Overview

This trial is active, not recruiting.

Condition critical illness
Treatments rest in bed, passive verticalization
Sponsor Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Start date August 2014
End date May 2016
Trial size 10 participants
Trial identifier NCT02270762, Early passive verticalization

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)

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose diagnostic
Arm
(Experimental)
First evaluation of EIT with patient in bed at 30º of head inclination during 5 minutes.
rest in bed Basal position
(Experimental)
Second evaluation of EIT with patient in tilt table at 60º of verticalization during 10 minutes.
passive verticalization Tilt Table
(Experimental)
Last evaluation of EIT with patient in bed at 30º of head inclination during 20 minutes.
rest in bed Basal position

Primary Outcomes

Measure
Change in pulmonary electric impedance tomography (EIT) before, during and after single session of early passive verticalization
time frame: Meassure of EIT during 10 minutes of early passive verticalization and will compared with baseline EIT
Change in PaO2 before, during and after single session of early passive verticalization
time frame: Meassure of PaO2 after 20 minutes of passive verticalization and will compared with baseline PaO2

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Effect of Early Passive Verticalization in Pulmonary Recruitment Evaluated With Electric Impedance Tomography
Principal investigator Charlotte Meaux, PT
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by Cliniques universitaires Saint-Luc- Université Catholique de Louvain.