Intubation ComplicationAnchorDonNCT06533436
Clinical and Economic Comparison of 2 Methods of Intubation Tube Fixation : AnchorFastTM Versus Current Cord Fixation
A study testing Corded tube care, Tube care attached by AnchorFast and Caregiver's evaluation on each tube fixation in people with Intubation Complication and Eschar, run by Hopital Foch at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intubation Complication, Eschar
- What is being tested?
- Corded tube care, Tube care attached by AnchorFast and Caregiver's evaluation on each tube fixation
- Type of treatment
- Pill or oral medicine, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 1 siteFrance
- Study dates
- 2 Aug 2024to 1 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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,
Show all 9Show fewer
- Patient in ventral position,
- Pregnant or breast-feeding woman,
- Patient deprived of liberty or under guardianship.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpital Foch
Suresnes, 92150
Marisa LAGOA PINTA, 00 33 1 46 25 19 46
About this study
Official 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
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.
Read the 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.
- Conditions
- Intubation Complication, Eschar
- Being tested
- Corded tube care, Tube care attached by AnchorFast, Caregiver's evaluation on each tube fixation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Corded tube careProcedure or 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 AnchorFastDevice
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 fixationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Caregiver's evaluation on each tube fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 16 months
Secondary outcomes (7)
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.
Measured: 16 months
Patient safety regarding the risk of accidental extubation
Compare the number of accidental extubation between the 2 groups
Measured: 16 months
Patient safety regarding ventilator-associated pneumonia
Compare the rate of ventilator-associated pneumonia (VAP) between the 2 groups
Measured: 16 months
Patient safety regarding intubation-related complications
Evaluate the occurrence of intubation-related complications
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 16 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2024
- Study start2 Aug 2024
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intubation ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- A total of 190 patients will be included over two distinct periods (95 patients per period). Each period corresponds to the study of one fixation device: cord fixation or fixation with the AnchorFastTM medical device. Healthcare professionals will also be included in the study population, as the workload associated with these two types of devices will be assessed and compared.
- Masking
- None (open label)
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hopital Foch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marisa LAGOA PINTO, Principal investigator, Hôpital Foch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06533436
- Sponsor's protocol ID
- 2021_0208
- Other IDs
- 2023-A01371-44
- Acronym
- AnchorDon
- Status last verified
- Jun 2026
- First submitted
- 28 Feb 2024
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06533436
- Acronym / sponsor ID
- AnchorDon / 2021_0208
- Conditions
- Intubation Complication, Eschar
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Hopital FochUniversity, hospital or other
- Study start
- 2 Aug 2024 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 1 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- A total of 190 patients will be included over two distinct periods (95 patients per period). Each period corresponds to the study of one fixation device: cord fixation or fixation with the AnchorFastTM medical device. Healthcare professionals will also be included in the study population, as the workload associated with these two types of devices will be assessed and compared.
| Arm | Type | Receives |
|---|---|---|
| Cord attachement | Active comparator | Procedure: Corded tube careCaregivers 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. |
| AnchorFast | Experimental | Device: Tube care attached by AnchorFastThe 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. |
| Caregivers | Other | Other: Caregiver's evaluation on each tube fixationThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Corded tube careThe 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. | Procedure or surgery | Cord attachement |
| Tube care attached by AnchorFastShaving 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. | Device | AnchorFast |
| Caregiver's evaluation on each tube fixationThe 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. | Other | Caregivers |
Primary outcome
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.
7 secondary outcomes
Patient safety regarding the stability of the intubation : number of repositionning
Time frame: 16 months
Patient safety regarding the risk of accidental extubation
Time frame: 16 months
Patient safety regarding ventilator-associated pneumonia
Time frame: 16 months
Patient safety regarding intubation-related complications
Time frame: 16 months
Impact on nursing staff care load
Time frame: 16 months
Impact on nursing staff comfort according to the Nursing Activity Score.
Time frame: 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
Time frame: 16 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marisa LAGOA PINTO principal investigator
Hôpital Foch
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Corded tube care, Tube care attached by AnchorFast and Caregiver's evaluation on each tube fixation in people with Intubation Complication and Eschar, run by Hopital Foch at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marisa LAGOA PINTO (00 33 1 46 25 36 35, m.lagoa-pinto@hopital-foch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of induced pressure sores (time frame: 16 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.