Early Passive Verticalization in Critically Ill Patients (TILT)

November 17, 2015 updated by: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

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

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)

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussel, Belgium, 1200
        • Cliniques universitaires Saint-Luc- Université Catholique de Louvain (StLuc)

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 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

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1) Rest in bed
First evaluation of EIT with patient in bed at 30º of head inclination during 5 minutes.
Other: Rest in bed
Other Names:
  • Basal position
Experimental: 2) Passive Verticalization
Second evaluation of EIT with patient in tilt table at 60º of verticalization during 10 minutes.
Other: Passive verticalization
Other Names:
  • Early physical therapy
  • Early physiotherapy
  • Tilt Table
  • Early Passive verticalization
  • Early Assisted verticalization
Experimental: 3) Rest in bed
Last evaluation of EIT with patient in bed at 30º of head inclination during 20 minutes.
Other: Rest in bed
Other Names:
  • Basal position

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Investigators

  • Study Director: Jean Roeseler, PT, PhD, Cliniques universitaires Saint-Luc- Université Catholique de Louvain (StLuc)
  • Study Chair: Pierre-François Laterre, MD, Cliniques universitaires Saint-Luc- Université Catholique de Louvain (StLuc)
  • Principal Investigator: Charlotte Meaux, PT, Cliniques universitaires Saint-Luc- Université Catholique de Louvain (StLuc)
  • Principal Investigator: Cheryl E Hickmann, PT, PhD student, Cliniques universitaires Saint-Luc- Université Catholique de Louvain (StLuc)

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

August 1, 2014

Primary Completion (Anticipated)

May 1, 2016

Study Completion (Anticipated)

May 1, 2016

Study Registration Dates

First Submitted

October 17, 2014

First Submitted That Met QC Criteria

October 17, 2014

First Posted (Estimate)

October 21, 2014

Study Record Updates

Last Update Posted (Estimate)

November 18, 2015

Last Update Submitted That Met QC Criteria

November 17, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Early passive verticalization

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.

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