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

Primary Purpose

Craniocerebral Trauma

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
portable scanner
fixed scanner
Sponsored by
Rennes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Craniocerebral Trauma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU Rennes

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

portable scanner

fixed scanner

Arm Description

Outcomes

Primary Outcome Measures

Time taken to perform a cranial scan

Secondary Outcome Measures

Full Information

First Posted
May 26, 2023
Last Updated
June 6, 2023
Sponsor
Rennes University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05891522
Brief Title
Pilot Study of the Use of a Portable Cranial Scanner in Intensive Care for Cerebro-injured Patients
Acronym
ESPER
Official Title
Pilot Study of the Use of a Portable Cranial Scanner in Intensive Care for Cerebro-injured Patients
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
June 25, 2019 (Actual)
Primary Completion Date
January 29, 2021 (Actual)
Study Completion Date
January 29, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rennes University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Craniocerebral Trauma

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
portable scanner
Arm Type
Experimental
Arm Title
fixed scanner
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
portable scanner
Intervention Description
performing a portable cranial scanner on cerebro-injured intensive care patients
Intervention Type
Procedure
Intervention Name(s)
fixed scanner
Intervention Description
performing a conventional fixed cranial scanner on cerebro-injured intensive care patients
Primary Outcome Measure Information:
Title
Time taken to perform a cranial scan
Time Frame
Day 0

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: admitted to intensive care for moderate or severe head trauma or severe meningeal haemorrhage (Glasgow score < or = 12); need for a brain scan; Exclusion Criteria: -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yoann Launey
Organizational Affiliation
CHU Rennes
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Rennes
City
Rennes
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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