Early Passive Verticalization in Critically Ill Patients

NCT02270762 | Unknown DMC

• 1 other identifier: Early passive verticalization
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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)

Conditions

Critical Illness

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (3)

1) Rest in bed

EXPERIMENTAL

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

Other: Rest in bed

2) Passive Verticalization

EXPERIMENTAL

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

Other: Passive verticalization

3) Rest in bed

EXPERIMENTAL

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

Other: Rest in bed

Interventions

Rest in bed OTHER

Also known as: Basal position

1) Rest in bed

Passive verticalization OTHER

Also known as: Tilt Table, Early Passive verticalization, Early Assisted verticalization, Early physical therapy, Early physiotherapy

2) Passive Verticalization

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain: lead

Study Sites (1)

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

Brussels, 1200, Belgium

Location

MeSH Terms

Conditions

Critical Illness; Motor Activity; Respiratory Aspiration

Interventions

RE1-silencing transcription factor; Beds

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior; Respiration Disorders; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Equipment and Supplies, Hospital; Equipment and Supplies

Study Officials

• 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)

  PRINCIPAL INVESTIGATOR

• Jean Roeseler, PT, PhD

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

  STUDY DIRECTOR

• Pierre-François Laterre, MD

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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2014
• First Posted: October 21, 2014
• Study Start: August 1, 2014
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: November 18, 2015

Record last verified: 2015-11

Locations

BE (1)