IntubationEPICNCT03184207
A Systematic Echography During Intubation Procedure to Predict Cardiovascular Collapse
An observational study of Intubation, run by University Hospital, Brest at 3 sites in France.
Trial summary
In the operating room, most intubation procedures (IP) are scheduled and performed on hemodynamically stable patients. In the ICU, IP is frequently performed in emergent patients, because of unstable hemodynamics and/or acute respiratory failure, and complicated by a subsequent cardiovascular collapse. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intubation
- How many people
- 70 participants
- Where
- 3 sitesFrance
- Study dates
- 21 Jun 2017to 19 Oct 2018
- 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: Patient admitted to ICU
Who may be able to join
- Patient requiring endotracheal intubation
Who cannot join
- Age < 18 yrs
- Pregnancy
- Amputation of a lower limb
- Passing leg raising contraindication: intracranial hypertension with invasive monitoring, fracture of the pelvis or limbs
- Patients under administrative protective measures
- Severe cardiovascular collapse before intubation
- Severe cardiogenic pulmonary oedema
Trial locations and contacts
3 sites in 1 country.
France3 sites
Hôpital d'Instruction des Armées Clermont Tonnerre
Brest, 29200
CHRU de Brest
Brest, 29609
Centre Hospitalier des Pays de Morlaix
Morlaix, 29672
About this study
Official title: A Systematic Ultrasound Assessment During Intubation Procedure to Predict Cardiovascular Collapse Related to Intubation in the Intensive Care Unit: a Prospective, Multiple-center Study
In the operating room, most intubation procedures (IP) are scheduled and performed on hemodynamically stable patients. In the ICU, IP is frequently performed in emergent patients, because of unstable hemodynamics and/or acute respiratory failure, and complicated by a subsequent cardiovascular collapse. Transthoracic echocardiography (TTE) has become readily available in most ICUs for several years. Echocardiography enables to perform a noninvasive hemodynamic evaluation (cardiac function and volemia status).
We hypothesized that performing a TTE prior to IP may help to predict cardiovascular collapse and its components.
- Conditions
- Intubation
What is being measured
The primary outcome is the main question the study is designed to answer.
Subsequent cardiovascular collapse related to intubation
Mean arterial pressure drop < 60 mmHg
Measured: Within 15 minutes of intubation
Secondary outcomes (1)
Ultrasound parameters to predict fluid responsiveness
Transthoracic echocardiography parameters to predict fluid responsiveness
Measured: 30 minutes before intubation, less than 30 minutes after intubation, 1 minutes after lifting legs and 3 hours after intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2017
- Study start21 Jun 2017
- Primary completion21 Jun 2017
- Study completion19 Oct 2018
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 IntubationStudies 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
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- JEAN-MICHEL Vanessa, M.D., Principal investigator, CHRU Brest Hospital Brittany Occidental University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03184207
- Sponsor's protocol ID
- EPIC ( 29BRC17.0047)
- Acronym
- EPIC
- Status last verified
- Jul 2019
- First submitted
- 13 Apr 2017
- Last updated
- 13 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Jaber S, Jung B, Corne P, Sebbane M, Muller L, Chanques G, Verzilli D, Jonquet O, Eledjam JJ, Lefrant JY. An intervention to decrease complications related to endotracheal intubation in the intensive care unit: a prospective, multiple-center study. Intensive Care Med. 2010 Feb;36(2):248-55. doi: 10.1007/s00134-009-1717-8. Epub 2009 Nov 17.
PubMed 19921148
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Systematic Ultrasound Assessment During Intubation Procedure to Predict Cardiovascular Collapse Related to Intubation in the Intensive Care Unit: a Prospective, Multiple-center Study
- ClinicalTrials.gov ID
- NCT03184207
- Acronym / sponsor ID
- EPIC / EPIC ( 29BRC17.0047)
- Conditions
- Intubation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 21 Jun 2017 (actual)
- Primary completion
- 21 Jun 2017 (actual)
- Study completion
- 19 Oct 2018 (actual)
- First posted
- 12 Jun 2017 (actual)
- 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 the operating room, most intubation procedures (IP) are scheduled and performed on hemodynamically stable patients. In the ICU, IP is frequently performed in emergent patients, because of unstable hemodynamics and/or acute respiratory failure, and complicated by a subsequent cardiovascular collapse. Transthoracic echocardiography (TTE) has become readily available in most ICUs for several years. Echocardiography enables to perform a noninvasive hemodynamic evaluation (cardiac function and volemia status).
We hypothesized that performing a TTE prior to IP may help to predict cardiovascular collapse and its components.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient admitted to ICU
Key inclusion criteria (1 listed)
- Patient requiring endotracheal intubation
Key exclusion criteria (7 listed)
- Age < 18 yrs
- Pregnancy
- Amputation of a lower limb
- Passing leg raising contraindication: intracranial hypertension with invasive monitoring, fracture of the pelvis or limbs
- Patients under administrative protective measures
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
Subsequent cardiovascular collapse related to intubation
Time frame: Within 15 minutes of intubation
Mean arterial pressure drop < 60 mmHg
1 secondary outcome
Ultrasound parameters to predict fluid responsiveness
Time frame: 30 minutes before intubation, less than 30 minutes after intubation, 1 minutes after lifting legs and 3 hours after intubation
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 13 Aug 2019.
- Background: PubMed 19921148Jaber S, Jung B, Corne P, Sebbane M, Muller L, Chanques G, Verzilli D, Jonquet O, Eledjam JJ, Lefrant JY. An intervention to decrease complications related to endotracheal intubation in the intensive care unit: a prospective, multiple-center study. Intensive Care Med. 2010 Feb;36(2):248-55. doi: 10.1007/s00134-009-1717-8. Epub 2009 Nov 17.
- Individual participant dataSharing planned: Undecided
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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.
JEAN-MICHEL Vanessa, M.D. principal investigator
CHRU Brest Hospital Brittany Occidental University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intubation, run by University Hospital, Brest at 3 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 1 inclusion and 7 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 13 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Subsequent cardiovascular collapse related to intubation (time frame: Within 15 minutes of intubation). 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 NCT03184207, 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 13 Aug 2019.