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

ConditionsIntubation ComplicationEschar
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHopital Foch

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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,

Trial design

Design model

Sequential

Treatments tested in this trial

  • Corded tube care

    Procedure/Surgery

    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 intervention

    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.

Treatment groups

350 Participants
are divided into 3 treatment groups
Group A: Cord attachementActive comparator 1 intervention
Group B: AnchorFastExperimental treatment 1 intervention
Group C: CaregiversOther 1 intervention

Trial outcomes

Primary outcomes

1

Comparison 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

Secondary outcomes

1

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
2

Patient safety regarding the risk of accidental extubation

Compare the number of accidental extubation between the 2 groups

Time frame
16 months
3

Patient safety regarding ventilator-associated pneumonia

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

Time frame
16 months
4

Patient safety regarding intubation-related complications

Evaluate the occurrence of intubation-related complications

Time frame
16 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hopital Foch

Lead sponsor

Source ClinicalTrials.gov
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