Critically IllNCT01952262
Ultrasound of the Diaphragm in ICU Patients
An observational study of Critically Ill, run by Università Vita-Salute San Raffaele at 1 site in Italy.
Trial summary
Diaphragmatic dysfunction is an important complication of mechanical ventilation. Critically ill patients admitted in a teaching hospital intensive care unit will be evaluated with diaphragm ultrasound to investigate predictors of diaphragmatic dysfunction and the clinical course of these patients. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Critically Ill
- What is being tested?
- diaphragm ultrasound
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- May 2013to Dec 2022
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult critically ill patients
Who may be able to join
- adult plus admitted in ICU plus invasive or non-invasive mechanical ventilation or
- adults aortic vascular surgery
Who cannot join
- < 18 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound Evaluation of Diaphragmatic Dysfunction in Critically Ill Patients. An Observational Study.
Diaphragmatic dysfunction is an important complication of mechanical ventilation. Critically ill patients admitted in a teaching hospital intensive care unit will be evaluated with diaphragm ultrasound to investigate predictors of diaphragmatic dysfunction and the clinical course of these patients.
Vascular surgery patients (aortic abdominal surgery) might also be included and assessed with diaphragm ultrasound before and after surgery irrespectively of the need of intensive care unit. On December 2014 the Etical committee approved an amendment to include the possibility to study elective aortic abdominal surgery patient to assess the relationship between surgery related diaphragmatic dysfunction and postoperative respiratory complications.
- Conditions
- Critically Ill
- Being tested
- diaphragm ultrasound
- Keywords
- ultrasound, diaphragm, intensive care, critical care
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diaphragm ultrasoundOther
Also called echography of diaphragm
we'll perform diaphragm ultrasound in ICU critically ill patients
| Study group | Role | What they receive |
|---|---|---|
| critically ill ICU patients | critically ill intensive care unit patients Receives: Other: diaphragm ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diaphragmatic dysfunction
Diaphragmatic dysfunction will be measured as thickness and inspiratory excursion of the diaphragm
Measured: participants will be followed for the duration of intensive care unit stay, an expected average of 1 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2013 (estimated)
- Study startMay 2013
- Primary completionDec 2022
- Study completionDec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critically IllStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Università Vita-Salute San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giovanni Landoni, Università Vita-Salute San Raffaele
- Investigators
- Massimo Zambon, MD, Principal investigator, San Raffaele Scientific Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01952262
- Sponsor's protocol ID
- OSR/39/05/13
- Status last verified
- Dec 2022
- First submitted
- 2 Aug 2013
- Last updated
- 27 Dec 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Evaluation of Diaphragmatic Dysfunction in Critically Ill Patients. An Observational Study.
- ClinicalTrials.gov ID
- NCT01952262
- Acronym / sponsor ID
- OSR/39/05/13
- Conditions
- Critically Ill
- Keywords
- ultrasound, diaphragm, intensive care, critical care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Università Vita-Salute San RaffaeleUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Dec 2022 (actual)
- Study completion
- Dec 2022 (actual)
- First posted
- 27 Sep 2013 (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.
Diaphragmatic dysfunction is an important complication of mechanical ventilation. Critically ill patients admitted in a teaching hospital intensive care unit will be evaluated with diaphragm ultrasound to investigate predictors of diaphragmatic dysfunction and the clinical course of these patients.
Vascular surgery patients (aortic abdominal surgery) might also be included and assessed with diaphragm ultrasound before and after surgery irrespectively of the need of intensive care unit. On December 2014 the Etical committee approved an amendment to include the possibility to study elective aortic abdominal surgery patient to assess the relationship between surgery related diaphragmatic dysfunction and postoperative respiratory complications.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| critically ill ICU patients | – | Other: diaphragm ultrasoundcritically ill intensive care unit patients |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult critically ill patients
Key inclusion criteria (2 listed)
- adult plus admitted in ICU plus invasive or non-invasive mechanical ventilation or
- adults aortic vascular surgery
Key exclusion criteria (1 listed)
- < 18 years
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 |
|---|---|---|
| diaphragm ultrasoundAlso: echography of diaphragmwe'll perform diaphragm ultrasound in ICU critically ill patients | Other | critically ill ICU patients |
Primary outcome
Diaphragmatic dysfunction
Time frame: participants will be followed for the duration of intensive care unit stay, an expected average of 1 weeks
Diaphragmatic dysfunction will be measured as thickness and inspiratory excursion of the diaphragm
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 27 Dec 2022.
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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.
Massimo Zambon, MD principal investigator
San Raffaele Scientific Institute
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 Critically Ill, run by Università Vita-Salute San Raffaele at 1 site in Italy.
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 2 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 27 Dec 2022. 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 Italy. 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?
Diaphragmatic dysfunction (time frame: participants will be followed for the duration of intensive care unit stay, an expected average of 1 weeks). 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 27 Dec 2022.