Subarachnoid HemorrhageMOBALPAHNCT06286683
Impact of Early Mobilization on SAH Patients Physiological Parameters
An observational study of Subarachnoid Hemorrhage, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Subarachnoid Hemorrhage
- What is being tested?
- lung ultrasound, Transcranial Doppler and near-infrared spectroscopy (NIRS)
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2024to Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted to intensive care for aneurysmal subarachnoid hemorrhage (SAH) and eligible for their first outof-bed mobilization
Who may be able to join
- Age ≥ 18 years
- Aneurysmal SAH
- Severity score World Federation Neurological Surgeons I to IV
- Secured aneurysm
- Eligible for their first early mobilization
Who cannot join
- Sedated patient
- Disturbed alertness, coma
- Unsecured aneurysm
- Patients under legal protection (guardianship, curatorship, safeguard of justice)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Impact of Early Out-of-bed Mobilization on Physiological Parameters of Patients Admitted to Intensive Care for Subarachnoid Hemorrhage
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.
Read the 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.
- Conditions
- Subarachnoid Hemorrhage
- Being tested
- lung ultrasound, Transcranial Doppler, near-infrared spectroscopy (NIRS), clinical examination
- Keywords
- Early mobilization, Brain perfusion, Transcranial doppler, Near-infrared spectroscopy, Lung Ultrasound
- Medical subject headings
- Subarachnoid Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lung ultrasoundDevice
Used to diagnose and monitor pulmonary aeration in the context of prolonged decubitus disorders (atelectasis) via the lung ultrasound score (LUS).
Transcranial DopplerDevice
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 examinationDevice
clinical examination
| Study group | Role | What they receive |
|---|---|---|
| Patients admitted to intensive care | Patients admitted to intensive care for aneurysmal subarachnoid hemorrhage (SAH) and eligible for their first out-of-bed mobilization Receives: Device: lung ultrasound; Device: Transcranial Doppler; Device: near-infrared spectroscopy (NIRS); Device: clinical examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact on lung aeration
Lung Ultrasound Score by lung ultrasound, Ranging from 0 (normal lungs) to 36 (worst case scenario).
Measured: at T0 before initiation of out-of-bed mobilization, and 15 minutes after moving to the chair.
Secondary outcomes (7)
Impact on cerebral blood flow
cerebral blood flow using average velocities on transcranial Doppler
Measured: 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
cerebral tissue oxygenation via NIRS
Measured: 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
Heart rate
Measured: 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
Arterial pressure
Measured: 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
Saturation
Measured: 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
Glasgow Coma Scale score (scored between 3 and 15, 3 being the worst and 15 the best)
Measured: 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
Numerical Pain Rating Scale (scored between 0 and 10, 0 being "no pain",10 "the worst pain imaginable")
Measured: At T0 before initiation of out-of-bed mobilization, immediately after moving to the edge the bed, immediately after moving to the chair.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2024
- Study startMar 2024 (estimated)
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subarachnoid HemorrhageStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06286683
- Sponsor's protocol ID
- APHP231706
- Acronym
- MOBALPAH
- Status last verified
- Feb 2024
- First submitted
- 14 Feb 2024
- Last updated
- 8 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Early Out-of-bed Mobilization on Physiological Parameters of Patients Admitted to Intensive Care for Subarachnoid Hemorrhage
- ClinicalTrials.gov ID
- NCT06286683
- Acronym / sponsor ID
- MOBALPAH / APHP231706
- Conditions
- Subarachnoid Hemorrhage
- Keywords
- Early mobilization, Brain perfusion, Transcranial doppler, Near-infrared spectroscopy, Lung Ultrasound
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Mar 2024 (estimated)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 29 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients admitted to intensive care | – | Device: lung ultrasound, Device: Transcranial Doppler, Device: near-infrared spectroscopy (NIRS), Device: clinical examinationPatients admitted to intensive care for aneurysmal subarachnoid hemorrhage (SAH) and eligible for their first out-of-bed mobilization |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to intensive care for aneurysmal subarachnoid hemorrhage (SAH) and eligible for their first outof-bed mobilization
Key inclusion criteria (5 listed)
- Age ≥ 18 years
- Aneurysmal SAH
- Severity score World Federation Neurological Surgeons I to IV
- Secured aneurysm
- Eligible for their first early mobilization
Key exclusion criteria (4 listed)
- Sedated patient
- Disturbed alertness, coma
- Unsecured aneurysm
- Patients under legal protection (guardianship, curatorship, safeguard of justice)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lung ultrasoundUsed to diagnose and monitor pulmonary aeration in the context of prolonged decubitus disorders (atelectasis) via the lung ultrasound score (LUS). | Device | Patients admitted to intensive care |
| Transcranial DopplerNon-invasive, bedside method of measuring cerebral blood flow. | Device | Patients admitted to intensive care |
| near-infrared spectroscopy (NIRS)Non-invasive, bedside method of cerebral oximetry that requires no advanced expertise. | Device | Patients admitted to intensive care |
| clinical examinationclinical examination | Device | Patients admitted to intensive care |
Primary outcome
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).
7 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Subarachnoid Hemorrhage, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Adéla FOUDHAÏLI, Physiotherapist (0149956305, adela.foudhaili@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact on lung aeration (time frame: at T0 before initiation of out-of-bed mobilization, and 15 minutes after moving to the chair.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2024.