Impact of Early Mobilization on SAH Patients Physiological Parameters (MOBALPAH)

March 7, 2024 updated by: Assistance Publique - Hôpitaux de Paris

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Paris, France, 75010
        • Adéla FOUDHAÏLI

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Patients admitted to intensive care
Patients admitted to intensive care for aneurysmal subarachnoid hemorrhage (SAH) and eligible for their first out-of-bed mobilization
Device: lung ultrasound
Used to diagnose and monitor pulmonary aeration in the context of prolonged decubitus disorders (atelectasis) via the lung ultrasound score (LUS).
Device: Transcranial Doppler
Non-invasive, bedside method of measuring cerebral blood flow.
Device: near-infrared spectroscopy (NIRS)
Non-invasive, bedside method of cerebral oximetry that requires no advanced expertise.
Device: clinical examination
clinical examination

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
at T0 before initiation of out-of-bed mobilization, and 15 minutes after moving to the chair.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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.
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.
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
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.
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
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
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.
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.
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")
At T0 before initiation of out-of-bed mobilization, immediately after moving to the edge the bed, immediately after moving to the chair.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assistance Publique - Hôpitaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 14, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 22, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 29, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 8, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 7, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • APHP231706

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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