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NCT Number: NCT06286683

Impact of Early Mobilization on SAH Patients Physiological Parameters

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.

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Key information

Conditions

Subarachnoid Hemorrhage Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Hemorrhage Intracranial Hemorrhages Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Adéla FOUDHAÏLI

Paris, 75010, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Lung ultrasound

Device

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

Transcranial Doppler

Device

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

Near-infrared spectroscopy (NIRS)

Device

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

clinical examination

Device

clinical examination

Primary outcomes

  1. 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

  1. 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.

    cerebral blood flow using average velocities on transcranial Doppler

  2. 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.

    cerebral tissue oxygenation via NIRS

  3. 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.

    Heart rate

  4. 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.

    Arterial pressure

  5. 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.

    Saturation

  6. 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.

    Glasgow Coma Scale score (scored between 3 and 15, 3 being the worst and 15 the best)

  7. 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.

    Numerical Pain Rating Scale (scored between 0 and 10, 0 being "no pain",10 "the worst pain imaginable")

Study contacts

Contact information is provided by the study sponsor or research team.

Adéla FOUDHAÏLI, Physiotherapist

CONTACT

[email protected]

0149956305

Pr Benjamin Glenn CHOUSTERMAN

CONTACT

[email protected]

0149958518

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Acronym: MOBALPAH

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Feb 29, 2024
Registry last updated
Mar 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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