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Craniocerebral TraumaESPERNCT05891522

Pilot Study of the Use of a Portable Cranial Scanner in Intensive Care for Cerebro-injured Patients

A study testing portable scanner and fixed scanner in people with Craniocerebral Trauma, run by Rennes University Hospital at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Cerebral scans are a key examination in the management of serious brain-injured patients in intensive care, and are often repeated in the initial phase. This is a critical clinical period for these fragile patients, who are likely to develop episodes of intracranial hypertension (ICHT), the duration of which is… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Craniocerebral Trauma
What is being tested?
portable scanner and fixed scanner
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
1 siteFrance
Study dates
25 Jun 2019to 29 Jan 2021
Phase
Interventional
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

Who may be able to join

  • admitted to intensive care for moderate or severe head trauma or severe meningeal haemorrhage (Glasgow score < or = 12);
  • need for a brain scan;

Who cannot join

  • -

Trial locations and contacts

1 site in 1 country.

France1 site
  • CHU Rennes

    Rennes

Other trials in France

About this study

Cerebral scans are a key examination in the management of serious brain-injured patients in intensive care, and are often repeated in the initial phase. This is a critical clinical period for these fragile patients, who are likely to develop episodes of intracranial hypertension (ICHT), the duration of which is correlated with a poor prognosis. These patients are therefore exposed to the complications of intra-hospital transport (IHT) (HTIC, hypoxaemia, arterial hypotension, disconnection of the respirator, respiratory asynchronies), which can worsen their vital and neurological prognosis. The incidence of adverse events linked to HIT has been estimated at up to 79.8%, including episodes of HTIC, worsening the prognosis and increasing the length of hospitalisation. In addition, patient safety during HIT requires the mobilisation of a doctor, a nurse and a care assistant, an organisation that implies a reduction in the care team's time with the other intensive care patients in their care. In this context, the portable cranial scanner, with imaging quality similar to that of conventional scanners, is already in routine use in the United States, the United Kingdom and Germany. This tool could reduce examination times, thereby reducing the risk of adverse events for the patient, in particular episodes of HTIC, and optimising the mobilisation of intensive care professionals. Studies suggest that the use of portable cranial scanners significantly reduces the duration of the examination (total duration including transport time) (50 minutes for conventional scanners versus 20 minutes for portable scanners), without altering the cerebral perfusion pressure or intracranial pressure of intensive care patients.

In addition, the use of portable scanners could generate savings for hospitals. In fact, in American and British teams where the use of portable scanners is widespread, several studies have shown that the time spent by radiology staff is reduced and the number of intensive care professionals mobilised is reduced compared with the use of conventional scanners. In addition, freeing up conventional scanner slots could lead to an increase in conventional scanner activity. For example, in a neurovascular emergency department environment at Massachusetts General Hospital, USA, the introduction of a mobile scanner reduced access time to the examination by 58% (39 minutes ±5.1 vs. 17 ±2.7 for conventional scanning), which also suggests faster implementation of emergency treatments such as the intravenous thrombolysis evaluated in this study. Finally, an American study carried out in 2008 estimated the financial gain generated by the use of a portable scanner versus a conventional scanner at more than 2 million dollars over 5 years and a complete return on investment of 7 months, from a hospital point of view.

To date, no French intensive care unit is using such a tool, even though the benefits appear to be real in terms of reducing the number of episodes of hypertensive haemorrhage and the prognostic impact this may have. The main aim of our pilot study is to assess the feasibility of using a portable brain scanner in cerebro-injured patients in intensive care by comparing the time taken to perform the portable examination with that of a conventional scanner. The investigators will also evaluate the existence and duration of HTIC episodes and the occurrence of any adverse events compared with a strategy based on a conventional fixed scanner.

Being tested
portable scanner, fixed scanner
Medical subject headings
Craniocerebral Trauma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • portable scannerProcedure or surgery

    performing a portable cranial scanner on cerebro-injured intensive care patients

  • fixed scannerProcedure or surgery

    performing a conventional fixed cranial scanner on cerebro-injured intensive care patients

Study groups in NCT05891522
Study groupRoleWhat they receive
portable scannerExperimentalNot described
Receives: Procedure: portable scanner
fixed scannerActive comparatorNot described
Receives: Procedure: fixed scanner

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time taken to perform a cranial scan

    Measured: Day 0

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jun 2023
  2. Study start25 Jun 2019
  3. Primary completion29 Jan 2021
  4. Study completion29 Jan 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
46 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05891522
Sponsor's protocol ID
35RC18_8960_ESPER
Other IDs
2018-A02723-52
Acronym
ESPER
Status last verified
May 2023
First submitted
26 May 2023
Last updated
8 Jun 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing portable scanner and fixed scanner in people with Craniocerebral Trauma, run by Rennes University Hospital 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 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 8 Jun 2023. 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?

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?

Time taken to perform a cranial scan (time frame: Day 0). 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 8 Jun 2023.

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