Postoperative PneumoniaTETRISNCT01457248
Taper-shaped Cuff Endotracheal Tube Against Respiratory Infections
A study testing Endotracheal tube TaperGuard and Endotracheal tube Hi-Contour Brandt in people with Postoperative Pneumonia, run by Groupe Hospitalier Pitie-Salpetriere at 1 site in France.
Trial summary
The incidence of postoperative pneumonia after aortic surgery reaches 60%. In experimental lung model, endotracheal tube with taper-shaped cuff has been shown to decrease microaspiration. This effect has never been demonstrated in patients. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Postoperative Pneumonia
- What is being tested?
- Endotracheal tube TaperGuard and Endotracheal tube Hi-Contour Brandt
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2011to Jun 2014
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age ≥ 18 ans
- Elective aortic surgery
- Admission in ICU after aortic surgery
Who cannot join
- Tracheostomized patients
Trial locations and contacts
1 site in 1 country.
France1 site
Réanimation polyvalente, Département d'Anesthésie-Réanimation, Groupe Hospitalier Pitié-Salpêtrière
Paris, 75013
About this study
Official title: Effect of Endotracheal Tube With Taper-shaped Cuff on Incidence of Postoperative Pneumonia After Aortic Surgery
The incidence of postoperative pneumonia after aortic surgery reaches 60%. In experimental lung model, endotracheal tube with taper-shaped cuff has been shown to decrease microaspiration. This effect has never been demonstrated in patients. The investigators hypothesize that use of endotracheal tube with taper-shaped cuff decreases the incidence of postoperative pneumonia in patients after aortic surgery.
- Conditions
- Postoperative Pneumonia
- Being tested
- Endotracheal tube TaperGuard, Endotracheal tube Hi-Contour Brandt
- Keywords
- after aortic surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endotracheal tube TaperGuardDevice
Patients are intubated by endotracheal tube with taper-shaped cuff (TaperGuard, Mallinckrodt)
Endotracheal tube Hi-Contour BrandtDevice
Patients are intubated by endotracheal tube with cylindrical-shaped cuff (Hi-Contour Brandt, Mallinckrodt)
| Study group | Role | What they receive |
|---|---|---|
| endotracheal tube with taper-shaped cuff | Experimental | Not described Receives: Device: Endotracheal tube TaperGuard |
| Endotracheal tube with cylindrical-shaped cuff | Active comparator | Not described Receives: Device: Endotracheal tube Hi-Contour Brandt |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of first episode of postoperative pneumonia after aortic surgery
Measured: Within the first 28 days after surgery
Secondary outcomes (3)
Microaspiration
Measured: Day 1 and day 2
Length of ICU stay
Measured: Participants will be followed for the duration of ICU stay, an expected average of 3 weeks
Mortality
Measured: Day 28 and day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2011 (estimated)
- Study startOct 2011
- Primary completionJan 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Postoperative PneumoniaStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Groupe Hospitalier Pitie-Salpetriere
- Sponsor type
- University, hospital or other
- Collaborators
- Association pour la Recherche et la Formation en Anesthésie Analgésie Réanimation
- Responsible party
- Principal investigator, Qin Lu, Groupe Hospitalier Pitie-Salpetriere
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01457248
- Sponsor's protocol ID
- HMGS-2011-1
- Other IDs
- 2011-A01038-33
- Acronym
- TETRIS
- Status last verified
- Jul 2014
- First submitted
- 18 Oct 2011
- Last updated
- 3 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lucangelo U, Zin WA, Antonaglia V, Petrucci L, Viviani M, Buscema G, Borelli M, Berlot G. Effect of positive expiratory pressure and type of tracheal cuff on the incidence of aspiration in mechanically ventilated patients in an intensive care unit. Crit Care Med. 2008 Feb;36(2):409-13. doi: 10.1097/01.CCM.0000297888.82492.31.
PubMed 18007268Nseir S, Zerimech F, Fournier C, Lubret R, Ramon P, Durocher A, Balduyck M. Continuous control of tracheal cuff pressure and microaspiration of gastric contents in critically ill patients. Am J Respir Crit Care Med. 2011 Nov 1;184(9):1041-7. doi: 10.1164/rccm.201104-0630OC.
PubMed 21836137Dave MH, Frotzler A, Spielmann N, Madjdpour C, Weiss M. Effect of tracheal tube cuff shape on fluid leakage across the cuff: an in vitro study. Br J Anaesth. 2010 Oct;105(4):538-43. doi: 10.1093/bja/aeq202. Epub 2010 Aug 3.
