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Not yet recruiting NCT06286683

Impact of Early Mobilization on SAH Patients Physiological Parameters

Observational Subarachnoid Hemorrhage

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: lung ultrasound, Transcranial Doppler, near-infrared spectroscopy (NIRS), clinical examination.
Who it may be relevant to
Registry conditions: Subarachnoid Hemorrhage. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Impact of Early Out-of-bed Mobilization on Physiological Parameters of Patients Admitted to Intensive Care for Subarachnoid Hemorrhage

Overview

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.

Detailed description

In patients with subarachnoid hemorrhage, the mobilization strategy has been little studied. Several studies have already evaluated the consequences of mobilization in bed. Because of the deleterious consequences of prolonged bed rest, and in line with recommendations, practices have evolved towards early out-of-bed mobilization, which has shown benefits. However, the physiological consequences of out-of-bed mobilization have not yet been assessed. The aim of this study is to measure the impact of early out-of-bed mobilization of patients admitted for SAH on neuro-cardio-pulmonary physiological parameters.

Interventions

  • Device lung ultrasound
    Used to diagnose and monitor pulmonary aeration in the context of prolonged decubitus disorders (atelectasis) via the lung ultrasound score (LUS).
  • Device Transcranial Doppler
    Non-invasive, bedside method of measuring cerebral blood flow.
  • Device near-infrared spectroscopy (NIRS)
    Non-invasive, bedside method of cerebral oximetry that requires no advanced expertise.
  • Device clinical examination
    clinical examination

Primary outcome measures

  • Impact on lung aeration [Time frame: at T0 before initiation of out-of-bed mobilization, and 15 minutes after moving to the chair.]
Secondary outcome measures (7)
  • Impact on cerebral blood flow [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 neurological examination [Time frame: 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 patient comfort [Time frame: At T0 before initiation of out-of-bed mobilization, immediately after moving to the edge the bed, immediately after moving to the chair.]

Eligibility criteria

Inclusion criteria

Age ≥ 18 years

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

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 1 center
  • Adéla FOUDHAÏLI — Paris

Identifiers

NCT: NCT06286683 · APHP231706

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