ChlorhexidineNCT02583321

Detection of Chlorhexidine in Tracheal Secretions After Routine Oral Care With Chlorhexidine Gluconate

A study testing Endotracheal tubes not allowing SSD and Endotracheal tubes allowing SSD in people with Chlorhexidine and Intensive Care, run by Centre Hospitalier Departemental Vendee at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Chlorhexidine, Intensive Care
What is being tested?: Endotracheal tubes not allowing SSD and Endotracheal tubes allowing SSD
Type of treatment: Pill or oral medicine, Injection or infusion, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 66 participants
Where: 1 siteFrance
Study dates: 4 Nov 2015to 9 Jan 2017
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

Age over 18 years
Invasive mechanical ventilation (MV) delivered via an endotracheal tube and MV required more than 72 hours
Intubation performed in units in which the specific endotracheal tube allowing the subglottic secretions drainage (SSD) will be available during the SSD period of the trial
Information delivered

Who cannot join

Previous inclusion in the study
Patients moribund at the ICU admission
Pregnant, parturient or breast-feeding woman
Patient hospitalized without consent and/or deprived of liberty by court's decision
Patient under guardianship or curators
Lack of social insurance
Concomitant inclusion in a trial on VAP prevention
Patient with no comprehension of the French language

Trial locations and contacts

1 site in 1 country.

France1 site

CHD Vendee
La Roche-sur-Yon, 85170

Other trials in France

About this study

Official title: Detection of Chlorhexidine in Tracheal Secretions After Routine Oral Care With Chlorhexidine Gluconate: an Ancillary Study of the DEMETER Trial (NCT02515617)

Recent meta-analysis have suggested that the safety of oral care with chlorhexidine in patients under mechanical ventilation could be questionable. Whatever the hypothetical mechanisms involved (direct cellular toxicity, underdiagnosis of Ventilator-Associated Pneumonia), presence of chlorhexidine in tracheal secretions after routine oral care is the cornerstone of this potential side effect of the routine oral care with chlorhexidine gluconate. The DEMETER study assessing the medico-economical impact of the subglottic secretions drainage study (NCT02515617) provides the opportunity to perform this proof of concept study (detection of chlorhexidine in tracheal secretions after routine oral care with chlorhexidine gluconate) and to evaluate the impact of the subglottic secretion drainage on this potential detection of chlorhexidine.

This ancillary study will be performed in one of the centers participating to the DEMETER study.

Conditions: Chlorhexidine, Intensive Care
Being tested: Endotracheal tubes not allowing SSD, Endotracheal tubes allowing SSD
Keywords: chlorhexidine gluconate, oral care, mechanical ventilation, critically ill patients, tracheal secretions, subglottic secretions

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Endotracheal tubes not allowing SSDDevice
In the participating center, a bundle of Ventilator-Associated Pneumonia (VAP) prevention will be applied: elevate the head of the bed to 30°-45°, regular oral care, manage patients with sedation algorithm, assess readiness to extubate daily, intermittent control of endotracheal tube cuff pressure
Endotracheal tubes allowing SSDDevice
In the participating center, a bundle of VAP prevention will be applied: elevate the head of the bed to 30°-45°, regular oral care, manage patients with sedation algorithm, assess readiness to extubate daily, intermittent control of endotracheal tube cuff pressure.
In addition, SSD will be realized using a 10 ml syringe at in attending frequency of 2 hours.

Study groups in NCT02583321
Study group	Role	What they receive
Period with endotracheal tubes not allowing SSD	Active comparator	During this period of the DEMETER study (NCT02515617), patients will be intubated with standard endotracheal tubes not allowing Subglottic Secretions Receives: Device: Endotracheal tubes not allowing SSD
Period with endotracheal tubes allowing SSD	Experimental	During this period of the DEMETER study (NCT02515617), patients will be intubated with specific endotracheal tubes allowing Subglottic Secretions Drainage Receives: Device: Endotracheal tubes allowing SSD

What is being measured

The primary outcome is the main question the study is designed to answer.

Rate of patients with detection of chlorhexidine in tracheal secretions during the period without SSD
Measured: Day 3 of mechanical ventilation

Secondary outcomes (4)

Rate of patients with detection of chlorhexidine in tracheal secretions during the period with SSD
Measured: Day 3 of mechanical ventilation
Cumulative incidence of detection of chlorhexidine in tracheal secretions according to the study group.
Measured: Day 28 of mechanical ventilation
Rate of patients with detection of chlorhexidine in subglottic secretions during the period with SSD
Measured: Day 3 of mechanical ventilation
Cumulative incidence of detection of chlorhexidine in subglottic secretions during the SSD period.
Measured: Day 28 of mechanical ventilation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Nov 20159 Jan 2017

First posted22 Oct 2015 (estimated)
Study start4 Nov 2015
Primary completion5 Jan 2017
Study completion9 Jan 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for ChlorhexidineStudies 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: Prevention
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind
Who is masked: Care provider
Enrolment: 66 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02583321
Sponsor's protocol ID: CHD 054-15
Status last verified: Feb 2019
First submitted: 20 Oct 2015
Last updated: 26 Feb 2019
Results posted: No
Data monitoring committee: Yes

