Mechanical Ventilation ComplicationPhase 3ASPIRENCT01555229
Effect of Intermittent Versus Continuous Subglottic Secretion Drainage on Tracheal Mucosa Damages
A Phase 3 study testing Intermittent subglottic secretion drainage and Continuous subglottic secretion drainage in people with Mechanical Ventilation Complication, run by Rennes University Hospital at 1 site in France.
Trial summary
Endotracheal tubes with subglottic secretion drainage (incorporating a suction port above the cuff) have been shown to reduce the incidence of ventilator-associated pneumonia. Subglottic secretion drainage can be either continuous or intermittent. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mechanical Ventilation Complication
- What is being tested?
- Intermittent subglottic secretion drainage and Continuous subglottic secretion drainage
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- Aug 2011to Sep 2015
- Phase
- Phase 3
- 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
- Adult aged 18 years or more
- Patients hospitalized in intensive care unit
- Patients requiring endotracheal tube with an expected mechanical ventilation duration of more than 24 hours
Who cannot join
- Pregnant or breast-feeding women
- Previous known tracheal lesions
- Persons deprived of freedom
Trial locations and contacts
1 site in 1 country.
France1 site
Service de Réanimation Chirurgicale, Hôpital de Pontchaillou
Rennes, 35033
About this study
Official title: Randomized, Single Blind Study Comparing the Effect of Intermittent Versus Continuous Subglottic Secretion Drainage on Tracheal Mucosa Damages in Intensive Care Patients Requiring Prolonged Mechanical Ventilation
Endotracheal tubes with subglottic secretion drainage (incorporating a suction port above the cuff) have been shown to reduce the incidence of ventilator-associated pneumonia. Subglottic secretion drainage can be either continuous or intermittent. However, concerns about the safety of continuous subglottic secretion drainage were raised in an experimental study in sheep, which found widespread injuries to tracheal mucosa and/or submucosa. Our objective is therefore to compare intermittent versus continuous subglottic secretion drainage on tracheal mucosa damages in patients requiring mechanical ventilation for an expected duration of more than 24 hours.
Read the detailed description
Endotracheal tubes with subglottic secretion drainage (incorporating a suction port above the cuff) have been shown to reduce the incidence of ventilator-associated pneumonia. Subglottic secretion drainage can be either continuous or intermittent. However, concerns about the safety of continuous subglottic secretion drainage were raised in an experimental study in sheep, which found widespread injuries to tracheal mucosa and/or submucosa. Our objective is therefore to compare intermittent versus continuous subglottic secretion drainage on tracheal mucosa damages in patients requiring mechanical ventilation for an expected duration of more than 24 hours. Tracheal mucosa injuries will be assessed by tracheal fibroscopy. Secondary endpoints are the volume of daily secretions suctioned, the occurrence of difficulties or impossibilities of secretion drainage, and the occurrence of ventilator-associated pneumonia.
- Conditions
- Mechanical Ventilation Complication
- Being tested
- Intermittent subglottic secretion drainage, Continuous subglottic secretion drainage
- Keywords
- Secretion drainage, Ventilator-associated pneumonia, Tracheal fibroscopy
- Medical subject headings
- Pneumonia, Ventilator-Associated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent subglottic secretion drainageDevice
Subglottic secretion drainage is performed using a specially designed endotracheal tube with a separate dorsal lumen that opens immediately above the endotracheal cuff.
Continuous subglottic secretion drainageDevice
Subglottic secretion drainage is performed using a specially designed endotracheal tube with a separate dorsal lumen that opens immediately above the endotracheal cuff.
| Study group | Role | What they receive |
|---|---|---|
| Intermittent drainage | Experimental | Intermittent subglottic secretion drainage at -100 mmHg during 8 sec every 15 seconds. Receives: Device: Intermittent subglottic secretion drainage |
| Continuous drainage. | Active comparator | Continuous subglottic secretion drainage at -20 mmHg. Receives: Device: Continuous subglottic secretion drainage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tracheal mucosal damages assessed by tracheal fibroscopy.
- stage 0: no lesion
- stage 1: erythema
- stage 2 : oedema
- stage 3 : ulceration
- stage 4 : necrosis
Measured: the primary endpoint will be assessed just before extubation (variable duration depending on patient's status and cause of admission)
Secondary outcomes (3)
Volume of daily secretions
Measured: During intubation
Occurrence of difficulties or impossibilities of secretion drainage
Measured: During intubation
Occurrence of ventilator-associated pneumonia
Measured: During intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2012 (estimated)
- Study startAug 2011
- Primary completionSep 2015
- Study completionSep 2015
Why it stopped: Enrolment difficulties
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 Mechanical Ventilation ComplicationStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bruno Laviolle, MD, PhD, Study chair, Rennes University HospitalPhilippe Seguin, MD, PhD, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01555229
- Sponsor's protocol ID
- 2010-A00912-37
- Other IDs
- CIC0203/124, LOC/09-05
- Acronym
- ASPIRE
- Status last verified
- Apr 2015
- First submitted
- 1 Jul 2011
- Last updated
- 17 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Seguin P, Perrichet H, Pabic EL, Launey Y, Tiercin M, Corre R, Brinchault G, Laviolle B. Effect of Continuous versus Intermittent Subglottic Suctioning on Tracheal Mucosa by the Mallinckrodt TaperGuard Evac Oral Tracheal Tube in Intensive Care Unit Ventilated Patients: A Prospective Randomized Study. Indian J Crit Care Med. 2018 Jan;22(1):1-4. doi: 10.4103/ijccm.IJCCM_350_17.
