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

Last updated: February 10, 2025
Sponsor: Hopital Foch
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Caregiver's evaluation on each tube fixation

Tube care attached by AnchorFast

Corded tube care

Clinical Study ID

NCT06533436
2021_0208
2023-A01371-44
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

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

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 intubationtube

  • 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.

Study Design

Total Participants: 250
Treatment Group(s): 3
Primary Treatment: Caregiver's evaluation on each tube fixation
Phase:
Study Start date:
August 02, 2024
Estimated Completion Date:
December 02, 2026

Study 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.

Connect with a study center

  • Hôpital Foch

    Suresnes, 92150
    France

    Active - Recruiting

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