Early Passive Verticalization in Critically Ill Patients

Critical Illness Clinical Trial

— TILT  

Official title:

Effect of Early Passive Verticalization in Pulmonary Recruitment Evaluated With Electric Impedance Tomography

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02270762
• Other study ID #: Early passive verticalization
• Status: Active, not recruiting
• Phase: N/A
• First received: October 17, 2014
• Last updated: November 17, 2015
• Start date: August 2014
• Est. completion date: May 2016

Study information

• Verified date: November 2015
• Source: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review Board
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 10
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Critical Illness

Intervention

Other:
• Rest in bed

• Passive verticalization

• Rest in bed

Locations

Country	Name	City	State
Belgium	Cliniques universitaires Saint-Luc- Université Catholique de Louvain (StLuc)	Brussel

Sponsors (1)

Lead Sponsor	Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in pulmonary electric impedance tomography (EIT) before, during and after single session of early passive verticalization	The change in pulmonary recruitment will be evaluated with electrical impedance tomography (EIT) in single session of early passive verticalization. First measure will be made for five minutes with EIT, in bed; second measure will be made during passive verticalization for ten minutes with EIT and last measure will be made after verticalization for twenty minutes with EIT. All impedanciometries obtained in the patient in different activities will compare each.	Meassure of EIT during 10 minutes of early passive verticalization and will compared with baseline EIT	Yes
Primary	Change in PaO2 before, during and after single session of early passive verticalization	Before passive verticalization will be taken a sample of arterial blood gases for determinate the initial PaO2 of the patient. Twenty minutes after passive verticalization will be taken a new sample of arterial blood gases to establish the diference between PaO2 before verticalization and after verticalization	Meassure of PaO2 after 20 minutes of passive verticalization and will compared with baseline PaO2	Yes