PubMed 29422724
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Single Blind Study Comparing the Effect of Intermittent Versus Continuous Subglottic Secretion Drainage on Tracheal Mucosa Damages in Intensive Care Patients Requiring Prolonged Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT01555229
- Acronym / sponsor ID
- ASPIRE / 2010-A00912-37
- Conditions
- Mechanical Ventilation Complication
- Keywords
- Secretion drainage, Ventilator-associated pneumonia, Tracheal fibroscopy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enrolment difficulties
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 15 Mar 2012 (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.
Endotracheal tubes with subglottic secretion drainage (incorporating a suction port above the cuff) have been shown to reduce the incidence of ventilator-associated pneumonia. Subglottic secretion drainage can be either continuous or intermittent. However, concerns about the safety of continuous subglottic secretion drainage were raised in an experimental study in sheep, which found widespread injuries to tracheal mucosa and/or submucosa. Our objective is therefore to compare intermittent versus continuous subglottic secretion drainage on tracheal mucosa damages in patients requiring mechanical ventilation for an expected duration of more than 24 hours.
Detailed description
Endotracheal tubes with subglottic secretion drainage (incorporating a suction port above the cuff) have been shown to reduce the incidence of ventilator-associated pneumonia. Subglottic secretion drainage can be either continuous or intermittent. However, concerns about the safety of continuous subglottic secretion drainage were raised in an experimental study in sheep, which found widespread injuries to tracheal mucosa and/or submucosa. Our objective is therefore to compare intermittent versus continuous subglottic secretion drainage on tracheal mucosa damages in patients requiring mechanical ventilation for an expected duration of more than 24 hours. Tracheal mucosa injuries will be assessed by tracheal fibroscopy. Secondary endpoints are the volume of daily secretions suctioned, the occurrence of difficulties or impossibilities of secretion drainage, and the occurrence of ventilator-associated pneumonia.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intermittent drainage | Experimental | Device: Intermittent subglottic secretion drainageIntermittent subglottic secretion drainage at -100 mmHg during 8 sec every 15 seconds. |
| Continuous drainage. | Active comparator | Device: Continuous subglottic secretion drainageContinuous subglottic secretion drainage at -20 mmHg. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult aged 18 years or more
- Patients hospitalized in intensive care unit
- Patients requiring endotracheal tube with an expected mechanical ventilation duration of more than 24 hours
Key exclusion criteria (3 listed)
- Pregnant or breast-feeding women
- Previous known tracheal lesions
- Persons deprived of freedom
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 |
|---|---|---|
| Intermittent subglottic secretion drainageSubglottic secretion drainage is performed using a specially designed endotracheal tube with a separate dorsal lumen that opens immediately above the endotracheal cuff. | Device | Intermittent drainage |
| Continuous subglottic secretion drainageSubglottic secretion drainage is performed using a specially designed endotracheal tube with a separate dorsal lumen that opens immediately above the endotracheal cuff. | Device | Continuous drainage. |
Primary outcome
Tracheal mucosal damages assessed by tracheal fibroscopy.
Time frame: the primary endpoint will be assessed just before extubation (variable duration depending on patient's status and cause of admission)
* stage 0: no lesion * stage 1: erythema * stage 2 : oedema * stage 3 : ulceration * stage 4 : necrosis
3 secondary outcomes
Volume of daily secretions
Time frame: During intubation
Occurrence of difficulties or impossibilities of secretion drainage
Time frame: During intubation
Occurrence of ventilator-associated pneumonia
Time frame: During intubation
Results and safety
The study was stopped early (reason given: Enrolment difficulties). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2015.
- Derived from this study: PubMed 29422724Seguin P, Perrichet H, Pabic EL, Launey Y, Tiercin M, Corre R, Brinchault G, Laviolle B. Effect of Continuous versus Intermittent Subglottic Suctioning on Tracheal Mucosa by the Mallinckrodt TaperGuard Evac Oral Tracheal Tube in Intensive Care Unit Ventilated Patients: A Prospective Randomized Study. Indian J Crit Care Med. 2018 Jan;22(1):1-4. doi: 10.4103/ijccm.IJCCM_350_17.
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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.
Bruno Laviolle, MD, PhD study chair
Rennes University Hospital
Philippe Seguin, MD, PhD principal investigator
Rennes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Intermittent subglottic secretion drainage and Continuous subglottic secretion drainage in people with Mechanical Ventilation Complication, run by Rennes University Hospital 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 3 inclusion and 3 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: stopped early, as of the sponsor's last update on 17 Sep 2015. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Enrolment difficulties). Results are not available in the source record.
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?
Tracheal mucosal damages assessed by tracheal fibroscopy. (time frame: the primary endpoint will be assessed just before extubation (variable duration depending on patient's status and cause of admission)). 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 NCT01555229, 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 17 Sep 2015.