Thoracic SurgeryARCTICSNCT02804997
Evaluation of the Alveolar Recruitment Obtained During Non-invasive Ventilation After Cardiac Surgery
An observational study of Thoracic Surgery, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
The great majority of cardiac surgery patients develop a degree of post-operatory respiratory failure. This is due to several factors. The predominant element in the onset of this respiratory impairment is the constitution of foci of pulmonary atelectasis, caused by peroperative hypoventilation (in the presence or… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thoracic Surgery
- How many people
- 17 participants
- Where
- 1 siteFrance
- Study dates
- 13 May 2015to 27 Jan 2017
- Phase
- Observational
- 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
Study population: patients in the post-operative phase after elective cardiac surgery for aortic or mitral valve replacement, coronary revascularization or mixed surgery, hypoxemia or hypercapnia, with an indication for NIV, hemodynamic stability, prior consent, spontaneous ventilation, social security coverage
Who may be able to join
- Age ≥18
- in the post-operative phase after elective cardiac surgery for aortic or mitral valve replacement, coronary revascularization or mixed surgery, hypoxemia or hypercapnia, with an indication for NIV,
- hemodynamic stability
- prior consent
- spontaneous ventilation
- social security coverage.
Who cannot join
- Under-18 patients
- complex cardiac surgery
- pregnancy
- pre-existing chronic obstructive respiratory disease (COPD > stage II)
- legal guardianship
- incarceration
Trial locations and contacts
1 site in 1 country.
About this study
The great majority of cardiac surgery patients develop a degree of post-operatory respiratory failure. This is due to several factors. The predominant element in the onset of this respiratory impairment is the constitution of foci of pulmonary atelectasis, caused by peroperative hypoventilation (in the presence or absence of ECC). The incidence has been evaluated at between 54% and 92%, depending on the study. The use of NIV (non-invasive ventilation) might (through the application of continuous positive expiratory pressure) help to counter the development of these atelectasic foci.
- Conditions
- Thoracic Surgery
- Keywords
- non-invasive ventilation, cardiac surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantitative evaluation by thoracic CT scan
Quantitative evaluation performed by thoracic CT scan of alveolar recruitment induced by NIV after cardiac surgery
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2016 (estimated)
- Study start13 May 2015
- Primary completion27 Jan 2017
- Study completion27 Jan 2017
Why it stopped: internal recruitment difficulties and reorganization of the Intensive Care Units
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracic SurgeryStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elie ZOGHEIB, PhD, Principal investigator, CHU Amiens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02804997
- Sponsor's protocol ID
- PI2014_843_0020
- Acronym
- ARCTICS
- Status last verified
- Sep 2018
- First submitted
- 15 Jun 2016
- Last updated
- 1 Oct 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Alveolar Recruitment Obtained During Non-invasive Ventilation After Cardiac Surgery
- ClinicalTrials.gov ID
- NCT02804997
- Acronym / sponsor ID
- ARCTICS / PI2014_843_0020
- Conditions
- Thoracic Surgery
- Keywords
- non-invasive ventilation, cardiac surgery
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: internal recruitment difficulties and reorganization of the Intensive Care Units
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 13 May 2015 (actual)
- Primary completion
- 27 Jan 2017 (actual)
- Study completion
- 27 Jan 2017 (actual)
- First posted
- 17 Jun 2016 (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 great majority of cardiac surgery patients develop a degree of post-operatory respiratory failure. This is due to several factors. The predominant element in the onset of this respiratory impairment is the constitution of foci of pulmonary atelectasis, caused by peroperative hypoventilation (in the presence or absence of ECC). The incidence has been evaluated at between 54% and 92%, depending on the study. The use of NIV (non-invasive ventilation) might (through the application of continuous positive expiratory pressure) help to counter the development of these atelectasic foci.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients in the post-operative phase after elective cardiac surgery for aortic or mitral valve replacement, coronary revascularization or mixed surgery, hypoxemia or hypercapnia, with an indication for NIV, hemodynamic stability, prior consent, spontaneous ventilation, social security coverage
Key inclusion criteria (6 listed)
- Age ≥18
- in the post-operative phase after elective cardiac surgery for aortic or mitral valve replacement, coronary revascularization or mixed surgery, hypoxemia or hypercapnia, with an indication for NIV,
- hemodynamic stability
- prior consent
- spontaneous ventilation
Key exclusion criteria (6 listed)
- Under-18 patients
- complex cardiac surgery
- pregnancy
- pre-existing chronic obstructive respiratory disease (COPD > stage II)
- legal guardianship
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Quantitative evaluation by thoracic CT scan
Time frame: 3 hours
Quantitative evaluation performed by thoracic CT scan of alveolar recruitment induced by NIV after cardiac surgery
Results and safety
The study was stopped early (reason given: internal recruitment difficulties and reorganization of the Intensive Care Units). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2018.
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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.
Elie ZOGHEIB, PhD principal investigator
CHU Amiens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thoracic Surgery, run by Centre Hospitalier Universitaire, Amiens 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 6 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: stopped early, as of the sponsor's last update on 1 Oct 2018. 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 was stopped early (reason given: internal recruitment difficulties and reorganization of the Intensive Care Units). 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?
Quantitative evaluation by thoracic CT scan (time frame: 3 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Oct 2018.