NCT06039098

Brief Summary

We aim to acquire data using DCS on patients who are undergoing invasive ICP and ABP monitoring on ITU as part of their normal treatment. Data will then be correlated to derive various parameters including CBF and BFI. All interventions are entirely non-invasive.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 5, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2023

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

September 8, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 15, 2023

Completed
Last Updated

February 20, 2024

Status Verified

February 1, 2024

Enrollment Period

8 months

First QC Date

September 8, 2023

Last Update Submit

February 16, 2024

Conditions

Traumatic Brain InjuryIntracranial Hypertension

Outcome Measures

Primary Outcomes (1)

  • DCS signal acquisition

    Successful acquisition of DCS signals from brain tissue

    12 months

Secondary Outcomes (2)

  • Correlation of DCS signals with routine physiological data measurements

    10 months

  • ML approach to derive secondary parameters

    10 months

Study Arms (1)

Participants

Participants are patients who are undergoing invasive ICP and ABP measurement as part of their normal medical treatment.

Device: DCS

Interventions

DCSDEVICE

DCS monitoring of brain

Participants

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The largest demographic of patients undergoing ICP monitoring is trauma, therefore the study population is patients who have suffered TBI and are undergoing ICP monitoring on ITU.

You may qualify if:

  • Invasive monitoring of ICP and ABP as part of normal treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal London Hospital

London, United Kingdom

Location

MeSH Terms

Conditions

Brain Injuries, TraumaticIntracranial Hypertension

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2023

First Posted

September 15, 2023

Study Start

January 5, 2023

Primary Completion

August 20, 2023

Study Completion

August 20, 2023

Last Updated

February 20, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will share

Data will be shared with organizations / individuals upon reasonable request.

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
Once data have been acquired
Access Criteria
Upon reasonable request to be determined by the CI.

Locations

GB(1)