Hemodynamic ComplicationsICARHEMNCT07864259
Cardiovascular History and Hemodynamic Complications After Intubation in ICU
An observational study of Hemodynamic Complications, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
This retrospective single-center observational study aims to evaluate the association between a history of cardiovascular disease and the occurrence of severe hemodynamic complications within 30 minutes after intubation in adult patients admitted to the intensive care unit. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemodynamic Complications
- How many people
- 160 participants
- Where
- 1 siteFrance
- Study dates
- 13 Jan 2026to 13 Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Adult patients admitted to the intensive care unit at Strasbourg University Hospital who required intubation during the study period.
Who may be able to join
- Patient aged 18 years or older
- Patient hospitalized in intensive care unit between 01/01/2024 and 30/09/2025
- Patient requiring intubation in intensive care unit
- Absence of documented opposition to data reuse for research
Who cannot join
- Patient intubated for cardiac arrest
- Patient intubated outside intensive care unit
- Patient intubated under awake fiberoptic technique
- Patient under legal protection (guardianship or curatorship)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Service de Médecine Intensive - Réanimation - CHU de Strasbourg - France
Strasbourg, 67091
Max Max, MD, 33 3 88 12 79 13, max.guillot@chru-strasbourg.fr
Max Guillot, MD
About this study
Official title: Impact of Cardiovascular History on the Incidence of Severe Hemodynamic Complications Following Intubation in Intensive Care Units
This retrospective single-center observational study aims to evaluate the association between a history of cardiovascular disease and the occurrence of severe hemodynamic complications within 30 minutes after intubation in adult patients admitted to the intensive care unit. Cardiovascular history includes ischemic, arrhythmic, dilated or valvular heart disease, pulmonary hypertension, and systemic hypertension. Severe hemodynamic complications include severe hypotension, initiation or increase of norepinephrine, fluid resuscitation for hemodynamic instability, or cardiac arrest.
- Conditions
- Hemodynamic Complications
- Keywords
- Intensive Care Unit, Intubation, Cardiovascular Disease
- Medical subject headings
- Cardiovascular Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Severe hemodynamic complication after intubation
Occurrence of at least one severe hemodynamic complication within 30 minutes after intubation, including severe hypotension, catecholamine initiation or increase, fluid resuscitation, or cardiac arrest.
Measured: Within 30 minutes after intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2026
- Study start13 Jan 2026
- Primary completion13 Dec 2026 (estimated)
- Study completion13 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemodynamic ComplicationsStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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 only
- Time perspective
- Retrospective
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07864259
- Sponsor's protocol ID
- RC25_0068
- Acronym
- ICARHEM
- Status last verified
- Oct 2026
- First submitted
- 2 Oct 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Cardiovascular History on the Incidence of Severe Hemodynamic Complications Following Intubation in Intensive Care Units
- ClinicalTrials.gov ID
- NCT07864259
- Acronym / sponsor ID
- ICARHEM / RC25_0068
- Conditions
- Hemodynamic Complications
- Keywords
- Intensive Care Unit, Intubation, Cardiovascular Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 13 Jan 2026 (actual)
- Primary completion
- 13 Dec 2026 (estimated)
- Study completion
- 13 Jan 2027 (estimated)
- First posted
- 7 Oct 2026 (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.
This retrospective single-center observational study aims to evaluate the association between a history of cardiovascular disease and the occurrence of severe hemodynamic complications within 30 minutes after intubation in adult patients admitted to the intensive care unit. Cardiovascular history includes ischemic, arrhythmic, dilated or valvular heart disease, pulmonary hypertension, and systemic hypertension. Severe hemodynamic complications include severe hypotension, initiation or increase of norepinephrine, fluid resuscitation for hemodynamic instability, or cardiac arrest.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients admitted to the intensive care unit at Strasbourg University Hospital who required intubation during the study period.
Key inclusion criteria (4 listed)
- Patient aged 18 years or older
- Patient hospitalized in intensive care unit between 01/01/2024 and 30/09/2025
- Patient requiring intubation in intensive care unit
- Absence of documented opposition to data reuse for research
Key exclusion criteria (4 listed)
- Patient intubated for cardiac arrest
- Patient intubated outside intensive care unit
- Patient intubated under awake fiberoptic technique
- Patient under legal protection (guardianship or curatorship)
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
Severe hemodynamic complication after intubation
Time frame: Within 30 minutes after intubation
Occurrence of at least one severe hemodynamic complication within 30 minutes after intubation, including severe hypotension, catecholamine initiation or increase, fluid resuscitation, or cardiac arrest.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
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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.
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 Hemodynamic Complications, run by University Hospital, Strasbourg, France 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 4 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 7 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Max Guillot, MD (33 3 88 12 79 13, max.guillot@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severe hemodynamic complication after intubation (time frame: Within 30 minutes after intubation). 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 7 Oct 2026.