Critical IllnessTILTNCT02270762
Early Passive Verticalization in Critically Ill Patients
A study testing Rest in bed and Passive verticalization in people with Critical Illness, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness
- What is being tested?
- Rest in bed and Passive verticalization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteBelgium
- Study dates
- Aug 2014to May 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 10Show fewer
- PEEP > 15 cm H2
- Acute Myocardial Infarction
- Active bleeding
- Intracranial pressure > 20 mm Hg or with major inestability
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Cliniques universitaires Saint-Luc- Université Catholique de Louvain (StLuc)
Brussels, 1200
About this study
Official title: 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)
- Conditions
- Critical Illness
- Being tested
- Rest in bed, Passive verticalization
- Keywords
- Early Physical Exercise, Early Passive Exercise, Alveolar Recruitment, Electrical Impedance Tomography, Oxygenation, Ventilation
- Medical subject headings
- Critical Illness, Motor Activity, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rest in bedOther
Also called Basal position
Passive verticalizationOther
Also called Tilt Table, Early Passive verticalization, Early Assisted verticalization, Early physical therapy
Rest in bedOther
Also called Basal position
| Study group | Role | What they receive |
|---|---|---|
| 1) Rest in bed | Experimental | First evaluation of EIT with patient in bed at 30º of head inclination during 5 minutes. Receives: Other: Rest in bed |
| 2) Passive Verticalization | Experimental | Second evaluation of EIT with patient in tilt table at 60º of verticalization during 10 minutes. Receives: Other: Passive verticalization |
| 3) Rest in bed | Experimental | Last evaluation of EIT with patient in bed at 30º of head inclination during 20 minutes. Receives: Other: Rest in bed |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: Meassure of PaO2 after 20 minutes of passive verticalization and will compared with baseline PaO2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2014 (estimated)
- Study startAug 2014
- Primary completionMay 2016 (estimated)
- Study completionMay 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de Louvain
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Charlotte Meaux, PT, Principal investigator, Cliniques universitaires Saint-Luc- Université Catholique de Louvain (StLuc)Cheryl E Hickmann, PT, PhD student, Principal investigator, Cliniques universitaires Saint-Luc- Université Catholique de Louvain (StLuc)Jean Roeseler, PT, PhD, Study director, Cliniques universitaires Saint-Luc- Université Catholique de Louvain (StLuc)Pierre-François Laterre, MD, Study chair, Cliniques universitaires Saint-Luc- Université Catholique de Louvain (StLuc)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02270762
- Sponsor's protocol ID
- Early passive verticalization
- Acronym
- TILT
- Status last verified
- Nov 2015
- First submitted
- 17 Oct 2014
- Last updated
- 18 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Early Passive Verticalization in Pulmonary Recruitment Evaluated With Electric Impedance Tomography
- ClinicalTrials.gov ID
- NCT02270762
- Acronym / sponsor ID
- TILT / Early passive verticalization
- Conditions
- Critical Illness
- Keywords
- Early Physical Exercise, Early Passive Exercise, Alveolar Recruitment, Electrical Impedance Tomography, Oxygenation, Ventilation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- May 2016 (estimated)
- Study completion
- May 2016 (estimated)
- First posted
- 21 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1) Rest in bed | Experimental | Other: Rest in bedFirst evaluation of EIT with patient in bed at 30º of head inclination during 5 minutes. |
| 2) Passive Verticalization | Experimental | Other: Passive verticalizationSecond evaluation of EIT with patient in tilt table at 60º of verticalization during 10 minutes. |
| 3) Rest in bed | Experimental | Other: Rest in bedLast evaluation of EIT with patient in bed at 30º of head inclination during 20 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- With risk of evisceration
- Therapy withdrawal
- With cardiac devices (Pace Maker)
- Persistent cough
- Patches or open wounds in zone of electrodes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rest in bedAlso: Basal position | Other | 1) Rest in bed |
| Passive verticalizationAlso: Tilt Table, Early Passive verticalization, Early Assisted verticalization, Early physical therapy | Other | 2) Passive Verticalization |
| Rest in bedAlso: Basal position | Other | 3) Rest in bed |
Primary outcome
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.
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charlotte Meaux, PT principal investigator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain (StLuc)
Cheryl E Hickmann, PT, PhD student principal investigator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain (StLuc)
Jean Roeseler, PT, PhD study director
Cliniques universitaires Saint-Luc- Université Catholique de Louvain (StLuc)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rest in bed and Passive verticalization in people with Critical Illness, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2015.