Comparison Between the IMPACT's Score and the Clinician's Perception to Predict the Prognosis of Severe and Moderate Traumatic Brain Injury

NCT ID: NCT03874546

Last Updated: 2021-10-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 83 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-04
• Study Completion Date: 2021-09-22

Brief Summary

Main objective : To compare the quality of the prognostic assessment, (adverse evolution at 6 months) of severe and moderate traumatic brain injury, performed by the clinician compared to the prognosis described by the IMPACT score.

The Pitié-Salpêtrière hospital is conducting a study evaluating the clinician's prognostic assessment of severe and moderate traumatic brain injury compared to the prognosis described by the IMPACT score. The investigators compare the quality of the clinician's prognostic assessment (adverse evolution at 6 months) of severe and moderate traumatic brain injury to the prognosis described by the IMPACT score.

Detailed Description

Design: Prospective, monocentric, pilot study. The study will be proposed to all patients admitted to the neurosurgical intensive care unit (ICU) at Pitié-Salpêtrière hospital, following a traumatic brain injury (TBI), over a period of 1 year. Around 100 patients will be included.

Day 1 : In the first 24 hours after traumatic brain injury, two clinicians will respond to the research questionnaire assessing their patient's prognosis, including confidence in their prediction and experience in neurological intensive care unit. The known prognostic variables as the IMPACT score in the first 24 hours will be collected.

Day 7 : The same clinicians will respond to the research questionnaire assessing their patient's prognosis, including confidence in their prediction and experience in neurological intensive care unit.

At 6 months : After 6 months, all patients or relatives will undergo a telephone interview (or if applicable during a follow-up visit in standard care) to assess the Glasgow Outcome Scale (GOS). This interview will be blinded to the clinician's prediction and the IMPACT score. For patients identified as GOS 3 or 4, a second GOS telephone interview will be carry out in the following days (<7 days), by a committee of adjudication composed of 2 examiners.

Conditions

Traumatic Brain Injury

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Prognostic evaluation

Questionnaire at Day1, Day7 and 6 months.

Group Type: EXPERIMENTAL

Questionnaire

Intervention Type: OTHER

• Two clinicians will complete a questionnaire that analyses their perception of the patient's prognosis at Day1 and Day7.
• At 6 months, another clinician will establish the patient prognosis using Glasgow Outcome Scale and Glasgow outcome scale extended. This clinician must not know the patient's IMPACT score and prognosis established at Day 1 and Day 7. His evaluation will be compare to the patient's prognosis established previously (Day1 and Day7).

Interventions

Questionnaire

• Two clinicians will complete a questionnaire that analyses their perception of the patient's prognosis at Day1 and Day7.
• At 6 months, another clinician will establish the patient prognosis using Glasgow Outcome Scale and Glasgow outcome scale extended. This clinician must not know the patient's IMPACT score and prognosis established at Day 1 and Day 7. His evaluation will be compare to the patient's prognosis established previously (Day1 and Day7).

Intervention Type: OTHER

Other Intervention Names

French language questionnaire for clinicians that analyses the clinician's perception of the patient's prognosis

Eligibility Criteria

Inclusion Criteria

• Patient aged 18 years or older,
• Hospitalized in the neurosurgical ICU department of the Pitié-Salpêtrière hospital following a head trauma,
• Presenting a Glasgow Coma Scale (GCS) ≤ 12 in the first 24 hours following the head trauma,
• Relatives informed of the research and not having objected to the patient's participation in the study.

Exclusion Criteria

• Opposition of the patient,
• Patient under the protection of justice,
• Pregnant woman,
• Modified scale of Rankin> 1 before the traumatic brain injury.
• Patient unable to speak French.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rémy BERNARD, MD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique Hoptiaux de Paris

Locations

Réanimation neurochirurgicale, Hôpital Pitié-Salpêtrière

Paris, , France

Countries

France

Other Identifiers

2018-A03135-50

Identifier Type: OTHER

Identifier Source: secondary_id

APHP180477

Identifier Type: -

Identifier Source: org_study_id