Publications

Klompas M, Speck K, Howell MD, Greene LR, Berenholtz SM. Reappraisal of routine oral care with chlorhexidine gluconate for patients receiving mechanical ventilation: systematic review and meta-analysis. JAMA Intern Med. 2014 May;174(5):751-61. doi: 10.1001/jamainternmed.2014.359.
PubMed 24663255
Price R, MacLennan G, Glen J; SuDDICU Collaboration. Selective digestive or oropharyngeal decontamination and topical oropharyngeal chlorhexidine for prevention of death in general intensive care: systematic review and network meta-analysis. BMJ. 2014 Mar 31;348:g2197. doi: 10.1136/bmj.g2197.
PubMed 24687313

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 26 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Detection of Chlorhexidine in Tracheal Secretions After Routine Oral Care With Chlorhexidine Gluconate: an Ancillary Study of the DEMETER Trial (NCT02515617)
ClinicalTrials.gov ID: NCT02583321
Acronym / sponsor ID: CHD 054-15
Conditions: Chlorhexidine, Intensive Care
Keywords: chlorhexidine gluconate, oral care, mechanical ventilation, critically ill patients, tracheal secretions, subglottic secretions
Study type: Interventional
Recruitment status: Completed
Enrolment: 66 participants (actual)
Lead sponsor: Centre Hospitalier Departemental VendeeUniversity, hospital or other
Collaborators: Ministry of Health, France, University Hospital, Angers
Study start: 4 Nov 2015 (actual)
Primary completion: 5 Jan 2017 (actual)
Study completion: 9 Jan 2017 (actual)
First posted: 22 Oct 2015 (estimated)
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.

This ancillary study will be performed in one of the centers participating to the DEMETER study.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (care provider)
Number of arms: 2

Arm	Type	Receives
Period with endotracheal tubes not allowing SSD	Active comparator	Device: Endotracheal tubes not allowing SSDDuring this period of the DEMETER study (NCT02515617), patients will be intubated with standard endotracheal tubes not allowing Subglottic Secretions
Period with endotracheal tubes allowing SSD	Experimental	Device: Endotracheal tubes allowing SSDDuring this period of the DEMETER study (NCT02515617), patients will be intubated with specific endotracheal tubes allowing Subglottic Secretions Drainage

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Age over 18 years
Invasive mechanical ventilation (MV) delivered via an endotracheal tube and MV required more than 72 hours
Intubation performed in units in which the specific endotracheal tube allowing the subglottic secretions drainage (SSD) will be available during the SSD period of the trial
Information delivered

Key exclusion criteria (8 listed)

Previous inclusion in the study
Patients moribund at the ICU admission
Pregnant, parturient or breast-feeding woman
Patient hospitalized without consent and/or deprived of liberty by court's decision
Patient under guardianship or curators

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
Endotracheal tubes not allowing SSDIn the participating center, a bundle of Ventilator-Associated Pneumonia (VAP) prevention will be applied: elevate the head of the bed to 30°-45°, regular oral care, manage patients with sedation algorithm, assess readiness to extubate daily, intermittent control of endotracheal tube cuff pressure	Device	Period with endotracheal tubes not allowing SSD
Endotracheal tubes allowing SSDIn the participating center, a bundle of VAP prevention will be applied: elevate the head of the bed to 30°-45°, regular oral care, manage patients with sedation algorithm, assess readiness to extubate daily, intermittent control of endotracheal tube cuff pressure. In addition, SSD will be realized using a 10 ml syringe at in attending frequency of 2 hours.	Device	Period with endotracheal tubes allowing SSD

Primary outcome

Rate of patients with detection of chlorhexidine in tracheal secretions during the period without SSD
Time frame: Day 3 of mechanical ventilation

4 secondary outcomes

Rate of patients with detection of chlorhexidine in tracheal secretions during the period with SSD
Time frame: Day 3 of mechanical ventilation
Cumulative incidence of detection of chlorhexidine in tracheal secretions according to the study group.
Time frame: Day 28 of mechanical ventilation
Rate of patients with detection of chlorhexidine in subglottic secretions during the period with SSD
Time frame: Day 3 of mechanical ventilation
Cumulative incidence of detection of chlorhexidine in subglottic secretions during the SSD period.
Time frame: Day 28 of mechanical ventilation

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 26 Feb 2019.
Background: PubMed 24663255Klompas M, Speck K, Howell MD, Greene LR, Berenholtz SM. Reappraisal of routine oral care with chlorhexidine gluconate for patients receiving mechanical ventilation: systematic review and meta-analysis. JAMA Intern Med. 2014 May;174(5):751-61. doi: 10.1001/jamainternmed.2014.359.
Background: PubMed 24687313Price R, MacLennan G, Glen J; SuDDICU Collaboration. Selective digestive or oropharyngeal decontamination and topical oropharyngeal chlorhexidine for prevention of death in general intensive care: systematic review and network meta-analysis. BMJ. 2014 Mar 31;348:g2197. doi: 10.1136/bmj.g2197.

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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. This study is not recruiting at the moment.

Jean-Claude LACHERADE, MD principal investigator

CHD VENDEE

Bertrand Diquet, Ph.D principal investigator

University Hospital, Angers

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 4 inclusion and 8 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 26 Feb 2019. 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?

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?

Rate of patients with detection of chlorhexidine in tracheal secretions during the period without SSD (time frame: Day 3 of mechanical ventilation). 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 NCT02583321, which also lists 2 linked publications.

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 26 Feb 2019.