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Clinical Trials/NCT06286683
NCT06286683
Not yet recruiting
Not Applicable

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

Assistance Publique - Hôpitaux de Paris1 site in 1 country100 target enrollmentMarch 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Subarachnoid Hemorrhage
Sponsor
Assistance Publique - Hôpitaux de Paris
Enrollment
100
Locations
1
Primary Endpoint
Impact on lung aeration
Status
Not yet recruiting
Last Updated
2 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
March 2024
End Date
February 2027
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

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)

Outcomes

Primary Outcomes

Impact on lung aeration

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

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

Secondary Outcomes

  • Impact on neurological examination(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.)
  • 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 patient comfort(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 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.)

Study Sites (1)

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