Impact of Early Mobilization on SAH Patients Physiological Parameters

NCT ID: NCT06286683

Last Updated: 2024-03-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-03-31

Study Completion Date

2027-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Subarachnoid Hemorrhage

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patients admitted to intensive care

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

lung ultrasound

Intervention Type DEVICE

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

Transcranial Doppler

Intervention Type DEVICE

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

near-infrared spectroscopy (NIRS)

Intervention Type DEVICE

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

clinical examination

Intervention Type DEVICE

clinical examination

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

lung ultrasound

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

Intervention Type DEVICE

Transcranial Doppler

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

Intervention Type DEVICE

near-infrared spectroscopy (NIRS)

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

Intervention Type DEVICE

clinical examination

clinical examination

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Adéla FOUDHAÏLI

Paris, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Adéla FOUDHAÏLI, Physiotherapist

Role: CONTACT

0149956305

Pr Benjamin Glenn CHOUSTERMAN

Role: CONTACT

0149958518

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

APHP231706

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.