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

Not yet recruiting

Conditions

Intervention / Treatment

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

Observational

Enrollment (Estimated)

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 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

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
Intervention / Treatment
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

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

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

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)

March 1, 2024

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2027

Study Registration Dates

First Submitted

February 14, 2024

First Submitted That Met QC Criteria

February 22, 2024

First Posted (Actual)

February 29, 2024

Study Record Updates

Last Update Posted (Actual)

March 8, 2024

Last Update Submitted That Met QC Criteria

March 7, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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.

Clinical Trials on Subarachnoid Hemorrhage

Clinical Trials on lung ultrasound

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kosovo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe