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NCT Number: NCT06533436

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

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.

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Key information

Conditions

Intubation Complication Eschar

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Foch

Suresnes, 92150, France

Location status: Recruiting

Location contact

Marisa LAGOA PINTA

CONTACT

00 33 1 46 25 19 46

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Corded tube care

Procedure

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.

Tube care attached by AnchorFast

Device

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.

Caregiver's evaluation on each tube fixation

Other

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.

Primary outcomes

  1. Comparison of induced pressure sores

    Time frame: 16 months

    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.

Secondary outcomes

  1. Patient safety regarding the stability of the intubation : number of repositionning

    Time frame: 16 months

    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.

  2. Patient safety regarding the risk of accidental extubation

    Time frame: 16 months

    Compare the number of accidental extubation between the 2 groups

  3. Patient safety regarding ventilator-associated pneumonia

    Time frame: 16 months

    Compare the rate of ventilator-associated pneumonia (VAP) between the 2 groups

  4. Patient safety regarding intubation-related complications

    Time frame: 16 months

    Evaluate the occurrence of intubation-related complications

  5. Impact on nursing staff care load

    Time frame: 16 months

    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.

  6. Impact on nursing staff comfort according to the Nursing Activity Score.

    Time frame: 16 months

    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.

  7. 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

    Time frame: 16 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Marisa LAGOA PINTO

CONTACT

[email protected]

00 33 1 46 25 36 35

Marjolaine NGOLLO, PhD

CONTACT

[email protected]

+33 146 25 37 49

Sponsors and collaborators

Lead sponsor

Hopital Foch

Other

Registry information

Official study 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

Acronym: AnchorDon

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Aug 1, 2024
Registry last updated
Jun 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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