Clinical trial NCT02226406: Effect of Early Physical Exercise on Pulmonary Ventilation and Recruitment
Official title: Effect of Early Physical Exercise on Pulmonary Ventilation and Recruitment Evaluated With Electric Impedance Tomography.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Critical Illness
Keywords: Early Physical Exercise
Alveolar Recruitment
Electrical Impedance Tomography
Oxygenation
Ventilation
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2014-08-27
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: In the critically patient bed rest and immobilization 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.

New technology as electrical impedance tomography (EIT) are available to visualize changes of regional lung aeration.

The aim of this study is to assess the effect of early physical exercise improving alveolar recruitment and pulmonary ventilation in intensive care unit (ICU) patients, evaluated with EIT.

The ICU patients included at day of evaluation will be evaluated continuously with EIT in different positions. 1) in the supine position (at 30° of inclination), 2) Sitting in chair 3) Active physical exercise 4) And rest in chair after exercise


Eligibility criteria: Inclusion Criteria:

* Patient admitted at the Intensive Care Medical/Surgical Unit of Clinic Saint Luc
* Days of hospitalization between 1 and 10
* Hemodynamically stable
* Patient or family member sign the informed consent

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 instability

Primary outcomes:
measure: Change in pulmonary electric impedance tomography (EIT) before, during and after single session of exercise.
timeFrame: Meassure of EIT after 10 minutes of exercise and will be compared with baseline EIT
Secondary outcomes:
measure: Change in PaO2 before, during and after single session of exercise
timeFrame: Measure of PaO2 after 20 minutes of exercise and will compared with baseline PaO2
Other outcomes:
Locations:
city: Brussel
country: Belgium
facility: Cliniques universitaires Saint-Luc- Université Catholique de Louvain (StLuc)
Study officials:
affiliation: Cliniques universitaires Saint-Luc- Université Catholique de Louvain (StLuc)
name: Ricardo Arriagada, PT
role: PRINCIPAL_INVESTIGATOR
affiliation: Cliniques universitaires Saint-Luc- Université Catholique de Louvain (StLuc)
name: Ursula Jeria, PT
role: PRINCIPAL_INVESTIGATOR
affiliation: Cliniques universitaires Saint-Luc- Université Catholique de Louvain (StLuc)
name: Cheryl Hickmann, PT, PhD student
role: PRINCIPAL_INVESTIGATOR
affiliation: Cliniques universitaires Saint-Luc- Université Catholique de Louvain (StLuc)
name: Jean Roeseler, PT, PhD
role: STUDY_DIRECTOR
affiliation: Cliniques universitaires Saint-Luc- Université Catholique de Louvain (StLuc)
name: Pierre-François Laterre, MD
role: STUDY_CHAIR
References: