ICU Acquired WeaknessEarlyMobNCT02520193
Impact of Early Mobilization on Mechanical Ventilation Duration in Intubated Critically Ill Patients
A study testing Protocolized early mobilization in ICU in people with ICU Acquired Weakness, run by University Hospital, Angers at 23 sites in 3 countries.
Trial summary
The purpose of the present study is to compare usual care in terms of mobilization performed to intubated ICU patients to a standardized program designed to deliver early mobilization at least 5 days a week. This study has a before / after design with a control group during the experimental phase. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ICU Acquired Weakness
- What is being tested?
- Protocolized early mobilization in ICU
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 772 participants
- Where
- 23 sitesin 3 countries
- Study dates
- Dec 2015to Aug 2018
- 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
- Admission in intensive care unit
- Invasive ventilation for more than 24 hours
- Invasive ventilation for less than 48 hours
- Expected duration of invasive ventilation of more than 24 hours at the time of inclusion.
Who cannot join
- Pregnancy
- Failure to obtain a consent from someone authorized
- Patient under law protection.
- Patient non-affiliated to a health care system.
- Active therapeutic limitation
- Hospitalisation for more than 7 days before intubation
Show all 15Show fewer
- Admission in intensive care unit after a surgical procedure, burn or trauma
- Admission in intensive care unit because of neurological disease
- Previously known neuromuscular disease
- Bilateral lower limbs amputation
- BMI above 40 kg/m²
- Limitation in daily activities before ICU admission
- Chronic ventilation (more than 12h /24 hours) on tracheotomy before ICU admission
- Participation in another interventional clinical study related to mobilization or in an interventional clinical study which has mechanical ventilation duration as primary outcome
- Previous enrolment in the same phase of the EarlyMob study
Trial locations and contacts
23 sites in 3 countries.
23 sites in 3 countries
France17 sites, 17 recruiting
- Recruiting
CHU Angers - Service de Réanimation Médicale et de Médecine Hyperbare
Angers, 49100
Alain MERCAT
- Recruiting
CHU de Brest - Service de réanimation médicale
Brest, 29609
Gwenael PRAT
- Recruiting
CH de Pontoise - Serive de réanimation médicale - CH René Dubos
Cergy-Pontoise, 95303
Cédric CLEOPHAX
- Recruiting
AP-HP Hôpital Henri Mondor - Service de Réanimation Médicale
Créteil, 94010
Keyvan RAZAZI
- Recruiting
CHD Vendée - Service de Réanimation Polyvalente
La Roche-sur-Yon, 85925
Isabelle VINATIER
- Recruiting
Centre Hospitalier La Rochelle - Ré- Aunis - Réanimation polyvalente
La Rochelle, 17000
Maxime LELOUP
- Recruiting
CHU Grenoble - Service de Réanimation Médicale - Hôpital A, Michallon
La Tronche, 38700
Nicolas TERZI
- Recruiting
Centre Hospitalier Le Mans - Service de Réanimation médico-chirurgicale
Le Mans, 72037
Nicolas CHUDEAU
- Recruiting
CHRU de Lille - Pôle de réanimation -Hôpital Roger Salengro
Lille, 59037
Saad NSEIR
- Recruiting
CH St Joseph St Luc - Service de Réanimation Polyvalente
Lyon, 69007
Gael BOURDIN
- Recruiting
Groupe Hospitalier du Havre - Service de Réanimation médico-chirurgicale - Hôpital Jacques Monod
Montivilliers, 76290
Mehdi BOUSTA
- Recruiting
CHU de Nantes - Service de Réanimation Médicale Polyvalente
Nantes, 44093
Christophe GUITTON
- Recruiting
CHU de Nice - Service de réanimation médicale - Hôpital de l'Archet
Nice, 06202
Jean DELLAMONICA
- Recruiting
AP-HP Hôpital Tenon - Service de Réanimation
Paris, 75020
Muriel FARTOUKH
Tai PHAM
- Recruiting
AP-HP Hôpitaux Universitaires Paris Ouest- Service de réanimation médicale - Hôpital Européen Georges Pompidou
Paris, 75908
Jean Luc DIEHL
- Recruiting
CHU Toulouse - service de néphrologie Hémodialyse HTA Transplantation d'Organes - Hôpital Rangueil
Toulouse, 31059
Olivier COINTAULT
- Recruiting
Service de Réanimation Polyvalente -CHU de Toulouse - Hôpital Rangueil
Toulouse, 31059
Stéphanie RUIZ
Belgium5 sites, 5 recruiting
- Recruiting
Hôpital Erasme
Brussels, 1070
Jean-Charles PREISER
- Recruiting
Cliniques Universitaires Saint-Luc - Service des soins intensifs
Brussels, 1200
Xavier WITTEBOLE
- Recruiting
CHR Citadelle - Services Soins intensifs, gériatriques et pédiatriques
Liège, 4000
Vincent FRAIPONT
- Recruiting
CHU de Liege - Service de soins intensifs généraux
Liège, 4000
Pierre DAMAS
- Recruiting
Cliniques Universitaires UCL de Mont-Godinne - Service intensifs généraux
Yvoir, 5530
Geoffrey HORLAIT
Switzerland1 site, 1 recruiting
- Recruiting
