Back to results

Early Passive Verticalization in Critically Ill Patients (TILT)

Primary Purpose

Critical Illness

Status

Unknown status

Phase

Not Applicable

Locations

Belgium

Study Type

Interventional

Intervention

Rest in bed

Passive verticalization

Rest in bed

About this trial

This is an interventional diagnostic trial for Critical Illness focused on measuring Early Physical Exercise, Early Passive Exercise, Alveolar Recruitment, Electrical Impedance Tomography, Oxygenation, Ventilation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

1) Rest in bed

2) Passive Verticalization

3) Rest in bed

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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.

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

Secondary Outcome Measures

Full Information

NCT ID

NCT02270762

First Posted

October 17, 2014

Last Updated

November 17, 2015

Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

1. Study Identification

Unique Protocol Identification Number

NCT02270762

Brief Title

Early Passive Verticalization in Critically Ill Patients

Acronym

TILT

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2015

Overall Recruitment Status

Unknown status

Study Start Date

August 2014 (undefined)

Primary Completion Date

May 2016 (Anticipated)

Study Completion Date

May 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Critical Illness

Keywords

Early Physical Exercise, Early Passive Exercise, Alveolar Recruitment, Electrical Impedance Tomography, Oxygenation, Ventilation

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

1) Rest in bed

Arm Type

Experimental

Arm Description

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

Arm Title

2) Passive Verticalization

Arm Type

Experimental

Arm Description

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

Arm Title

3) Rest in bed

Arm Type

Experimental

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Rest in bed

Other Intervention Name(s)

Basal position

Intervention Type

Other

Intervention Name(s)

Passive verticalization

Other Intervention Name(s)

Tilt Table, Early Passive verticalization, Early Assisted verticalization, Early physical therapy, Early physiotherapy

Intervention Type

Other

Intervention Name(s)

Rest in bed

Other Intervention Name(s)

Basal position

Primary Outcome Measure Information:

Title

Change in pulmonary electric impedance tomography (EIT) before, during and after single session of early passive verticalization

Description

Time Frame

Meassure of EIT during 10 minutes of early passive verticalization and will compared with baseline EIT

Title

Change in PaO2 before, during and after single session of early passive verticalization

Description

Time Frame

Meassure of PaO2 after 20 minutes of passive verticalization and will compared with baseline PaO2

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Charlotte Meaux, PT

Organizational Affiliation