Intubation ComplicationFIXATUBNCT04819425
"Comparison of Two Methods of Securing Endotracheal Tubes in Intensive Care : Elastic Adhesive Strips vs Lace In A Protective Sheath."
A study testing Elastic Adhesive Strips and Lace in A Protective Sheath in people with Intubation Complication, run by Centre Hospitalier Departemental Vendee at 13 sites in France.
Trial summary
Every year, in France, nearly 100,000 patients hospitalized in intensive care more than 48 hours require invasive respiratory assistance via an endotracheal tube. Appropriate tube fixation is essential to ensure effective ventilation while minimizing potential complications such as accidental extubations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intubation Complication
- What is being tested?
- Elastic Adhesive Strips and Lace in A Protective Sheath
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 768 participants
- Where
- 13 sitesFrance
- Study dates
- 28 Jun 2021to 10 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 hospitalized in Intensive Care Unit
- Age over 18
- Intubation for estimated duration > 48h
- Patient treated with vasopressors
- Patient or relative who received the information and are not opposed to study participation or patient included under the emergency procedure in the absence of contactable family members.
Who cannot join
- Pre-existing face lesions at ICU admission along the path of the endotracheal tube fixing.
- Admitted patient already intubated upon transfer from another ICU
- Nasotracheal intubation
- Patient in isolation for suspected COVID or clinically proven COVID
- Admitted tracheotomized patient
- Pregnant, nursing, parturient woman
Show all 10Show fewer
- Lack of social security affiliation
- Moribund
- Incapable major (under guardianship, curatorship)
- Patient deprived of liberty by court order
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
France13 sites
Centre Hospitalier d'Angoulême
Angoulême
CH Victor Dupouy
Argenteuil
Centre Hopitalier La Rochelle
La Rochelle
Centre Hospitalier Le Mans
Le Mans
Groupe Hospitalier Bretagne Sud
Lorient
CHU Nantes Hôtel Dieu
Nantes
Centre Hospitalier Régional d'Orléans
Orléans
CHI Poissy - Saint-Germain-en-Laye
Poissy
CHU de Poitiers
Poitiers
Hôpital Nord Laennec
Saint-Herblain
CH Saint-Nazaire
Saint-Nazaire
CHU La Réunion GHSR
Saint-Pierre
CHU de Tours
Tours
About this study
Official title: "Comparison of Two Methods of Securing Endotracheal Tubes in Intensive Care : Elastic Adhesive Strips vs Lace In A Protective Sheath. A Randomized Multicenter, Cluster and Crossover Controlled Study. FIXATUB"
Every year, in France, nearly 100,000 patients hospitalized in intensive care more than 48 hours require invasive respiratory assistance via an endotracheal tube.
Appropriate tube fixation is essential to ensure effective ventilation while minimizing potential complications such as accidental extubations. However, the fixation system chosen may lead to peribuccal lesions such as bedsores, shearing or cutaneous-mucous tear. These lesions are painful for patients and often unsightly as scar may remain.
Read more
There are no formal recommendations for the use of any type of fixing system. Thus, systems used to secure the endotracheal tube vary from one ICU to another.
The objective of this study is to demonstrate that the fixing strategy by elastic adhesive tape reduces the risk of developing a peribuccal lesion during the time of the endotracheal tube's maintenance.
- Conditions
- Intubation Complication
- Being tested
- Elastic Adhesive Strips, Lace in A Protective Sheath
- Keywords
- Endotracheal Tube, Securement, Facial skin tear, Lip ulcer, Critical care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elastic Adhesive StripsDevice
Securement of Endotracheal tube with Elastic Adhesive Strips
Lace in A Protective SheathDevice
Securement of Endotracheal tube with Lace in A Protective Sheath
| Study group | Role | What they receive |
|---|---|---|
| Elastic Adhesive Strips | Experimental | Endotracheal tube fixed by elastic adhesive tape (Tensoplast type adhesive tape):
The adhesive tape will be attached to the patient's face (opposite side to the endotracheal tube) and then two turns around the endotracheal tube will be made. The rest of the adhesive tape will be attached to the other side of the face (side of the endotracheal tube).
The laminated tape will be kept on the adhesive tape until it passes over the neck in order to avoid adhering to the hair.
Finally, the end of the adhesive tape will be replaced on the part already attached to the patient.
It will be changed daily and after stain or examinations if necessary. Receives: Device: Elastic Adhesive Strips |
| Lace in A Protective Sheath | Active comparator | A loop is made with the lace then the endotracheal tube is passed through the loop. The loop is tightened by pulling each side on the remaining cords and a knot is made on one side of the fastener.
It will be changed daily and after stain or examinations if necessary. Receives: Device: Lace in A Protective Sheath |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peribuccal lesion
Appearance of at least one peribuccal lesion during the first 10 days of maintaining the endotracheal tube inserted orally.
Presence of peribuccal lesion will be validated on picture by an independent review committee.
The picture will be taken daily without the visible fixing system (blind maintained for the adjudication committee) from J0 to J10 at the site of the endotracheal tube.
Measured: up to 10 days after intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2021
- Study start28 Jun 2021
- Primary completion10 Aug 2023
- Study completion10 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Cluster and Crossover
- Masking
- None (open label)
- Enrolment
- 768 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Departemental Vendee
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vanessa ZINZONI, Principal investigator, CHD Vendée
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04819425
- Sponsor's protocol ID
- CHD032-20
- Acronym
- FIXATUB
- Status last verified
- Nov 2023
- First submitted
- 19 Mar 2021
- Last updated
- 22 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zinzoni V, Planche L, Le Potier S, Robin L, Le Parco C, Terrat P, Leroyer MH, Atger R, Dauvergne JE, Muller L, Fontaine L, Morand C, Dennemont P, Paillard O, Vastral S, Dardaine B, Le Guillou S, Maquigneau N, Martin S, Lacherade JC. Impact of two endotracheal tube fixation on the incidence of peri-oral lesions: Elastic adhesive strips versus cord in a protective sheath. Study protocol for a cluster cross-over randomized trial. PLoS One. 2024 Feb 8;19(2):e0297349. doi: 10.1371/journal.pone.0297349. eCollection 2024.
PubMed 38330026
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Comparison of Two Methods of Securing Endotracheal Tubes in Intensive Care : Elastic Adhesive Strips vs Lace In A Protective Sheath. A Randomized Multicenter, Cluster and Crossover Controlled Study. FIXATUB"
- ClinicalTrials.gov ID
- NCT04819425
- Acronym / sponsor ID
- FIXATUB / CHD032-20
- Conditions
- Intubation Complication
- Keywords
- Endotracheal Tube, Securement, Facial skin tear, Lip ulcer, Critical care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 768 participants (actual)
- Lead sponsor
- Centre Hospitalier Departemental VendeeUniversity, hospital or other
- Study start
- 28 Jun 2021 (actual)
- Primary completion
- 10 Aug 2023 (actual)
- Study completion
- 10 Aug 2023 (actual)
- First posted
- 29 Mar 2021 (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.
Every year, in France, nearly 100,000 patients hospitalized in intensive care more than 48 hours require invasive respiratory assistance via an endotracheal tube.
Appropriate tube fixation is essential to ensure effective ventilation while minimizing potential complications such as accidental extubations. However, the fixation system chosen may lead to peribuccal lesions such as bedsores, shearing or cutaneous-mucous tear. These lesions are painful for patients and often unsightly as scar may remain.
There are no formal recommendations for the use of any type of fixing system. Thus, systems used to secure the endotracheal tube vary from one ICU to another.
The objective of this study is to demonstrate that the fixing strategy by elastic adhesive tape reduces the risk of developing a peribuccal lesion during the time of the endotracheal tube's maintenance.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cluster and Crossover
| Arm | Type | Receives |
|---|---|---|
| Elastic Adhesive Strips | Experimental | Device: Elastic Adhesive StripsEndotracheal tube fixed by elastic adhesive tape (Tensoplast type adhesive tape): The adhesive tape will be attached to the patient's face (opposite side to the endotracheal tube) and then two turns around the endotracheal tube will be made. The rest of the adhesive tape will be attached to the other side of the face (side of the endotracheal tube). The laminated tape will be kept on the adhesive tape until it passes over the neck in order to avoid adhering to the hair. Finally, the end of the adhesive tape will be replaced on the part already attached to the patient. It will be changed daily and after stain or examinations if necessary. |
| Lace in A Protective Sheath | Active comparator | Device: Lace in A Protective SheathA loop is made with the lace then the endotracheal tube is passed through the loop. The loop is tightened by pulling each side on the remaining cords and a knot is made on one side of the fastener. It will be changed daily and after stain or examinations if necessary. |
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 hospitalized in Intensive Care Unit
- Age over 18
- Intubation for estimated duration > 48h
- Patient treated with vasopressors
- Patient or relative who received the information and are not opposed to study participation or patient included under the emergency procedure in the absence of contactable family members.
Key exclusion criteria (10 listed)
- Pre-existing face lesions at ICU admission along the path of the endotracheal tube fixing.
- Admitted patient already intubated upon transfer from another ICU
- Nasotracheal intubation
- Patient in isolation for suspected COVID or clinically proven COVID
- Admitted tracheotomized patient
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 |
|---|---|---|
| Elastic Adhesive StripsSecurement of Endotracheal tube with Elastic Adhesive Strips | Device | Elastic Adhesive Strips |
| Lace in A Protective SheathSecurement of Endotracheal tube with Lace in A Protective Sheath | Device | Lace in A Protective Sheath |
Primary outcome
Peribuccal lesion
Time frame: up to 10 days after intubation
Appearance of at least one peribuccal lesion during the first 10 days of maintaining the endotracheal tube inserted orally. Presence of peribuccal lesion will be validated on picture by an independent review committee. The picture will be taken daily without the visible fixing system (blind maintained for the adjudication committee) from J0 to J10 at the site of the endotracheal tube.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
- Derived from this study: PubMed 38330026Zinzoni V, Planche L, Le Potier S, Robin L, Le Parco C, Terrat P, Leroyer MH, Atger R, Dauvergne JE, Muller L, Fontaine L, Morand C, Dennemont P, Paillard O, Vastral S, Dardaine B, Le Guillou S, Maquigneau N, Martin S, Lacherade JC. Impact of two endotracheal tube fixation on the incidence of peri-oral lesions: Elastic adhesive strips versus cord in a protective sheath. Study protocol for a cluster cross-over randomized trial. PLoS One. 2024 Feb 8;19(2):e0297349. doi: 10.1371/journal.pone.0297349. eCollection 2024.
- Individual participant dataSharing planned: No
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The ED-AWARENESS-2 Trial
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RecruitingObservational study
Cardiovascular History and Hemodynamic Complications After Intubation in ICU
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Postoperative Pulmonary Complications After Use of Supraglottic Airway Devices and Neuromuscular Blockade
Postoperative Pulmonary Complications
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Establish Whether Hyperangulated Videolaryngoscopy (HAVL) Can be Used to Facilitate Tracheal Intubation Effectively and Safely in Unselected Adult Patients; Describe the Population in Whom HAVL Fails to Facilitate Tracheal Intubation Successfully, Identifying Any Contributory Characteristics.
Intubation Skill, Intubation Complications
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. This study is not recruiting at the moment.
Vanessa ZINZONI principal investigator
CHD Vendée
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Elastic Adhesive Strips and Lace in A Protective Sheath in people with Intubation Complication, run by Centre Hospitalier Departemental Vendee at 13 sites 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 10 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: finished, as of the sponsor's last update on 22 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peribuccal lesion (time frame: up to 10 days after intubation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04819425, which also lists 1 linked publication.
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 22 Nov 2023.