Mechanical VentilationExtu-CoughNCT01564745
Cough Determinants in Mechanically Ventilated Patients
A study testing Functional respiratory evaluation in people with Mechanical Ventilation, run by University Hospital, Caen at 2 sites in France.
Trial summary
In our knowledge there is only few data about the cough determinants in mechanically ventilated patients. However some failure of extubation is due to inefficiency cough. In order to determine some determinants of cough, the investigators propose to evaluate systematically different physiological parameters before and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mechanical Ventilation
- What is being tested?
- Functional respiratory evaluation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 2 sitesFrance
- Study dates
- Mar 2012to Dec 2015
- 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
- Patients mechanically ventilated since 72h
- Age > 18 years
- Hospitalized in Intensive care Unit
- In weaning phase - with the classically criteria to be extubated
- Patients who passed the weaning test (T tube test or other)
Who cannot join
- Hemodynamic instability
- Absence of consent
- No cooperation of the patient
- Hemodynamic instability
- pH < 7,30
- Severe hypoxemia
Trial locations and contacts
2 sites in 1 country.
France2 sites
University Hospital, Caen
Caen, 1400
University Hospital, Garches
Garches, 92380
About this study
Official title: Cough Determinants in Mechanically Ventilated Patients: a Physiological Study
In our knowledge there is only few data about the cough determinants in mechanically ventilated patients. However some failure of extubation is due to inefficiency cough. In order to determine some determinants of cough, the investigators propose to evaluate systematically different physiological parameters before and after extubation.
Read the detailed description
In order to evaluate, and identify the cough determinants, the investigators propose a physiological evaluation for each patients who were intubated and mechanically ventilated during at least 72 hours. Indeed inefficacy of cough after extubation is one of the main reason of extubation failure. However there is no any mean to evaluate it simply now.
- Conditions
- Mechanical Ventilation
- Being tested
- Functional respiratory evaluation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional respiratory evaluationOther
Also called Pulmonary Function test
Each enrolled patients has a pulmonary function test before and after extubation, and repeatedly at D1, D3, D5 (if they are always hospitalized)
| Study group | Role | What they receive |
|---|---|---|
| Cough Determinants | Other | Not described Receives: Other: Functional respiratory evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interest of systematically cough evaluation before extubation
All the patients enrolled have a physiological evaluation before and after extubation. After extubation the evaluation will be done respectively at D0, D1, D3 and D5. The first endpoint is the success of extubation which is evaluated à D2.
Measured: 2 days after extubation
Secondary outcomes (1)
Correlation between success of extubation and respiratory parameters
Measured: 2 days after extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionDec 2015
- Study completionDec 2015
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 VentilationStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe 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 N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France, Centre d'Investigation Clinique et Technologique 805
- Responsible party
- Sponsor
- Investigators
- Nicolas TERZI, MD - PhD, Principal investigator, University Hospital, CaenFrédéric Lofaso, MD-PhD, Principal investigator, University Hospital, GarchesDavid Orlikowski, MD-PhD, Principal investigator, University Hospital, Garches
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01564745
- Sponsor's protocol ID
- Extu-Cough
- Acronym
- Extu-Cough
- Status last verified
- Feb 2014
- First submitted
- 25 Mar 2012
- Last updated
- 22 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Terzi N, Lofaso F, Masson R, Beuret P, Normand H, Dumanowski E, Falaize L, Sauneuf B, Daubin C, Brunet J, Annane D, Parienti JJ, Orlikowski D. Physiological predictors of respiratory and cough assistance needs after extubation. Ann Intensive Care. 2018 Feb 5;8(1):18. doi: 10.1186/s13613-018-0360-3.
PubMed 29404723
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cough Determinants in Mechanically Ventilated Patients: a Physiological Study
- ClinicalTrials.gov ID
- NCT01564745
- Acronym / sponsor ID
- Extu-Cough / Extu-Cough
- Conditions
- Mechanical Ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France, Centre d'Investigation Clinique et Technologique 805
- Study start
- Mar 2012 (actual)
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 28 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.
In our knowledge there is only few data about the cough determinants in mechanically ventilated patients. However some failure of extubation is due to inefficiency cough. In order to determine some determinants of cough, the investigators propose to evaluate systematically different physiological parameters before and after extubation.
Detailed description
In order to evaluate, and identify the cough determinants, the investigators propose a physiological evaluation for each patients who were intubated and mechanically ventilated during at least 72 hours. Indeed inefficacy of cough after extubation is one of the main reason of extubation failure. However there is no any mean to evaluate it simply now.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cough Determinants | Other | Other: Functional respiratory evaluation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients mechanically ventilated since 72h
- Age > 18 years
- Hospitalized in Intensive care Unit
- In weaning phase - with the classically criteria to be extubated
- Patients who passed the weaning test (T tube test or other)
Key exclusion criteria (6 listed)
- Hemodynamic instability
- Absence of consent
- No cooperation of the patient
- Hemodynamic instability
- pH < 7,30
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 |
|---|---|---|
| Functional respiratory evaluationAlso: Pulmonary Function testEach enrolled patients has a pulmonary function test before and after extubation, and repeatedly at D1, D3, D5 (if they are always hospitalized) | Other | Cough Determinants |
Primary outcome
Interest of systematically cough evaluation before extubation
Time frame: 2 days after extubation
All the patients enrolled have a physiological evaluation before and after extubation. After extubation the evaluation will be done respectively at D0, D1, D3 and D5. The first endpoint is the success of extubation which is evaluated à D2.
1 secondary outcome
Correlation between success of extubation and respiratory parameters
Time frame: 2 days after extubation
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 Apr 2019.
- Derived from this study: PubMed 29404723Terzi N, Lofaso F, Masson R, Beuret P, Normand H, Dumanowski E, Falaize L, Sauneuf B, Daubin C, Brunet J, Annane D, Parienti JJ, Orlikowski D. Physiological predictors of respiratory and cough assistance needs after extubation. Ann Intensive Care. 2018 Feb 5;8(1):18. doi: 10.1186/s13613-018-0360-3.
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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.
Nicolas TERZI, MD - PhD principal investigator
University Hospital, Caen
Frédéric Lofaso, MD-PhD principal investigator
University Hospital, Garches
David Orlikowski, MD-PhD principal investigator
University Hospital, Garches
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional respiratory evaluation in people with Mechanical Ventilation, run by University Hospital, Caen at 2 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 6 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 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Interest of systematically cough evaluation before extubation (time frame: 2 days after extubation). 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 NCT01564745, 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 Apr 2019.