NCT06286683

Brief Summary

The aim of the study is to evaluate the physiological response to out-of-bed mobilization in patients admitted to the intensive care unit for subarachnoid hemorrhage. More specifically, the aim is to measure the impact on cerebral perfusion, lung aeration, cardiovascular and respiratory parameters.

Trial Health

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Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
9mo left

Started Mar 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress75%
Mar 2024Feb 2027

First Submitted

Initial submission to the registry

February 14, 2024

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 29, 2024

Completed
1 day until next milestone

Study Start

First participant enrolled

March 1, 2024

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Last Updated

March 8, 2024

Status Verified

February 1, 2024

Enrollment Period

2.9 years

First QC Date

February 14, 2024

Last Update Submit

March 7, 2024

Conditions

Subarachnoid Hemorrhage

Keywords

Early mobilizationBrain perfusionTranscranial dopplerNear-infrared spectroscopyLung Ultrasound

Outcome Measures

Primary Outcomes (1)

  • Impact on lung aeration

    Lung Ultrasound Score by lung ultrasound, Ranging from 0 (normal lungs) to 36 (worst case scenario).

    at T0 before initiation of out-of-bed mobilization, and 15 minutes after moving to the chair.

Secondary Outcomes (7)

  • Impact on cerebral blood flow

    At T0 before initiation of out-of-bed mobilization, immediately after moving to the edge the bed, immediately after moving to the chair.

  • Impact on cerebral tissue oxygenation

    At T0 before initiation of out-of-bed mobilization, immediately after moving to the edge the bed, immediately after moving to the chair.

  • Impact on heart rate

    At T0 before initiation of out-of-bed mobilization, immediately after moving to the edge the bed, immediately after moving to the chair.

  • Impact on arterial pressure

    At T0 before initiation of out-of-bed mobilization, immediately after moving to the edge the bed, immediately after moving to the chair.

  • Impact on Saturation

    At T0 before initiation of out-of-bed mobilization, immediately after moving to the edge the bed, immediately after moving to the chair.

  • +2 more secondary outcomes

Study Arms (1)

Patients admitted to intensive care

Patients admitted to intensive care for aneurysmal subarachnoid hemorrhage (SAH) and eligible for their first out-of-bed mobilization

Device: lung ultrasoundDevice: Transcranial DopplerDevice: near-infrared spectroscopy (NIRS)Device: clinical examination

Interventions

lung ultrasoundDEVICE

Used to diagnose and monitor pulmonary aeration in the context of prolonged decubitus disorders (atelectasis) via the lung ultrasound score (LUS).

Patients admitted to intensive care
Transcranial DopplerDEVICE

Non-invasive, bedside method of measuring cerebral blood flow.

Patients admitted to intensive care
near-infrared spectroscopy (NIRS)DEVICE

Non-invasive, bedside method of cerebral oximetry that requires no advanced expertise.

Patients admitted to intensive care
clinical examinationDEVICE

clinical examination

Patients admitted to intensive care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients admitted to intensive care for aneurysmal subarachnoid hemorrhage (SAH) and eligible for their first outof-bed mobilization

You may qualify if:

  • Age ≥ 18 years
  • Aneurysmal SAH
  • Severity score World Federation Neurological Surgeons I to IV
  • Secured aneurysm
  • Eligible for their first early mobilization

You may not qualify if:

  • Sedated patient
  • Disturbed alertness, coma
  • Unsecured aneurysm
  • Patients under legal protection (guardianship, curatorship, safeguard of justice)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Adéla FOUDHAÏLI

Paris, 75010, France

Location

MeSH Terms

Conditions

Subarachnoid Hemorrhage

Interventions

Ultrasonography, Doppler, TranscranialSpectroscopy, Near-InfraredPhysical Examination

Condition Hierarchy (Ancestors)

Intracranial HemorrhagesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

EchoencephalographyNeuroradiographyNeuroimagingDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisRadiographyUltrasonographyUltrasonography, DopplerDiagnostic Techniques, NeurologicalInvestigative TechniquesSpectrum AnalysisChemistry Techniques, Analytical

Central Study Contacts

Adéla FOUDHAÏLI, Physiotherapist

CONTACT

0149956305adela.foudhaili@aphp.fr

Pr Benjamin Glenn CHOUSTERMAN

CONTACT

0149958518benjamin.chousterman@aphp.fr

Study Design

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

Study Record Dates

First Submitted

February 14, 2024

First Posted

February 29, 2024

Study Start

March 1, 2024

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2027

Last Updated

March 8, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)