Intensive Care, SurgicalPOCUSRNCT02979652
Can Point of Care Chest Ultrasound Predicts Pulmonary Complications After Major Surgery?
An observational study of Intensive Care, Surgical, run by Hospital Nord at 1 site in France.
Trial summary
This study is done to estimate prevalence of the main detectable lung and cardiovascular complications by an ultrasound realized in room of post-interventional supervision at the patients whose duration of general anesthesia is superior at one hour after a surgery to risk Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intensive Care, Surgical
- How many people
- 325 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2016to Jan 2018
- How long will I take part?
- 8 Days
- 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 hospatilized for a major surgery
Who may be able to join
- Physical status score > 1
- Anesthesia of duration > 1 hour
- Visceral, orthopaedic, vascular, thoracic surgery, neurosurgery
Who cannot join
- Technical incapacity of accessibility to the ultrasound window
- Cardiac or pulmonary transplant
Trial locations and contacts
1 site in 1 country.
Marc Leone, M.D contact
France1 site, 1 recruiting
- Recruiting
Departement anesthesie reanimation hopital nord
Marseille, 13015
Marc Leone, MD, mleone@ap-hm.fr
laurent Zieleskiewicz, MD, lZieleskiewicz@ap-hm.fr
About this study
This study is done to estimate prevalence of the main detectable lung and cardiovascular complications by an ultrasound realized in room of post-interventional supervision at the patients whose duration of general anesthesia is superior at one hour after a surgery to risk
- Conditions
- Intensive Care, Surgical
What is being measured
The primary outcome is the main question the study is designed to answer.
cardiac and pulmonary functions
cardiac and pulmonary functions will be evaluated by cardiac and pulmonary ultrasound exams for all patient whom have a more than 1 hour surgical intervention
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2016 (estimated)
- Study startApr 2016
- Primary completionNov 2017 (estimated)
- Study completionJan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intensive Care, SurgicalStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 325 participants (estimated)
- Target duration
- 8 Days
Sponsor and investigators
- Lead sponsor
- Hospital Nord
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc Leone, MD, Study director, Departement anesthesie reanimation hopital nord
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02979652
- Sponsor's protocol ID
- 00010254-2016 -016
- Acronym
- POCUSR
- Status last verified
- Nov 2016
- First submitted
- 24 Nov 2016
- Last updated
- 1 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Point of Care Chest Ultrasound Predicts Pulmonary Complications After Major Surgery?
- ClinicalTrials.gov ID
- NCT02979652
- Acronym / sponsor ID
- POCUSR / 00010254-2016 -016
- Conditions
- Intensive Care, Surgical
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 325 participants (estimated)
- Lead sponsor
- Hospital NordUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Nov 2017 (estimated)
- Study completion
- Jan 2018 (estimated)
- First posted
- 1 Dec 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.
This study is done to estimate prevalence of the main detectable lung and cardiovascular complications by an ultrasound realized in room of post-interventional supervision at the patients whose duration of general anesthesia is superior at one hour after a surgery to risk
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 8 Days
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients hospatilized for a major surgery
Key inclusion criteria (3 listed)
- Physical status score > 1
- Anesthesia of duration > 1 hour
- Visceral, orthopaedic, vascular, thoracic surgery, neurosurgery
Key exclusion criteria (2 listed)
- Technical incapacity of accessibility to the ultrasound window
- Cardiac or pulmonary transplant
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
cardiac and pulmonary functions
Time frame: 1 hour
cardiac and pulmonary functions will be evaluated by cardiac and pulmonary ultrasound exams for all patient whom have a more than 1 hour surgical intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2016.
- Individual participant dataSharing planned: No
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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.
Marc Leone, M.D contact
Marc Leone, MD study director
Departement anesthesie reanimation hopital nord
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 Intensive Care, Surgical, run by Hospital Nord 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 2 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: status not confirmed, as of the sponsor's last update on 1 Dec 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marc Leone, M.D (mleone@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cardiac and pulmonary functions (time frame: 1 hour). 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 Dec 2016.