Impact of Early Mobilization on SAH Patients Physiological Parameters

Subarachnoid Hemorrhage Clinical Trial

— MOBALPAH  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06286683
• Other study ID #: APHP231706
• Status: Not yet recruiting
• Start date: March 2024
• Est. completion date: February 2027

Study information

• Verified date: February 2024
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Adéla FOUDHAÏLI, Physiotherapist
• Phone: 0149956305
• Email: adela.foudhaili[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: February 2027
• Est. primary completion date: February 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Hemorrhage
• Subarachnoid Hemorrhage

Intervention

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

Locations

Country	Name	City	State
France	Adéla FOUDHAÏLI	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Impact on cerebral blood flow	cerebral blood flow using average velocities on transcranial Doppler	At T0 before initiation of out-of-bed mobilization, immediately after moving to the edge the bed, immediately after moving to the chair.
Secondary	Impact on cerebral tissue oxygenation	cerebral tissue oxygenation via NIRS	At T0 before initiation of out-of-bed mobilization, immediately after moving to the edge the bed, immediately after moving to the chair.
Secondary	Impact on heart rate	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.
Secondary	Impact on arterial pressure	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.
Secondary	Impact on Saturation	Saturation	At T0 before initiation of out-of-bed mobilization, immediately after moving to the edge the bed, immediately after moving to the chair.
Secondary	Impact on neurological examination	Glasgow Coma Scale score (scored between 3 and 15, 3 being the worst and 15 the best)	At T0 before initiation of out-of-bed mobilization, immediately after moving to the edge the bed, immediately after moving to the chair.
Secondary	Impact on patient comfort	Numerical Pain Rating Scale (scored between 0 and 10, 0 being "no pain",10 "the worst pain imaginable")	At T0 before initiation of out-of-bed mobilization, immediately after moving to the edge the bed, immediately after moving to the chair.