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

NCT06533436 | Recruiting

• 2 other identifiers: 2021_02082023-A01371-44
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Intubation Complication; Eschar

Outcome Measures

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.

  16 months

Secondary Outcomes (7)

• Patient safety regarding the stability of the intubation : number of repositionning

  16 months

• Patient safety regarding the risk of accidental extubation

  16 months

• Patient safety regarding ventilator-associated pneumonia

  16 months

• Patient safety regarding intubation-related complications

  16 months

• Impact on nursing staff care load

  16 months

Study Arms (3)

Cord attachement

ACTIVE COMPARATOR

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

AnchorFast

EXPERIMENTAL

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

Caregivers

OTHER

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

Interventions

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.

Cord attachement

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.

AnchorFast

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.

Caregivers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hopital Foch: lead

Study Sites (1)

Hôpital Foch

Suresnes, 92150, France

RECRUITING

Study Officials

• Marisa LAGOA PINTO

  Hôpital Foch

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marisa LAGOA PINTO

CONTACT

00 33 1 46 25 36 35; m.lagoa-pinto@hopital-foch.com

Marjolaine NGOLLO, PhD

CONTACT

+33 146 25 37 49; drci-promotion@hopital-foch.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A total of 170 patients will be included over two distinct 6-month periods (85 patients per period). Each period corresponds to the study of one fixation device: cord fixation or fixation with the AnchorFastTM medical device. The caregivers will also be included as a population since the workload with the two types of device will be evaluated and compared.

Study Record Dates

• First Submitted: February 28, 2024
• First Posted: August 1, 2024
• Study Start: August 2, 2024
• Primary Completion (Estimated): August 2, 2026
• Study Completion (Estimated): December 2, 2026
• Last Updated: February 12, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)