RecruitingNot ApplicableNCT06533436

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

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


Sponsor

Hopital Foch

Enrollment

250 participants

Start Date

Aug 2, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria5

  • 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 Criteria9

  • 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.

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Interventions

PROCEDURECorded 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.

DEVICETube 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.

OTHERCaregiver'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.


Locations(1)

Hôpital Foch

Suresnes, France

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NCT06533436


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