regarding intubation-related complications
Evaluate the occurrence of intubation-related complications
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 16 months
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