Clinical trial NCT02270762: Early Passive Verticalization in Critically Ill Patients
Official title: Effect of Early Passive Verticalization in Pulmonary Recruitment Evaluated With Electric Impedance Tomography
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Critical Illness
Keywords: Early Physical Exercise
Early Passive Exercise
Alveolar Recruitment
Electrical Impedance Tomography
Oxygenation
Ventilation
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2014-10-21
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 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)


Eligibility criteria: 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

Primary outcomes:
measure: Change in pulmonary electric impedance tomography (EIT) before, during and after single session of early passive verticalization
timeFrame: Meassure of EIT during 10 minutes of early passive verticalization and will compared with baseline EIT
measure: Change in PaO2 before, during and after single session of early passive verticalization
timeFrame: Meassure of PaO2 after 20 minutes of passive verticalization and will compared with baseline PaO2
Secondary outcomes:
Other outcomes:
Locations:
city: Brussel
country: Belgium
facility: Cliniques universitaires Saint-Luc- Université Catholique de Louvain (StLuc)
Study officials:
affiliation: Cliniques universitaires Saint-Luc- Université Catholique de Louvain (StLuc)
name: Charlotte Meaux, PT
role: PRINCIPAL_INVESTIGATOR
affiliation: Cliniques universitaires Saint-Luc- Université Catholique de Louvain (StLuc)
name: Cheryl E Hickmann, PT, PhD student
role: PRINCIPAL_INVESTIGATOR
affiliation: Cliniques universitaires Saint-Luc- Université Catholique de Louvain (StLuc)
name: Jean Roeseler, PT, PhD
role: STUDY_DIRECTOR
affiliation: Cliniques universitaires Saint-Luc- Université Catholique de Louvain (StLuc)
name: Pierre-François Laterre, MD
role: STUDY_CHAIR
References: