Early Passive Verticalization in Critically Ill Patients

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

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2016-05-31

Brief Summary

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In the critically patient bed rest and inmovilization are some of the responsable of the development of respiratory complications. Early physical exercise is a tool to prevent respiratory complications as lost of respiratory muscle strength, decrease in functional residual capacity and hypoxemia improving oxygenation. In some cases critically ill conditions implies use of pharmacological sedation. That condition limit the active physical exercise. However, some technicals aids as Tilt table allows execution of passive early movilization.

The aim of this study is to assess the effect of early passive verticalization assisted by tilt table on alveolar recruitment and pulmonary ventilation in intensive care unit (ICU) patients, evaluated with electrical impedance tomography (EIT) ICU patients included at day of evaluation will be evaluated consecutively with EIT in three stages; 1) in the supine position (at 30° of inclination), 2) verticalized in tilt table (at 60º of inclination) 3) in the supine position (at 30° of inclination)

Detailed Description

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Conditions

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Critical Illness

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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1) Rest in bed

First evaluation of EIT with patient in bed at 30º of head inclination during 5 minutes.

Group Type EXPERIMENTAL

Rest in bed

Intervention Type OTHER

2) Passive Verticalization

Second evaluation of EIT with patient in tilt table at 60º of verticalization during 10 minutes.

Group Type EXPERIMENTAL

Passive verticalization

Intervention Type OTHER

3) Rest in bed

Last evaluation of EIT with patient in bed at 30º of head inclination during 20 minutes.

Group Type EXPERIMENTAL

Rest in bed

Intervention Type OTHER

Interventions

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Rest in bed

Intervention Type OTHER

Passive verticalization

Intervention Type OTHER

Rest in bed

Intervention Type OTHER

Other Intervention Names

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Basal position Tilt Table Early Passive verticalization Early Assisted verticalization Early physical therapy Early physiotherapy Basal position

Eligibility Criteria

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Inclusion Criteria

* Patient admitted at the Intensive Care Medical/Sirurgical Unite of Clinic Saint Luc
* Days of hospitalization between 1 and 10
* Hemodynamically stable
* Patient or family member sign the informed consent
* Sedated patients

Exclusion Criteria

* With risk of evisceration
* Therapy withdrawal
* With cardiac devices (Pace Maker)
* Persistent cough
* Patches or open wounds in zone of electrodes
* Presence of high vasopressor medication (noradrenaline \> 3 mg/h)
* PEEP \> 15 cm H2
* Acute Myocardial Infarction
* Active bleeding
* Intracranial pressure \> 20 mm Hg or with major inestability

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Charlotte Meaux, PT

Role: PRINCIPAL_INVESTIGATOR

Cliniques universitaires Saint-Luc- Université Catholique de Louvain (StLuc)

Cheryl E Hickmann, PT, PhD student

Role: PRINCIPAL_INVESTIGATOR

Cliniques universitaires Saint-Luc- Université Catholique de Louvain (StLuc)

Jean Roeseler, PT, PhD

Role: STUDY_DIRECTOR

Cliniques universitaires Saint-Luc- Université Catholique de Louvain (StLuc)

Pierre-François Laterre, MD

Role: STUDY_CHAIR

Cliniques universitaires Saint-Luc- Université Catholique de Louvain (StLuc)

Locations

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Cliniques universitaires Saint-Luc- Université Catholique de Louvain (StLuc)

Brussels, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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