Critical IllnessTIGRHOUNCT06455696
Intra-Hospital Transport of Critically Ill Patients in Intensive Care Unit
An observational study of Critical Illness and Transportation Accidents, run by French Society for Intensive Care at 1 site in France.
Trial summary
Intra-hospital transport is a frequent procedure in the ICU, involving patients with the highest severity scores. Although some studies estimate the rate of adverse events to be around 33% during intra-hospital transport, including 4% of serious adverse events, the epidemiological data available is small… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness, Transportation Accidents, Intensive Care Unit
- How many people
- 645 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2024to 30 Jun 2025
- 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: All patients hospitalized in an ICU and requiring an intra-hospital transport with a departure from ICU and arrival to ICU will be eligible.
Who may be able to join
- Patients aged over 18 years old
- Hospitalized in ICU
- Requiring an intra-hospital transport (e.g imagery, operating room, etc) by the ICU team
- With a departure from ICU and arrival to ICU
Who cannot join
- Person under guardianship
- Protected Majors
- Already included in the study
- Transport for an ICU discharge in a medical or surgical ward
- Transport with another team than the ICU team
- Not affiliated to French social security
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU de Strasbourg
Strasbourg
Raphaël CLERE-JEHL, +33 1 45 86 51 99, raphael.clere@gmail.com
About this study
Intra-hospital transport is a frequent procedure in the ICU, involving patients with the highest severity scores. Although some studies estimate the rate of adverse events to be around 33% during intra-hospital transport, including 4% of serious adverse events, the epidemiological data available is small, heterogeneous, and probably subject to methodological bias.
The aim of this study observational prospective observatoinal study is to determine:
- the different practices existing between ICUs ("practice survey")
- the occurrence of adverse events during intra-hospital transport provided by intensive care units (epidemiological study)
Read the detailed description
This is a multicenter prospective observational study on evaluation of practices between ICUs and to describe the occurence of adverse events during intra-hospital transport provided by ICUs (epidemiological study)
- Keywords
- Intra-hospital transport, Critical ill patients, Intensive care unit
- Medical subject headings
- Critical Illness
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events during intra-hospital transport in critical ill patients managed by an ICU team
The number of adverse events during intra-hospital transport managed by an ICU team, as a proportion of the number of transports performed.
Measured: During the intra-intrahospital transport [maximum 3 hours]
Secondary outcomes (2)
Incidence of non-serious adverse events occurring during intra-hospital transport.
- Rate of types of (non-serious) adverse events occurring during intra-hospital transport including O Rate of Withdrawal or mobilization of equipment with low risk of serious complication (e.g. VVP withdrawal, urinary catheter, nasogastric tube, mobilization of endotracheal tube without extubation) O Rate of Non-severe hemodynamic failures (occurrence of arterial hypotension with MAP between 40 and 65 mmHg, or catecholamine increase < 10% during transport) O Rate of Non-severe respiratory failure (desaturation with a SpO2 ≥ 80%) O Rate of Metabolic failure (e.g. hypoglycemia on return from transport) O Rate of Neurological complications (consciousness disorders occurring without sedation, agitation) O Rate of Material failures (O2 or ventilator failure, electrical syringe pump failure)
Measured: During the intra-intrahospital transport [maximum 3 hours]
Incidence of serious adverse events occurring during intra-hospital transport.
- Rate of serious adverse events occurring during intra-hospital transport including O Death O Cardiorespiratory arrest O Accidental extubation and/or need for re-intubation, or removal of high-risk equipment (e.g. central venous catheter, arterial catheter, endotracheal tube) O Severe hemodynamic failure (arterial hypotension with MAP < 40 mmHg, introduction or increase of catecholamines ≥ 10% during transport) O Severe respiratory failure (desaturation with SpO2 < 80% or massive inhalation)
Measured: During the intra-intrahospital transport [maximum 3 hours]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2024
- Study start1 Jan 2024
- Primary completion31 May 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies 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
- 645 participants (estimated)
Sponsor and investigators
- Lead sponsor
- French Society for Intensive Care
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06455696
- Sponsor's protocol ID
- 2023-A00866-39
- Acronym
- TIGRHOU
- Status last verified
- Jun 2024
- First submitted
- 27 May 2024
- Last updated
- 12 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-Hospital Transport of Critically Ill Patients in Intensive Care Unit
- ClinicalTrials.gov ID
- NCT06455696
- Acronym / sponsor ID
- TIGRHOU / 2023-A00866-39
- Keywords
- Intra-hospital transport, Critical ill patients, Intensive care unit
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 645 participants (estimated)
- Lead sponsor
- French Society for Intensive CareUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 May 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 12 Jun 2024 (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.
Intra-hospital transport is a frequent procedure in the ICU, involving patients with the highest severity scores. Although some studies estimate the rate of adverse events to be around 33% during intra-hospital transport, including 4% of serious adverse events, the epidemiological data available is small, heterogeneous, and probably subject to methodological bias.
The aim of this study observational prospective observatoinal study is to determine:
- the different practices existing between ICUs ("practice survey")
- the occurrence of adverse events during intra-hospital transport provided by intensive care units (epidemiological study)
Detailed description
This is a multicenter prospective observational study on evaluation of practices between ICUs and to describe the occurence of adverse events during intra-hospital transport provided by ICUs (epidemiological study)
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
- All patients hospitalized in an ICU and requiring an intra-hospital transport with a departure from ICU and arrival to ICU will be eligible.
Key inclusion criteria (4 listed)
- Patients aged over 18 years old
- Hospitalized in ICU
- Requiring an intra-hospital transport (e.g imagery, operating room, etc) by the ICU team
- With a departure from ICU and arrival to ICU
Key exclusion criteria (6 listed)
- Person under guardianship
- Protected Majors
- Already included in the study
- Transport for an ICU discharge in a medical or surgical ward
- Transport with another team than the ICU team
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
Incidence of adverse events during intra-hospital transport in critical ill patients managed by an ICU team
Time frame: During the intra-intrahospital transport [maximum 3 hours]
The number of adverse events during intra-hospital transport managed by an ICU team, as a proportion of the number of transports performed.
2 secondary outcomes
Incidence of non-serious adverse events occurring during intra-hospital transport.
Time frame: During the intra-intrahospital transport [maximum 3 hours]
Incidence of serious adverse events occurring during intra-hospital transport.
Time frame: During the intra-intrahospital transport [maximum 3 hours]
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2024.
- 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.
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 Critical Illness and Transportation Accidents, run by French Society for Intensive Care 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 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: status not confirmed, as of the sponsor's last update on 12 Jun 2024. 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 Raphaël CLERE-JEHL (+33 1 45 86 51 99, raphael.clere@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events during intra-hospital transport in critical ill patients managed by an ICU team (time frame: During the intra-intrahospital transport [maximum 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 12 Jun 2024.