CHUV
Lausanne, CH-1011
Lise Piquilloud Imboden, lise.piquilloud@chuv.ch
About this study
Official title: Prospective, Randomized, Multi-center Trial to Assess the Impact of Early Mobilization on Mechanical Ventilation Duration in Intubated Critically Ill Patients
The purpose of the present study is to compare usual care in terms of mobilization performed to intubated ICU patients to a standardized program designed to deliver early mobilization at least 5 days a week.
This study has a before / after design with a control group during the experimental phase. The first phase of the study corresponds to an observational phase during which every act of mobilization performed to the included patients is going to be documented. During this first study period, total duration of mechanical ventilation is going to be recorded for all the patients included.
Read more
At the end of this first study period, the participating ICU are going to be randomized (Cluster randomization) in two groups either observational or experimental. The corresponding strategy is going to be applied to all the patients included during the second study period. During this second period, total duration of mechanical ventilation is also going to be recorded for all the patients included.
The study hypothesis is that applying a protocolized early mobilization strategy increases the number of ventilator free-days during the 28 days after intubation in ICU patients.
- Conditions
- ICU Acquired Weakness
- Being tested
- Protocolized early mobilization in ICU
- Keywords
- Early mobilisation, Invasive ventilation, Ventilator free days, Intensive Care Unit
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protocolized early mobilization in ICUProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Standard mobilization strategy | No intervention | Not described |
| protocolized early mobilization strategy | Experimental | Not described Receives: Procedure: Protocolized early mobilization in ICU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of days without mechanical ventilation (ventilator-free days) during the 28 days after intubation
Measured: 28 days after intubation
Secondary outcomes (9)
The incidence of Intensive Care Unit-acquired weakness with Manual Muscle Testing (MMT) scale
Measured: end of Intensive Care Unit stay, an expected average of 10 days
The incidence and stage of pressure ulcers occurring during ICU stay with NPUAP scale
Measured: end of Intensive Care Unit stay, an expected average of 10 days
The incidence of delirium with CAM-ICU scale
Measured: end of Intensive Care Unit stay, an expected average of 10 days
Hospital stay duration
Measured: End of hospital stay, an expected average of 20 days
Place where the patient is transferred at the end of the hospital stay
Measured: End of hospital stay, an expected average of 20 days
The delay, in number of days between intubation and the first successful spontaneous breathing trial
Measured: End of Intensive Care Unit stay, an expected average of 10 days
The incidence of extubation failure defined as re-intubation within 72 hours after the first extubation
Measured: end of Intensive Care Unit stay, an expected average of 10 days
Time between intubation and the first stand-up position in days
Measured: end of Intensive Care Unit stay, an expected average of 10 days
ICU stay duration
Measured: end of Intensive Care Unit stay, an expected average of 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2015 (estimated)
- Study startDec 2015
- Primary completionDec 2017 (estimated)
- Study completionAug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ICU Acquired WeaknessStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 772 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02520193
- Sponsor's protocol ID
- PHRIP 2014-01
- Other IDs
- 2015-A00741-48
- Acronym
- EarlyMob
- Status last verified
- Jul 2016
- First submitted
- 28 Jul 2015
- Last updated
- 5 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized, Multi-center Trial to Assess the Impact of Early Mobilization on Mechanical Ventilation Duration in Intubated Critically Ill Patients
- ClinicalTrials.gov ID
- NCT02520193
- Acronym / sponsor ID
- EarlyMob / PHRIP 2014-01
- Conditions
- ICU Acquired Weakness
- Keywords
- Early mobilisation, Invasive ventilation, Ventilator free days, Intensive Care Unit
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 772 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- Dec 2015
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Aug 2018 (estimated)
- First posted
- 11 Aug 2015 (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.
The purpose of the present study is to compare usual care in terms of mobilization performed to intubated ICU patients to a standardized program designed to deliver early mobilization at least 5 days a week.
This study has a before / after design with a control group during the experimental phase. The first phase of the study corresponds to an observational phase during which every act of mobilization performed to the included patients is going to be documented. During this first study period, total duration of mechanical ventilation is going to be recorded for all the patients included.
At the end of this first study period, the participating ICU are going to be randomized (Cluster randomization) in two groups either observational or experimental. The corresponding strategy is going to be applied to all the patients included during the second study period. During this second period, total duration of mechanical ventilation is also going to be recorded for all the patients included.
The study hypothesis is that applying a protocolized early mobilization strategy increases the number of ventilator free-days during the 28 days after intubation in ICU patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard mobilization strategy | No intervention | – |
| protocolized early mobilization strategy | Experimental | Procedure: Protocolized early mobilization in ICU |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Admission in intensive care unit
- Invasive ventilation for more than 24 hours
- Invasive ventilation for less than 48 hours
- Expected duration of invasive ventilation of more than 24 hours at the time of inclusion.
Key exclusion criteria (15 listed)
- Pregnancy
- Failure to obtain a consent from someone authorized
- Patient under law protection.
- Patient non-affiliated to a health care system.
- Active therapeutic limitation
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 |
|---|---|---|
| Protocolized early mobilization in ICU | Procedure or surgery | protocolized early mobilization strategy |
Primary outcome
Number of days without mechanical ventilation (ventilator-free days) during the 28 days after intubation
Time frame: 28 days after intubation
9 secondary outcomes
The incidence of Intensive Care Unit-acquired weakness with Manual Muscle Testing (MMT) scale
Time frame: end of Intensive Care Unit stay, an expected average of 10 days
The incidence and stage of pressure ulcers occurring during ICU stay with NPUAP scale
Time frame: end of Intensive Care Unit stay, an expected average of 10 days
The incidence of delirium with CAM-ICU scale
Time frame: end of Intensive Care Unit stay, an expected average of 10 days
Hospital stay duration
Time frame: End of hospital stay, an expected average of 20 days
Place where the patient is transferred at the end of the hospital stay
Time frame: End of hospital stay, an expected average of 20 days
The delay, in number of days between intubation and the first successful spontaneous breathing trial
Time frame: End of Intensive Care Unit stay, an expected average of 10 days
The incidence of extubation failure defined as re-intubation within 72 hours after the first extubation
Time frame: end of Intensive Care Unit stay, an expected average of 10 days
Time between intubation and the first stand-up position in days
Time frame: end of Intensive Care Unit stay, an expected average of 10 days
ICU stay duration
Time frame: end of Intensive Care Unit stay, an expected average of 10 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2017.
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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.
23 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Protocolized early mobilization in ICU in people with ICU Acquired Weakness, run by University Hospital, Angers at 23 sites in 3 countries.
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 4 inclusion and 15 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 5 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in France, Belgium, Switzerland. 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?
Contact Laurent POIROUX (++33 2 41 35 64 40, LaPoiroux@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of days without mechanical ventilation (ventilator-free days) during the 28 days after intubation (time frame: 28 days after intubation). 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 5 May 2017.