NCT06533436 Clinical and Economic Comparison of 2 Methods of Intubation Tube Fixation : AnchorFastTM Versus Current Cord Fixation
| NCT ID | NCT06533436 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hopital Foch |
| Condition | Intubation Complication |
| Study Type | INTERVENTIONAL |
| Enrollment | 250 participants |
| Start Date | 2024-08-02 |
| Primary Completion | 2026-08-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 250 participants in total. It began in 2024-08-02 with a primary completion date of 2026-08-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Marisa LAGOA PINTO
PRINCIPAL INVESTIGATOR
Hôpital Foch
Frequently Asked Questions
Who can join the NCT06533436 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Intubation Complication. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06533436 currently recruiting?
Yes, NCT06533436 is actively recruiting participants. Contact the research team at m.lagoa-pinto@hopital-foch.com for enrollment information.
Where is the NCT06533436 trial being conducted?
This trial is being conducted at Suresnes, France.
Who is sponsoring the NCT06533436 clinical trial?
NCT06533436 is sponsored by Hopital Foch. The principal investigator is Marisa LAGOA PINTO at Hôpital Foch. The trial plans to enroll 250 participants.