PubMed 20682571Hortal J, Giannella M, Perez MJ, Barrio JM, Desco M, Bouza E, Munoz P. Incidence and risk factors for ventilator-associated pneumonia after major heart surgery. Intensive Care Med. 2009 Sep;35(9):1518-25. doi: 10.1007/s00134-009-1523-3. Epub 2009 Jun 26.
PubMed 19557389
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Endotracheal Tube With Taper-shaped Cuff on Incidence of Postoperative Pneumonia After Aortic Surgery
- ClinicalTrials.gov ID
- NCT01457248
- Acronym / sponsor ID
- TETRIS / HMGS-2011-1
- Conditions
- Postoperative Pneumonia
- Keywords
- after aortic surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- Groupe Hospitalier Pitie-SalpetriereUniversity, hospital or other
- Collaborators
- Association pour la Recherche et la Formation en Anesthésie Analgésie Réanimation
- Study start
- Oct 2011
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 21 Oct 2011 (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.
The incidence of postoperative pneumonia after aortic surgery reaches 60%. In experimental lung model, endotracheal tube with taper-shaped cuff has been shown to decrease microaspiration. This effect has never been demonstrated in patients. The investigators hypothesize that use of endotracheal tube with taper-shaped cuff decreases the incidence of postoperative pneumonia in patients after aortic surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| endotracheal tube with taper-shaped cuff | Experimental | Device: Endotracheal tube TaperGuard |
| Endotracheal tube with cylindrical-shaped cuff | Active comparator | Device: Endotracheal tube Hi-Contour Brandt |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 ans
- Elective aortic surgery
- Admission in ICU after aortic surgery
Key exclusion criteria (1 listed)
- Tracheostomized patients
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 tube TaperGuardPatients are intubated by endotracheal tube with taper-shaped cuff (TaperGuard, Mallinckrodt) | Device | endotracheal tube with taper-shaped cuff |
| Endotracheal tube Hi-Contour BrandtPatients are intubated by endotracheal tube with cylindrical-shaped cuff (Hi-Contour Brandt, Mallinckrodt) | Device | Endotracheal tube with cylindrical-shaped cuff |
Primary outcome
Incidence of first episode of postoperative pneumonia after aortic surgery
Time frame: Within the first 28 days after surgery
3 secondary outcomes
Microaspiration
Time frame: Day 1 and day 2
Length of ICU stay
Time frame: Participants will be followed for the duration of ICU stay, an expected average of 3 weeks
Mortality
Time frame: Day 28 and day 90
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 3 Jul 2014.
- Background: PubMed 18007268Lucangelo U, Zin WA, Antonaglia V, Petrucci L, Viviani M, Buscema G, Borelli M, Berlot G. Effect of positive expiratory pressure and type of tracheal cuff on the incidence of aspiration in mechanically ventilated patients in an intensive care unit. Crit Care Med. 2008 Feb;36(2):409-13. doi: 10.1097/01.CCM.0000297888.82492.31.
- Background: PubMed 21836137Nseir S, Zerimech F, Fournier C, Lubret R, Ramon P, Durocher A, Balduyck M. Continuous control of tracheal cuff pressure and microaspiration of gastric contents in critically ill patients. Am J Respir Crit Care Med. 2011 Nov 1;184(9):1041-7. doi: 10.1164/rccm.201104-0630OC.
- Background: PubMed 20682571Dave MH, Frotzler A, Spielmann N, Madjdpour C, Weiss M. Effect of tracheal tube cuff shape on fluid leakage across the cuff: an in vitro study. Br J Anaesth. 2010 Oct;105(4):538-43. doi: 10.1093/bja/aeq202. Epub 2010 Aug 3.
- Background: PubMed 19557389Hortal J, Giannella M, Perez MJ, Barrio JM, Desco M, Bouza E, Munoz P. Incidence and risk factors for ventilator-associated pneumonia after major heart surgery. Intensive Care Med. 2009 Sep;35(9):1518-25. doi: 10.1007/s00134-009-1523-3. Epub 2009 Jun 26.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endotracheal tube TaperGuard and Endotracheal tube Hi-Contour Brandt in people with Postoperative Pneumonia, run by Groupe Hospitalier Pitie-Salpetriere 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 1 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 3 Jul 2014. 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?
Incidence of first episode of postoperative pneumonia after aortic surgery (time frame: Within the first 28 days after surgery). 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 NCT01457248, which also lists 4 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 3 Jul 2014.