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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Intubation Complication; Eschar
• Intervention / Treatment: Procedure: Corded tube care; Device: Tube care attached by AnchorFast; Other: Caregiver's evaluation on each tube fixation

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.

• Study Type: Interventional
• Enrollment (Estimated): 250
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marisa LAGOA PINTO; Phone Number: 00 33 1 46 25 36 35; Email: m.lagoa-pinto@hopital-foch.com
• Study Contact Backup: Name: Marjolaine NGOLLO, PhD; Phone Number: +33 146 25 37 49; Email: drci-promotion@hopital-foch.com

Study Locations

• France
  • Suresnes, France, 92150
    • Recruiting
    • Hôpital Foch
    • Contact: Marisa LAGOA PINTA; Phone Number: 00 33 1 46 25 19 46

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Cord attachement; Caregivers follow the Tensoplast® white cord and elastic plaster fixation protocol, which has been revised and validated by the care department. Tube care is carried out in two stages: preparing the patient for the procedure (safety and hygiene) then renewal of the fixation device.	Procedure: Corded 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.
Experimental: AnchorFast; The AnchorFastTM fixation device developed by Laboratoire Hollister is a single-use medical device. This fixation system consists of a hard plastic guide on which the intubation tube can slide laterally. It facilitate access to the oral cavity and limit pressure points on the corners of the mouth.	Device: Tube 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.
Other: Caregivers; The caregivers will be included as a study population. Caregivers will conduct the search for the other two arms (ancofast and by cord) and then fill in questionnaires assessing the workload and comfort of tube care.	Other: Caregiver'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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	16 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	16 months
Patient safety regarding the risk of accidental extubation	Compare the number of accidental extubation between the 2 groups	16 months
Patient safety regarding ventilator-associated pneumonia	Compare the rate of ventilator-associated pneumonia (VAP) between the 2 groups	16 months
Patient safety regarding intubation-related complications	Evaluate the occurrence of intubation-related complications	16 months
Impact on nursing staff care load	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.	16 months
Impact on nursing staff comfort according to the Nursing Activity Score.	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.	16 months
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	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.	16 months

Collaborators and Investigators

• Sponsor: Hopital Foch
• Investigators: Principal Investigator: Marisa LAGOA PINTO, Hôpital Foch

Study record dates

Study Major Dates

• Study Start (Actual): August 2, 2024
• Primary Completion (Estimated): August 2, 2026
• Study Completion (Estimated): December 2, 2026

Study Registration Dates

• First Submitted: February 28, 2024
• First Submitted That Met QC Criteria: July 29, 2024
• First Posted (Actual): August 1, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 10, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 2021_0208; 2023-A01371-44 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No