Clinical trial NCT06533436: Clinical and Economic Comparison of 2 Methods of Intubation Tube Fixation : AnchorFastTM Versus Current Cord Fixation
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Intubation Complication
Eschar
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2024-08-01
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: A total of 170 patients will be included over two distinct 6-month periods (85 patients per period). Each period corresponds to the study of one fixation device: cord fixation or fixation with the AnchorFastTM medical device.

The caregivers will also be included as a population since the workload with the two types of device will be evaluated and compared.
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Comparison of induced pressure sores
timeFrame: 16 months
Secondary outcomes:
measure: Patient safety regarding the stability of the intubation : number of repositionning
timeFrame: 16 months
measure: Patient safety regarding the risk of accidental extubation
timeFrame: 16 months
measure: Patient safety regarding ventilator-associated pneumonia
timeFrame: 16 months
measure: Patient safety regarding intubation-related complications
timeFrame: 16 months
measure: Impact on nursing staff care load
timeFrame: 16 months
measure: Impact on nursing staff comfort according to the Nursing Activity Score.
timeFrame: 16 months
measure: 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
timeFrame: 16 months
Other outcomes:
Locations:
city: Suresnes
country: France
facility: Hôpital Foch
Study officials:
affiliation: Hôpital Foch
name: Marisa LAGOA PINTO
role: PRINCIPAL_INVESTIGATOR
References: