Critically Ill Patients Under Mechanical VentilationPhase 3NCT02920684
Haemodynamic and Metabolism Response During Early Rehabilitation in Sedated Patients
A Phase 3 study testing Passive legs mobilisation, Passive cycloergometer and Muscular electrical stimulation in people with Critically Ill Patients Under Mechanical Ventilation and Sedated Patients, run by University Hospital, Rouen at 1 site in France.
Trial summary
Despite several positive studies, benefits of early rehabilitation on recovery and motor performance improvement need to be demonstrate. A recent study finds that despite early rehabilitation, 1 survivor of 2 (52%) acquired an ICU weakness. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critically Ill Patients Under Mechanical Ventilation, Sedated Patients
- What is being tested?
- Passive legs mobilisation, Passive cycloergometer and Muscular electrical stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2016to Aug 2017
- Phase
- Phase 3
- 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
- Mechanical ventilation
- Sedated
- Ramsay < 4
Who cannot join
- Rehabilitation contraindication
- Patient with pacemaker
- Patient under volume assist control
- FiO2 > 80%
- Patient under neuromuscular blockers
- Neurologic comorbidity
Trial locations and contacts
1 site in 1 country.
About this study
Despite several positive studies, benefits of early rehabilitation on recovery and motor performance improvement need to be demonstrate. A recent study finds that despite early rehabilitation, 1 survivor of 2 (52%) acquired an ICU weakness. The low intensity exercises applied in intensive care is common and most patients stay in bed.
Under these conditions, the optimal choice of the rehabilitation technique for bedridden patient and its intensity should be studied.
The objective of the study is to evaluate the cardiovascular and metabolic response of patients during four interventions: Passive legs mobilization, Passive cycloergometter, Quadriceps neuromuscular electrical stimulation and Functional electrical stimulation.
- Being tested
- Passive legs mobilisation, Passive cycloergometer, Muscular electrical stimulation, FES cycling
- Keywords
- Early rehabilitation, Mechanical ventilation, Physiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Passive legs mobilisationOther
A physiotherapist performs a passive leg movement
Passive cycloergometerOther
A motorised cycloergometer performs a passive cycling
Muscular electrical stimulationOther
A neuromuscular electrical stimulation device performs a quadriceps located stimulation
FES cyclingOther
A motorised cycloergometer performs a passive cycling with quadriceps neuromuscular stimulation
| Study group | Role | What they receive |
|---|---|---|
| Passive legs mobilisation | Active comparator | A physiotherapist performs passive legs movement Receives: Other: Passive legs mobilisation |
| Passive cycloergometer | Active comparator | A motorized cycloergometer performs passive legs cycling Receives: Other: Passive cycloergometer |
| Muscular electrical stimulation | Active comparator | Quadriceps neuromuscular electrical stimulation Receives: Other: Muscular electrical stimulation |
| FES cycling | Active comparator | A motorised cycloergometer performs a quadriceps neuromuscular electrical stimulation during passive Receives: Other: FES cycling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac output by cardiac ultrasonography
Measured: Every 3 minutes during 10 minutes exercise
Secondary outcomes (5)
Muscular oxygenation of vastus lateralis muscle by Near Infrared Spectroscopy
Measured: Continuously during ten minutes exercise
Pulmonary artery Pressure by cardiac ultrasonography
Measured: Every 3 minutes during 10 minutes exercise
Tricuspid annular plane systolic excursion by cardiac ultrasonography
Measured: Every 3 minutes during 10 minutes exercise
Expiratory volume
Measured: Continuously during ten minutes exercise
Respiratory rate
Measured: Continuously during ten minutes exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2016 (estimated)
- Study startDec 2016
- Primary completionAug 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Critically Ill Patients Under Mechanical VentilationStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, BOUCHRA LAMIA, University Hospital, Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02920684
- Sponsor's protocol ID
- 2015-A01633-46
- Status last verified
- Aug 2017
- First submitted
- 25 Sep 2016
- Last updated
- 2 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Medrinal C, Combret Y, Prieur G, Robledo Quesada A, Bonnevie T, Gravier FE, Dupuis Lozeron E, Frenoy E, Contal O, Lamia B. Comparison of exercise intensity during four early rehabilitation techniques in sedated and ventilated patients in ICU: a randomised cross-over trial. Crit Care. 2018 Apr 27;22(1):110. doi: 10.1186/s13054-018-2030-0.
PubMed 29703223Medrinal C, Combret Y, Prieur G, Robledo Quesada A, Bonnevie T, Gravier FE, Frenoy E, Contal O, Lamia B. Effects of different early rehabilitation techniques on haemodynamic and metabolic parameters in sedated patients: protocol for a randomised, single-bind, cross-over trial. BMJ Open Respir Res. 2017 Jan 30;4(1):e000173. doi: 10.1136/bmjresp-2016-000173. eCollection 2017.
PubMed 28255448
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Haemodynamic and Metabolism Response During Early Rehabilitation in Sedated Patients
- ClinicalTrials.gov ID
- NCT02920684
- Acronym / sponsor ID
- 2015-A01633-46
- Keywords
- Early rehabilitation, Mechanical ventilation, Physiotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 30 Sep 2016 (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.
Despite several positive studies, benefits of early rehabilitation on recovery and motor performance improvement need to be demonstrate. A recent study finds that despite early rehabilitation, 1 survivor of 2 (52%) acquired an ICU weakness. The low intensity exercises applied in intensive care is common and most patients stay in bed.
Under these conditions, the optimal choice of the rehabilitation technique for bedridden patient and its intensity should be studied.
The objective of the study is to evaluate the cardiovascular and metabolic response of patients during four interventions: Passive legs mobilization, Passive cycloergometter, Quadriceps neuromuscular electrical stimulation and Functional electrical stimulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Passive legs mobilisation | Active comparator | Other: Passive legs mobilisationA physiotherapist performs passive legs movement |
| Passive cycloergometer | Active comparator | Other: Passive cycloergometerA motorized cycloergometer performs passive legs cycling |
| Muscular electrical stimulation | Active comparator | Other: Muscular electrical stimulationQuadriceps neuromuscular electrical stimulation |
| FES cycling | Active comparator | Other: FES cyclingA motorised cycloergometer performs a quadriceps neuromuscular electrical stimulation during passive |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Mechanical ventilation
- Sedated
- Ramsay < 4
Key exclusion criteria (6 listed)
- Rehabilitation contraindication
- Patient with pacemaker
- Patient under volume assist control
- FiO2 > 80%
- Patient under neuromuscular blockers
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 |
|---|---|---|
| Passive legs mobilisationA physiotherapist performs a passive leg movement | Other | Passive legs mobilisation |
| Passive cycloergometerA motorised cycloergometer performs a passive cycling | Other | Passive cycloergometer |
| Muscular electrical stimulationA neuromuscular electrical stimulation device performs a quadriceps located stimulation | Other | Muscular electrical stimulation |
| FES cyclingA motorised cycloergometer performs a passive cycling with quadriceps neuromuscular stimulation | Other | FES cycling |
Primary outcome
Cardiac output by cardiac ultrasonography
Time frame: Every 3 minutes during 10 minutes exercise
5 secondary outcomes
Muscular oxygenation of vastus lateralis muscle by Near Infrared Spectroscopy
Time frame: Continuously during ten minutes exercise
Pulmonary artery Pressure by cardiac ultrasonography
Time frame: Every 3 minutes during 10 minutes exercise
Tricuspid annular plane systolic excursion by cardiac ultrasonography
Time frame: Every 3 minutes during 10 minutes exercise
Expiratory volume
Time frame: Continuously during ten minutes exercise
Respiratory rate
Time frame: Continuously during ten minutes exercise
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2017.
- Derived from this study: PubMed 29703223Medrinal C, Combret Y, Prieur G, Robledo Quesada A, Bonnevie T, Gravier FE, Dupuis Lozeron E, Frenoy E, Contal O, Lamia B. Comparison of exercise intensity during four early rehabilitation techniques in sedated and ventilated patients in ICU: a randomised cross-over trial. Crit Care. 2018 Apr 27;22(1):110. doi: 10.1186/s13054-018-2030-0.
- Derived from this study: PubMed 28255448Medrinal C, Combret Y, Prieur G, Robledo Quesada A, Bonnevie T, Gravier FE, Frenoy E, Contal O, Lamia B. Effects of different early rehabilitation techniques on haemodynamic and metabolic parameters in sedated patients: protocol for a randomised, single-bind, cross-over trial. BMJ Open Respir Res. 2017 Jan 30;4(1):e000173. doi: 10.1136/bmjresp-2016-000173. eCollection 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Passive legs mobilisation, Passive cycloergometer and Muscular electrical stimulation in people with Critically Ill Patients Under Mechanical Ventilation and Sedated Patients, run by University Hospital, Rouen at 1 site in France.
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 3 inclusion and 6 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: finished, as of the sponsor's last update on 2 Aug 2017. 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 France. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Cardiac output by cardiac ultrasonography (time frame: Every 3 minutes during 10 minutes exercise). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02920684, which also lists 2 linked publications.
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 2 Aug 2017.